Generics Industry News Search
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June 2007 News Archive |
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HAYWARD, Calif.--(BUSINESS WIRE)--Jun 1, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. District Court for the Southern District of New York has rendered a decision in IMPAX's patent litigation with AstraZeneca involving IMPAX's Abbreviated New Drug Applications (ANDA) for generic versions of Prilosec(R) (omeprazole)...
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WOODCLIFF LAKE, N.J., June 01, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that the Commercial Court, Zagreb, Croatia announced a judgment requiring its subsidiary, PLIVA d.d., to pay ... (approximately USD $15 million), to certain former employees in connection with the invention of a process for manufacturing Azithromycin....
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WOODCLIFF LAKE, N.J., June 1 (UPI) -- U.S. generic drug firm Barr said Friday its Croation unit Pliva has been ordered to pay $8 million in patent damages related to azithromycin.
Click here to read full article (www.upi.com)...
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/Orange Book Blog/ Aaron Barkoff's summary of what's news in Pharma reports and litigation....
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/Motley Fool/ June 1, 2007 -- Earlier in the week, Pfizer received word that a Norwegian appeals court had given the go-ahead for generic drugmaker Ranbaxy to market a generic version of Pfizer's top-selling cholesterol-lowering drug, Lipitor. Nowadays, the drug business is not just about R&D.; Yes, drugmakers need to have a strong drug development pipeline -- but they also must have a good legal team to defend against the challenges by generic manufacturers to their product's patents...
Click here to read full article (www.fool.com)
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/Australia and New Zealand Health Policy/ 1 June 2007 --This article describes the policy environment for the community pharmacy sector in Australia, with a particular focus on present challenges arising from proposals to achieve substantial PBS cost savings from an anticipated surge of new generic drugs. Some $2 billion of medicines currently on the PBS will come off patent in the next 4 years. This growth comes from a low base where generics currently account for only 15% of the total PBS budget...
Click here to read full article (www.anzhealthpolicy.com)...
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/Triangle Business Journal/ June 1, 2007 -- Synthon Pharmaceuticals has scaled down its growth and business plans, opting for a minor space renovation and abandoning efforts to create its own branded drugs. The company is now focused on gaining federal approval for and selling generic drugs. "We're doing this step-by-step the way it should have been done in the first place," says Michael Hinckle, vice president and general counsel for Synthon's U.S. operations...
Click here to read full article (www.bizjournals.com)...
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/The Economic Times Online/ NEW DELHI:JUNE 02, 2007 -- Multinational drug makers like Pfizer, Glaxo and Novartis can look forward to delaying the entry of me-too versions of their new drugs in India for five years. To get that limited protection from local competition, they may be compelled to launch their latest blockbuster drugs in India as soon as they launch anywhere else and sacrifice the right to price them at their sweet will. The Satwant Reddy panel set up to recommend if India should allow MNC drug makers and agrochemicals makers to prevent rivals from launching copies relying on the inventor’s own data, has submitted its report to the government on Thursday. It recommends...
Click here to read full article (economictimes.indiatimes.com)...
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/Business Standard/ New Delhi June 03, 2007 -- A government committee has ruled out the possibility of India stopping its local pharma firms from relying on drug trial data of multinational pharma companies. This implies that local companies will continue to use this data for selling copycat versions of drugs invented by MNC firms. ... The government has been under tremendous pressure from the US to introduce a system of data protection in pharmaceuticals.
Click here to read full article (www.business-standard.com)
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/Financial Express/ Mumbai, Jun 3 -- Losing patent litigations for generic approvals of patented drugs is nothing new for Indian pharma companies. However, for Hyderabad-based Dr Reddy's Labs, losing a recent patent litigation with US-based Eli Lilly and Company could come as a big relief rather than a defeat, as concerns over the safety of the schizophrenia drug in question are on the rise.
Click here to read full article (www.financialexpress.com)...
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/Patent Docs Blog/ By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Takeda v. Teva (lansoprazole), Teva v Torrent (Sertraline), Cornerstone v. Provident (AlleRx®), Aventis v Sandoz (fexofenadine)...
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North Wales, Pennsylvania, June 4, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Alprazolam Extended-Release Tablets, CIV. This product is AB rated and bioequivalent to Xanax®* XR Tablets....
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PITTSBURGH, June 05, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Court of Appeals for the Federal Circuit today granted its motion for a reversal of the district court judgment in its patent infringement litigation with Pfizer concerning amlodipine besylate....
