Generics Industry News Search
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August 2007 News Archive |
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/Orange Book Blog/ August 01, 2007 -- The Federal Circuit decided an unusual case yesterday respecting Somerset Pharmaceuticals' application for an interim patent term extension for U.S. Reissue Patent No. RE 34,579. The '579 patent covers a method of treating depression using Emsam, a transdermal patch that includes selegiline as the active ingredient....
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/Patently-O Blog/ Aug 01, 2007 -- In 2005, the District of Columbia (DC) adopted a set of legislation to reduce prescription drug costs. In particular, the law would bar a manufacturer from placing minimum retail price restrictions or from charging “excessive prices.” The two major innovator pharmaceutical organizations quickly sued and won a ruling that the law was unconstitutional ...
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JERUSALEM--(BUSINESS WIRE)--Aug 2, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix(R) (Pantoprazole Sodium) Delayed Release (DR) Tablets, 20 mg and 40 mg....
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LOS ANGELES--(BUSINESS WIRE)--Aug 2, 2007 - LOS ANGELES--(BUSINESS WIRE)--Aug 2, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that its hospital-based products business, Abraxis Pharmaceutical Products (APP), has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Caffeine Citrate injection, USP, 20 mg/mL, the generic equivalent of Cafcit(R) Injection manufactured by Mead Johnson and Company. BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that its hospital-based products business, Abraxis Pharmaceutical Products (APP), has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Caffeine Citrate injection, USP, 20 mg/mL, the generic equivalent of Cafcit(R) Injection manufactured by Mead Johnson and Company....
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PRINCETON, N.J., August 02, 2007 /PRNewswire/ -- Sandoz introduced metoprolol succinate 50 mg extended release tablets, a generic equivalent of Toprol XL(R), in the U.S. today. Metoprolol succinate 50 mg ER is a beta-blocker used to treat angina, heart failure, and high blood pressure....
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WASHINGTON, Aug. 2 /PRNewswire-USNewswire/ -- A key benchmark of plan performance -- the use of generic medications -- is higher in Medicare Part D than in the rest of the marketplace, according to a new report from IMS Health, a global pharmaceutical and healthcare consulting firm....
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/Patent Docs/ August 02, 2007 -- On remand from the Federal Circuit (see "Impax Labs., Inc. v. Aventis Pharm. Inc. (Fed. Cir. 2006)"), the District Court found that U.S. Pat. No. 5,527,814 is not anticipated by the prior art. Particularly, the Court found that the anticipating reference cited by Impax does not enable one of skill in the art to use rizulole to treat amyotrophic lateral sclerosis (ALS)....
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WASHINGTON, Aug. 2 /PRNewswire-USNewswire/ -- A key benchmark of plan performance -- the use of generic medications -- is higher in Medicare Part D than in the rest of the marketplace, according to a new report from IMS Health, a global pharmaceutical and healthcare consulting firm. Part D plans have also helped previously uninsured seniors to reduce their out-of-pocket costs by 60 percent per prescription according to IMS, said the Pharmaceutical Care Management Association (PCMA) today....
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/Patent Baristas/ August 2nd, 2007 -- On Remand from the Supreme Court, the U.S. Court of Appeals for the Federal Circuit applied the broad scope of the research exemption to the Integra case and reversed the district court’s judgment of infringement. Integra Lifesciences v. Merck KGaA (02-1052-1065)....
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WOODCLIFF LAKE, N.J., August 03, 2007 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced it had begun shipping metoprolol succinate extended release 50 mg tablets. As previously announced, in November 2006 Par entered into a supply and distribution agreement with AstraZeneca in the U.S. to distribute metoprolol succinate extended release tablets, which is substitutable for AstraZeneca's TOPROL-XL(R) extended release tablets. Par began shipping 25 mg tablets of generic Toprol-XL at that time....
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BOCA RATON, Fla., August 03, 2007 /PRNewswire/ -- Breckenridge announced today that it has entered into an agreement with PII (Pharmaceutics International. Inc.), Hunt Valley, MD to develop and manufacture a generic HRT product. Breckenridge filed an ANDA with the FDA in early 2006 and expects to receive FDA Approval and market the product in 2007....
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/Orange Book Blog/ August 03, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Patent Baristas/ August 3rd, 2007 -- In a follow-up on our earlier discussion regarding the Supreme Court’s broad scope of the research exemption to the Integra case, the question came up asking if a patented delivery formulation — say, a sustained release formulation as opposed to a therapeutic itself — would fall within the exemption from infringement under the Food and Drug Administration (”FDA”) Exemption......