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WOODCLIFF LAKE, N.J., June 05, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Janssen Pharmaceutica Products, L.P.'s Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg....
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BANGALORE, India, 6-Jun-07: Strides Arcolab today announced that it has received tentative approvals from the United States - Food and Drug Administration for two new drug applications [NDA] for fixed dose combination of:
* Lamivudine/Stavudine 150 mg/40 mg tablets co-packaged with Efavirenz 600mg tablets And
* Lamivudine/Zidovudine 150/300 mg tablets co-packaged with Efavirenz 600mg tablets...
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LONDON--(BUSINESS WIRE)--Jun 6, 2007 - Just three of the 13 patented drugs that dominated the global market for central nervous System (CNS) treatments in 2005 will be free from generic competition in 2010, concludes a new report on the CNS pharmaceutical market....
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CRANBERRY TOWNSHIP, Pa., June 6 /PRNewswire/ -- Three Rivers Pharmaceuticals, LLC, a leading specialty drug manufacturer today announced that it has sued Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited for infringement of Three Rivers' United States Patent No. 6,720,000. The '000 patent is directed to a new and important process for producing ribavirin pellets using wet granulation....
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/Orange Book Blog/ June 06, 2007 -- In an opinion released Tuesday, Judge William H. Pauley III of the U.S. District Court for the Southern District of New York ruled that Merck's patent on the formulation for Pepcid Complete is invalid as obvious, clearing the way for Perrigo Co. to sell its own generic version of the medication. The decision is one of the first pharmaceutical patent decisions to rely on and quote extensively from the Supreme Court's April 30 decision in KSR v. Teleflex....
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INDIANAPOLIS, June 07, 2007 /PRNewswire-FirstCall/ -- Eli Lilly and Company today responded to two recent court rulings by the Canadian Federal Court and the German Patent Court that could result in the entry of generic olanzapine (Zyprexa) into the Canadian and German markets....
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/Patent Baristas/ June 7th, 2007 -- The Analysis Group released a report on the impact of authorized generic entry on paragraph IV certifications. The report, “Do Authorized Generic Drugs Deter Paragraph IV Certifications?,” was co-authored by academic affiliate Professor Ernst R. Berndt of MIT’s Sloan School of Management, Analysis Group Vice President Richard Mortimer, and Managing Principal Andrew Parece....
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/In-Pharma Technologist/ 07/06/2007 -- Siegfried Generics this week kicked off production at its new manufacturing facility in Malta making the most of the country's lack of pharma patents which gives the firm a head-start in producing generic pharmaceuticals.
Click here to read full article (www.in-pharmatechnologist.com)...
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PITTSBURGH, June 08, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Tablets, 150 mg....
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/Patent Baristas/ June 8th, 2007 -- In another stirring chapter of the on-going Plavix debacle, the Bristol-Myers Squibb pleaded guilty to two criminal counts of two violations of the federal False Statements Act and will pay a $1 million fine (the maximum penalty) for lying to the federal government about a patent deal involving the anticoagulant drug Plavix (clopidogrel bisulfate)....
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/OrangeBook Blog/ Recent news stories of interest selected by Aaron Barkoff...
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/PharmaTimes/ 10/06/2007 -- India's goal of becoming a world-leading centre for pharmaceutical R&D; could be jeopardised by a clause in the country's new patent law, a leading industry figure has warned. ... In order to become TRIPs-compliant, India has amended its patent laws, but the new legislation contains a clause which Prof Jones believes could seriously compromise...
Click here to read full article (www.pharmatimes.com)...
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BASEL, Switzerland, June 11, 2007 - Novartis will immediately launch its own generic version of Lotrel® in the United States through its Sandoz division after a federal court judge today declined a request from Novartis to stop Teva Pharmaceuticals from resuming shipments of generic copies of the hypertension drug....
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JERUSALEM, Israel--(BUSINESS WIRE)--Jun 11, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. District Court for the District of New Jersey has vacated a temporary restraining order in effect since May 23, 2007 and denied a motion filed by Novartis for a preliminary injunction related to Teva's amlodipine besylate/ benazepril products, AB rated to Novartis' Lotrel(R)....
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WOODCLIFF LAKE, N.J., June 11, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., today announced the dismissal of litigation related to its challenge of the patent protecting Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets...
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By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week:
Pfizer v. Teva (atorvastatin), Purdue v. KV (oxycodone)...
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INDIANAPOLIS, June 11 /PRNewswire-FirstCall/ -- The expanded use of generic statins can provide equal cardiovascular benefits to a majority of patients being treated for high cholesterol while offering substantial cost savings over brand-name drugs, according to a study conducted by HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc....
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/Congressional Quarterly/ June 11, 2007 -- Panelists at an American Enterprise Institute policy forum Monday highlighted recommendations and potential pitfalls ahead for proposed congressional legislation to create a regulatory pathway for follow-on biologics...
Click here to read full article (public.cq.com)...
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/New York Times/ June 11, 2007 -- THE cancer drugs produced at Genentech’s gleaming factory here are the vanguard of 21-century biotechnology. But the way the drugs are made is ... part art, part science. Results can differ from factory to factory, or even between lots in a single site. ... Such vagaries lie at the heart of a debate going on in Congress ... Genentech says the pharmaceutical companies should not be allowed [to make generics], arguing that other companies could not replicate its drugs precisely because the process is so complex.
Click here to read full article (www.nytimes.com)
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FAIRFIELD, N.J., June 12, 2007 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. today announced the launch of its authorized generic version for ADOXA(R) 150 mg strength doxycycline monohydrate tablets. In accordance with a licensing and distribution agreement with Par Pharmaceutical Companies, Inc....
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/Business Standard/ Mumbai June 12, 2007 -- Swiss pharmaceutical major Hoffmann-La Roche’s patents rights over Hepatitis C drug Pegasys has been challenged by public interest groups at the Indian Patent Office. This is the second post-grant opposition filed against Pegasys, ... Pegasys was the first drug to receive patent production and subsequent market monopoly according to the changed patent law of 2005. Its patent is valid in India until May 16, 2017.
Click here to read full article (www.business-standard.com)...
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HAWTHORNE, N.Y.-- (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. today announced that it has scheduled an Extraordinary General Meeting to be held on July 23, 2007. At the Meetings, shareholders will be asked to approve and adopt the previously announced agreement of merger, dated May 18, 2007, between the Company and Aditya Acquisition Company Ltd., an Israeli Company and a wholly owned subsidiary of Alkaloida Chemical Company Exclusive Group Ltd., a subsidiary of Sun Pharmaceutical Industries Ltd....
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/Orange Book Blog/ June 12, 2007 -- Yesterday, a federal judge denied a preliminary injunction motion filed by Novartis to protect Lotrel from generic competition. With the decision, Teva likely resumed shipping its generic version of Lotrel before nightfall....
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BALTIMORE, Md., June 13, 2007 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg....
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/In-Pharma Technologist/ 13.06.2007 -- Relaunching pharmaceutical products in a bid to preserve an earlier product's existing market share and maintain revenues is a common tactic in the pharma industry, but, as a recent report notes, kicking off development plans early can make all the difference. The report, published by research group Cutting Edge Information, analyses line extensions and new market entry strategies as mechanisms to preserve a brand's place in the market and defend against the ever-present threat of generics...
Click here to read full article (www.in-pharmatechnologist.com)...
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ORONA, Calif., June 13, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced that it has received final approval from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for bupropion hydrochloride extended-release tablets...
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DUBLIN, Ireland-- (BUSINESS WIRE) -- Research and Markets (http://www.researchandmarkets.com/reports/c59542) has announced the addition of Australia Pharmaceuticals & Healthcare Report Q4 2006 to their offering. The Australia Pharmaceuticals & Healthcare Report provides independent forecasts and competitive intelligence on Australia's pharmaceuticals & healthcare industry....
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/Patent Docs Blog/ June 13, 2007 -- On Monday, the U.S. Supreme Court denied a motion to expedite consideration of a petition for a writ of certiorari filed by Pfizer Inc. in Pfizer Inc. v. Apotex, Inc. (2007). The Chief Justice took no part in the consideration or decision of Pfizer's motion. ... Pfizer's '303 patent relates to amlodipine besylate (sold by Pfizer under the trademark Norvasc®)...
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/The Guardian/ June 13, 2007 -- The pharmaceutical industry business model is "economically unsustainable", according to a report by accountants PricewaterhouseCoopers. The study suggested drug companies' reliance on heavy marketing of a few drugs in the hope of huge sales meant they were "operationally incapable" of acting quickly enough to produce innovative treatments demanded by global markets...
Click here to read full article (business.guardian.co.uk)...
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/Medical Journal of Australia/ 13 June 2007 -- ... Proposed changes to PBS processes were laid out in legislation introduced to Federal Parliament on 24 May 2007, which will amend the National Health Act 1953 (Cwlth).2 ... Our main concerns are that the proposed changes to the PBS will lead to higher prices for drugs that offer no advantage over existing products, and will fail to provide very low-cost generic products that would ease the financial burden on patients and their families. We suggest some alternative approaches...
Click here to read full article (www.mja.com.au)
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PharmaBiz Bureau, Mumbai, June 14, 2007 18:00 IST -- Wockhardt Ltd is on the final stage of negotiations to acquire the Illinois based Morton Grove Pharmaceuticals to increase its presence in the US market, according to a media report. Morton Grove is a specialty pharmaceutical company with a strong presence in manufacturing of liquids and inhaled generics products...
Click here to read full article (www.pharmabiz.com)...
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/Times News Network/ June 14, 2007 MUMBAI: As blockbuster drugs are set to lose exclusivity in the US, Indian pharma companies are gearing up to tap the fast-growing generic peptide drugs market. According to Frost & Sullivan, half of the $5-6 billion global market for peptide — molecules consisting of two or more amino acids, the most common example being insulin — is set to go off patent in the next four years.
Click here to read full article (economictimes.indiatimes.com)...
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/McDermott, Will & Emery/ 14 June 2007 -- ... the United States District Court for the District of Columbia denied all requests for preliminary injunction related to amlodipine besylate tablets and supported the U.S. Food and Drug Administration’s (FDA) position concerning Mylan’s current status as holder of the only approved Abbreviated New Drug Application (ANDA) ... all of the unapproved amlodipine besylate ANDAs are currently blocked from approval by pediatric exclusivity.
Click here to read full article (www.mondaq.com)...
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TOKYO, June 14, 2007 – DAIICHI SANKYO CO., LTD. (President & CEO: Takashi Shoda), ... today announced that the Canadian Federal Appeal Court affirmed the decision of the Canadian Federal Court in Toronto, which held that Daiichi Sankyo’s patent (No. 1,304,080) on its antibacterial agent, levofloxacin, is valid and infringed by generic levofloxacin tablets of Novopharm Limited....
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Chennai, India – June 15, 2007 -- The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received the tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg Tablets....
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Hyderabad, June 15, 2007 -- Aurobindo Pharma Limited is pleased to announce that the company has received approval from the USFDA for Trandolapril Tablets 1 mg, 2 mg & 4 mg. Trandolapril is the Generic equivalent of Abbott's Mavik® Tablets, indicated for the treatment of hypertension....
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Hyderabad, June 15, 2007 -- Aurobindo Pharma Limited is pleased to announce that the USFDA has approved one more from its cephalosporin stable and again from its third generation breed. Cefpodoxime proxetil Tablets in the strengths of 100mg and 200mg has been approved. This is the 7th cephalosporin approval for Aurobindo. With this the company consolidates itself further in cephalosporin market. Cefpodoxime is the generic version of Pharmacia Upjohn’s Vantin....
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/Patently-O Blog/ Jun 16, 2007 -- Abbott and Sandoz are in a tussle over Abbott’s patented clarithromycin antibiotic (BIAXIN). Abbott sued Sandoz and was granted a preliminary injunction in April 2007. Sandoz immediately requested a stay of the preliminary injunction pending appeal to the Federal Circuit. ...
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/Orange Book Blog/ June 16, 2007 -- Aaron Barkoff lists recent news stories of interest...
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/Patent Docs/ In this week: Sanofi-Aventis v. Sandoz (oxaliplatin)...
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/Drug Discovery & Development/ June 2007 -- When it comes to brand-name pharmaceuticals, marketing is big business, and there are plenty of targets. The pharmaceutical industry spent about $7.2 billion on promoting their products to physicians in 2005, and about $4.2 billion on direct-to-consumer advertising. So how do [Generics] companies—like Ranbaxy, Mylan, Watson, and GenPharm—market their generic drug against all the other manufacturers, when it's the exact same product?
Click here to read full article (www.dddmag.com)...
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BEDFORD, OH – June 18, 2007 – Bedford Laboratories™, a division of Ben Venue Laboratories Inc., announced FDA approval to begin shipping Deferoxamine Mesylate for Injection USP. This product is AP rated and is equivalent to Desferal® by Novartis. ...
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PARIS, June 18 (Reuters) - Sanofi-Aventis (SASY.PA: Quote, Profile, Research) on Monday confirmed it had filed a lawsuit against Sandoz, a unit of Novartis (NOVN.VX: Quote, Profile, Research), over its plans to sell a generic version of the French drugmaker's cancer treatment Eloxatin...
Click here to read full article (www.reuters.com)...
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/WSJ Live Mint/ New Delhi Mon, Jun 18 2007 -- This week, Swiss drug maker Novartis AG is bracing for two crucial legal decisions in its Glivec patent battle in India. The newly appointed patent cell at the Intellectual Property Appellate Board (IPAB) will on Monday hear its first ever patent appeal—in which Novartis has challenged a Chennai patent office’s early-2006 decision to reject its patent application for the cancer drug on the grounds that Glivec didn’t qualify for protection under what was then a newly-minted patents law.
Click here to read full article (www.livemint.com)...
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HAYWARD, Calif.--(BUSINESS WIRE)--Jun 19, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that Abbott Laboratories has filed a lawsuit against the Company alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for generic versions of Depakote(R) ER 250mg and 500mg tablets. IMPAX's submission includes a Paragraph IV certification stating the Company believes its product does not infringe Abbott's listed patents or that the listed patents are invalid....
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/Times News Network/ June 19, 2007 Mumbai -- In a new twist to the globally-publicised Glivec case, Novartis has objected to the appointment of the former controller general of patents Chandrasekaran to hear its appeal. The company has argued that he was responsible for the rejection of Glivec’s patent application in the first place.
Click here to read full article (economictimes.indiatimes.com)...
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BOSTON (Dow Jones) June 19, 2007 -- A federal court has ruled that a key patent held by Sanofi-Aventis on the blockbuster drug Plavix is valid -- a move that's likely to stave off generic competition for the popular blood-clot medication until 2011...
Click here to read full article (money.cnn.com)...
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NEW YORK, June 19 /PRNewswire-FirstCall/ -- Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) and Bristol-Myers Squibb Company (New York: NYSE: BMY) announced today that the U.S. District Court for the Southern District of New York has upheld the validity and enforceability of U.S. patent 4,847,265 covering clopidogrel bisulfate, the active ingredient in Plavix®, maintaining the main patent protection for this product in the United States until November 2011....
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/Orange Book Blog/ June 19, 2007 -- Following a month-long trial held earlier this year, in an opinion released today a federal district court upheld the validity of Sanofi's U.S. Patent No. 4,847,265. The '265 patent covers clopidogrel bisulfate, the active ingredient in Plavix. The court permanently enjoined Canadian generic drug maker Apotex from infringing the '265 patent and stated that damages will be set in future proceedings....
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/Patent Baristas/ June 19th, 2007 -- After refusing to die easy on its bid to put out a generic version of Plavix, Apotex was handed its hat by the district court. Sanofi-Synthelabo v. Apotex Inc., 02cv2255, U.S. District Court, Southern District of New York....
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/Patent Docs/ June 19, 2007 -- Sanofi-Aventis and Bristol-Myers Squibb announced today (June 19, 2007) that the U.S. District Court for the Southern District of New York has issued a ruling in their favor in an infringement action against Apotex. Sanofi and BMS filed the action in March of 2002, contending that Apotex' filing of an ANDA for clopidogrel bisulfate tablets infringed Sanofi's U.S. Patent No. 4,847,265...
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PRINCETON, N.J., June 20, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base)....
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/Patent Docs Blog/ June 19 & 20, 2007 -- [For rising drug costs] the solution, for many, is to be found in cheap generic drugs from any number of manufacturers, which companies have one thing increasingly in common: the source of their drugs, whether the active pharmaceutical ingredient or the finished drug itself, comes from a foreign company, where its manufacturing plants are far from the watchful eye of the Food and Drug Administration (FDA). Despite this, those same politicians, NGOs, and consumers take it on faith that they can rely on the FDA to oversee the safety and efficacy of generic drugs from these sources. But they may be very wrong....
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ALLEGAN, Mich., June 20 /PRNewswire-FirstCall/ -- The Perrigo Company announced today that the U.S. Food & Drug Administration (FDA) has granted tentative approval to Dexcel Pharma Technologies, Ltd. (Dexcel) for its new drug application (NDA) for 20 mg omeprazole delayed- release tablets. Once final approval has been granted by the FDA, Perrigo will be the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States.
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jun 21, 2007 - Akorn, Inc. (NASDAQ: AKRX) and Cipla, Ltd., a leading Indian pharmaceutical company located in Mumbai, India, today announced the signing of an exclusive drug development and supply agreement for an oral ANDA drug product for the prevention of organ transplant rejection. According to 2006 IMS data, this drug product has a total market size of approximately $750 million for all indications....
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BOSTON, June 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today reported that the U.S. District Court for the District of Massachusetts ruled in favor of the company and dismissed all claims relating to Schering-Plough's branded pharmaceutical products in a class action lawsuit involving several pharmaceutical companies and the setting of average wholesale prices (AWPs) for prescription products. ... the Court's finding of limited liability against Warrick with respect to one form of a generic product, albuterol sulfate solution, in the years 1998 and 1999....
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June 21 (Bloomberg) -- Dr. Reddy's Laboratories Ltd., India's biggest drugmaker, is developing eight generic medicines using biotechnology and plans to release one for sale a year, challenging companies such as Roche Holding AG and Amgen Inc. Reddy's may double the number of people in its biotech division to about 340 in the next two years and plans to spend about $20 million bolstering production capacity there, Chief Executive Officer G.V. Prasad said yesterday.
Click here to read full article (www.bloomberg.com)...
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Chennai, India – June 21, 2007 -- The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) announced that it has received approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Cefepime injection....
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June 21, 2007 -- WASHINGTON (Reuters) - A U.S. House of Representatives committee voted on Thursday to give the Food and Drug Administration more power to monitor the side effects of medicines after they reach the market. The FDA would have the authority to require post-approval studies of new medicines or order additional warnings under legislation that cleared the House Energy and Commerce Committee in a 39-0 vote...
Click here to read full article (www.sciam.com)...
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/Associated Press/ 06.21.07 -- Australia's largest maker of generic drugs, Sigma Pharmaceuticals Ltd., says it still wants to buy health care giant Symbion Health Ltd.'s consumer products and drug distribution units after a private equity consortium trumped its bid by a dollar...
Click here to read full article (www.forbes.com)...
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/Glenmark/ Mumbai, June 21, 2007: Glenmark Pharmaceuticals Ltd., a researchbased pharmaceutical company headquartered in Mumbai (India) received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg oral tablets. It is the AB-rated generic equivalent of Novartis's anti-fungal Lamisil® tablets...
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/Natco/ June 21, 2007 -- NATCO Pharma Limited, the Hyderabad based pharma company has announced the launch of a world class oral contraceptive under the brand name Tarana. Tarana, which contains Drospirenone 3 mg and Ethinyl Estradiol 0.03 mg, will be the first generic version of the international brand....
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PRINCETON, N.J., June 22, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Tamsulosin Hydrochloride Capsules, 0.4 mg....
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WOODCLIFF LAKE, N.J., June 22, 2007 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. , today announced that it received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Roche Laboratories Inc.'s VESANOID(R) (tretinoin) Capsules, 10 mg. The Company is the first to market a generic version of this product in the U.S. and plans to launch its product immediately....
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HOLZKIRCHEN (Germany), June 22, 2007 - Sandoz is the first company to receive a positive opinion from European Union regulators supporting the approval of a biosimilar version of epoetin alfa, achieving another important milestone in its efforts to bring follow-on biological medicines to patients....
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June 22 (Bloomberg) -- Thailand plans to buy more generic AIDS drugs from India to cut the cost of treating its poorest patients after failing to win large enough discounts from drugmakers including Merck & Co. and Abbott Laboratories. Public Health Minister Mongkol Na Songkhla said he will order more copies of Merck's Stocrin from Matrix Laboratories Ltd., a unit of U.S.-based Mylan Laboratories Inc., and plans to buy generic versions of two other life-saving drugs from India...
Click here to read full article (www.bloomberg.com)...
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/PharmaBiz/ Bangalore, June 22, 2007 -- Health Care Global Enterprises (HCG), a cancer care and research centre, has inked a pact with Sun Moon Pharma in Ahmedabad for the production of generics in oncology. The first two products, Pacitaxol and Docetexol, will be introduced in July this year. These are first line therapies for breast, head and neck and ovarian cancers at a cost 25 per cent lesser than existing drugs.
Click here to read full article (www.pharmabiz.com)...
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/Business Daily/ 22-June-2007, Nairobi -- An estimated 1.2 million people living with HIV in Kenya could soon have easier access to life-prolonging drugs. Currently, only 120,000 people living with HIV have access to Antiretroviral Therapy (ART), ... Universal Corporation Limited, which started commercial production last year, has been licensed by Swiss drug maker Roche Pharmaceuticals to produce the generic equivalent of saquinavir, its second-line HIV drug.
Click here to read full article (www.bdafrica.com)...
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/Boston Globe/ WASHINGTON June 23, 2007 -- The US Senate yesterday hammered out a long-awaited bill that paves the way for generic versions of the world's most expensive drugs, while providing a 12-year financial cushion for local biotechnology leaders who worry that such lower-priced drugs would hurt sales of their name-brand products. ... The compromise bill unveiled yesterday represents a delicate balancing act, said Senator Edward M. Kennedy , Democrat of Massachusetts .
Click here to read full article (www.boston.com)...
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/Orange Book Blog/ June 23, 2007 -- Aaron Barkoff lists recent news stories of interest......
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/Times News Network/ June 23, 2007 New Delhi -- French pharma major, Sanofi-Aventis, has filed a lawsuit in the US District Court of New Jersey challenging Dabur Pharma Limited’s Para-1V filing for marketing the generic versions of Eloxatin, an injectible used in treatment of bowel cancer, in the US. Sanofi-Aventis has alleged that Dabur Pharma’s applications infringe a number of its patents.
Click here to read full article (economictimes.indiatimes.com)...
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/Patent Docs/ In this week: Teva v. Zentiva (carvedilol); Sanofi-Aventis v. Dabur & Teva (oxaliplatin); Abbott v. Impax (divalproex);...
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/Times News Network/ 25 Jun, 2007 NEW DELHI -- Domestic drug majors generally focus on 'branded generics' (cheaper versions of innovator companies, sold with brand names) for higher profit margins, in foreign markets. But this is not so in some of the developed markets of UK and France. In these markets, companies are reversing their strategy...
Click here to read full article (timesofindia.indiatimes.com)...
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PRINCETON, N.J., June 25 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that it officially launched Pravastatin Sodium 80 mg Tablets into the U.S. healthcare system....
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WOODCLIFF LAKE, N.J., June 25 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the United States Supreme Court has denied the plaintiffs' petitions for review of the Second Circuit's decision in Barr's favor in the Tamoxifen Citrate antitrust lawsuits. The Court's ruling ends the antitrust litigation over the 1993 settlement of patent litigation between Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., and AstraZenca....
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PITTSBURGH, June 25 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base), and Ondansetron Orally Disintegrating Tablets (ODT) USP, 4 mg and 8 mg....
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/Motley Fool/ June 25, 2007 -- Generic drug maker Dr. Reddy's Laboratories (NYSE: RDY) is taking a big risk -- and I love the move. It's planning to spend $20 million to increase the number of generic biologics it makes, adding one a year for the next eight years. Currently, there is no abbreviated review process for generic biotech drugs to get FDA or European approval, and therein lies the risk: Dr. Reddy's is developing products for which a global market doesn't exist yet... Click here to read full article (www.fool.com)
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NEW YORK, June 25 (Reuters) - Wyeth said on Monday it asked a New Jersey federal court to stop Teva Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries Ltd. from launching generic forms of its Protonix ulcer drug... Click here to read full article (www.reuters.com)...
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JERUSALEM-- (BUSINESS WIRE) Jun 26, 2007 -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Applications (ANDA) to market Ondansetron Hydrochloride Tablets, 4 mg, 8 mg and 24 mg and Ondansetron Orally Disintegrating Tablets USP, 4 mg and 8 mg. Teva has commenced shipment of these products....
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WOODCLIFF LAKE, N.J., June 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Wyeth Pharmaceuticals Inc.'s Effexor(R) (Venlafaxine Hydrochloride) Tablets...
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/Orange Book Blog/ June 26, 2007 -- After several previous bills went nowhere, lawmakers may have finally reached a viable compromise on follow-on biologics legislation. Last Friday, a bipartisan group of Senators led by Ted Kennedy (D-MA) and Orrin Hatch (R-UT) announced an agreement on a new bill that would establish an abbreviated pathway for FDA approval of biologic drugs. ...
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/Patent Baristas/ June 26th, 2007 -- Senators Kennedy, Hatch, Clinton, and Enzi announced legislation authorizing the FDA to approve a follow-on version of biologic therapies. The legislation, the Biologics Price Competition and Innovation Act of 2007, includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company....
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MORRISTOWN, N.J., June 26 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has launched NIFEdipine extended-release tablets. Distribution of the product will commence immediately....
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/BioPharm Reporter/ 26/06/2007 -- A European regulatory committee has recommended the approval of three generic versions of Johnson & Johnson's (J&J;) anaemia blockbuster Eprex in what could lead to the market launch of new "biosimilars" by the end of the year. ... the three follow-on biologic drugs have been shown to be similar to Eprex, which is marketed as Procrit in the US by Ortho Biotech Products, a J&J; subsidiary. Click here to read full article (www.biopharma-reporter.com)
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Hyderabad, June 26, 2007 -- Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the USFDA for Quinapril Hydrochloride and Hydrochlorothiazide tablets 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg. With this, Aurobindo’s product basket for the USA market has gone up to forty five....
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/Orange Book Blog/ June 27, 2007 -- MarketWatch.com is reporting this afternoon that the Senate Committee on Health, Education, Labor and Pensions has voted in favor of the Biologics Price Competition and Innovation Act of 2007. It is unclear whether the Committee amended the bill before voting on it. The bill will now move to the Senate floor....
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/Patent Baristas/ June 27th, 2007 -- While not as fundamentally important as "Bong Hits 4 Jesus", the U.S. Supreme Court declined to hear a case profoundly important to the pharmaceutical industry. For the second time, the Court rebuffed a challenge to a “reverse payments” deal — this one where an AstraZeneca company paid off a Barr Pharmaceuticals company to delay marketing of generic tamoxifen....
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JERUSALEM-- (BUSINESS WIRE) Jun 28, 2007 -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s ANDA for Famciclovir Tablets, 125 mg, 250 mg and 500 mg. Final approval of this application is anticipated on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to this application....
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/Orange Book Blog/ June 28, 2007 -- Takeda Chem. Indus. et al. v. Alphapharm et al., No. 06-1329 (Fed. Cir. 2007) - In an opinion released today, the Federal Circuit affirmed the validity of Takeda's U.S. Patent No. 4,687,777, which covers pioglitazone HCl (among other compounds)....
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/Patent Baristas/ June 28th, 2007 -- In a long-awaited — and some would say long-feared — update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory and legal issues involved in bringing generic biologics to the marketplace....
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NEW YORK, June 28 (Reuters) - Momenta Pharmaceuticals Inc. said on Thursday a U.S. review of its application to sell a generic version of Sanofi-Aventis' big-selling Lovenox blood-thinner is taking longer than it previously projected...
Click here to read full article (www.reuters.com)...
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/India Infoline News Service/ Mumbai Jun 28, 2007 -- Glenmark Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd. and Natco Pharma Ltd. have received approval from the US Food and Drug Administration (USFDA) for Ondansetron Hydrochloride tablets. ... Meanwhile, Pliva, Sandoz, Kali Labs, Mylan Pharma and Teva Pharma ... Apotex ... KV Pharma... Click here to read full article (www.indiainfoline.com)...
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/BioPharma Reporter/ 28/06/2007 -- A victory of sorts was won yesterday for those who are championing for a regulatory pathway for the US Food and Drug Administration (FDA) approval of follow-on biologics. The US Senate health committee voted unanimously in favour of a draft compromise proposal for the pathway, released last week, called 'The Biologics Price Competition and Innovation Act of 2007'. While still good news for its proponents, the victory is muted, because after all, it is only a compromise bill... Click here to read full article (www.biopharma-reporter.com)...
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LONDON, June 29 /PRNewswire-FirstCall/ -- The Bank of New York, a leading global provider of securities servicing, has been appointed by Teva Pharmaceutical Industries Ltd, which specializes in the development, production and marketing of generic and proprietary branded pharmaceuticals, to act as global custodian and investment accountant for its proprietary assets....
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JERUSALEM, Israel-- (BUSINESS WIRE) Jun 29, 2007 -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s ANDA for Amlodipine Besylate Tablets, 2.5 mg, 5 mg and 10 mg. Shipment of the product will begin shortly....
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/Orange Book Blog/ Pharma News Briefs - June 29, 2007 - collected by Aaron Barkoff...
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BOCA RATON, Fla., June 29 /PRNewswire/ -- Breckenridge announced that it has entered an agreement with Chemo/Liconsa (Madrid, Spain) to develop and manufacturer terbinafine, generic version of Lamisil(R) tablets....
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Mumbai, June 29, 2007: Glenmark Pharmaceuticals Ltd. [Glenmark], a research-based pharmaceutical company, headquartered in Mumbai (India), has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base) and Ondansetron Orally Disintegrating Tablets 4mg & 8mg...
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