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/IPKat blog/ 03 August 2007 -- Now here's a mysterious case - a major pharma company goes to a good deal of trouble to secure patent protection for an invention, eventually gets it and then decides - for reasons unexplained - to scrap the designation of the United Kingdom. Arrow Generics Ltd and another v Merck & Co Inc [2007] EWHC 1900 (Ch) was a decision of Mr Justice Kitchin in the Patents Court on 31 July. The full text of the judgment is happily available on BAILII....
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/Patent Docs/ August 05, 2007 -- 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 - Astrazeneca AB v. Dr Reddy's (Omeprazole)...
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LOS ANGELES, Aug. 6 /PRNewswire-USNewswire/ -- AIDS Healthcare Foundation (AHF), which operates free AIDS treatment clinics in India (Mysore, New Delhi and in Guwahati, Assam in collaboration with the National AIDS Control Organization) today applauded the news that an Indian court rejected a legal challenge mounted by the Swiss pharmaceutical company Novartis to a portion of India's Patent Act that restricts certain kinds of patents, a ruling that will protect access to affordable medicines in the developing world. ...
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/Orange Book Blog/ August 06, 2007 -- Recent updates to the Hatch-Waxman Tracker maintained by Aaron Barkoff of the Orange Book Blog....
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SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (Nasdaq: SNTS), a specialty pharmaceutical company, today announced that it and its licensor, the University of Missouri, have received a Paragraph IV Certification Notice from Par Pharmaceutical, Inc. advising of the submission of an Abbreviated New Drug Application (ANDA) for omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg and 40 mg/1100 mg....
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LIBERTY CORNER, N.J., August 08, 2007 /PRNewswire/ -- GeneraMedix Inc. has launched Fosphenytoin Sodium Injection, USP. GeneraMedix offers Fosphenytoin Sodium Injection, USP, 50 mg PE*/mL in 2 and 10 mL vials, preservative free....
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NEW DELHI, Aug. 8 /PRNewswire-USNewswire/ -- As part of its ongoing global campaign to lower drug prices and improve access to lifesaving AIDS treatments worldwide, AIDS Healthcare Foundation (AHF) will host a press conference in New Delhi on Thursday August 9th with several Indian civil society partners and co-sponsors to unveil a print advertisement in a new advocacy campaign that challenges Cipla, the Indian drug maker, for its steep prices for Cipla's generic AIDS drugs in India. AHF and the coalition are well aware that other drug companies including Ranbaxy, Emcure, Aurobindo and Genex are not immune to similar review, which will follow the launch of this initial advertisement focusing on Cipla, the largest company....
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NEW DELHI, Aug. 8 /PRNewswire-USNewswire/ -- As part of its ongoing global campaign to lower drug prices and improve access to lifesaving AIDS treatments worldwide, AIDS Healthcare Foundation (AHF) will host a press conference in New Delhi on Thursday August 9th with several Indian civil society partners and co-sponsors to unveil a print advertisement in a new advocacy campaign that challenges Cipla, the Indian drug maker, for its steep prices for Cipla's generic AIDS drugs in India. AHF and the coalition are well aware that other drug companies including Ranbaxy, Emcure, Aurobindo and Genex are not immune to similar review, which will follow the launch of this initial advertisement focusing on Cipla, the largest company....
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BEDFORD, Ohio, August 09, 2007 /PRNewswire/ -- Bedford Laboratories(TM), a division of Ben Venue Laboratories, Inc., begins shipping Epirubicin HCl Injection and Idarubicin HCl Injection. Epirubicin, an anthracycline cytotoxic agent, is AP rated equivalent to Pfizer's Ellence(R). Idarubicin HCl Injection has AP bioequivalence to Idamycin(R) marketed by Pfizer....
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IRVINE, California, August 9, 2007 – Teva Health Systems is pleased to announce the introduction and availability of Epirubicin Hydrochloride Injection. This product is AP rated to Ellence®* Injection. Epirubicin Hydrochloride Injection is available in 2 mg/mL, 50 mg and 2 mg/mL, 200 mg, in single-dose polymer vials....
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LIBERTY CORNER, N.J., August 09, 2007 /PRNewswire/ -- GeneraMedix Inc. has received FDA approval and has launched Ampicillin and Sulbactam for Injection, USP. This is the first product launched resulting from a long term, multi-product development and supply agreement between GeneraMedix Inc. and MN Pharmaceuticals, a leading pharmaceutical manufacturer based in Turkey.
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ROCKVILLE, Md., Aug. 9, 2007-FDA granted tentative approval on August 8, 2007 for a generic formulation of a combination product, lamuvidine and zidovidine tablets, 150 mg/300 mg, manufactured by Emcure Pharmaceuticals Inc. of Pune, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief...
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Aug. 9 (Bloomberg) -- Sanofi-Aventis SA's Acomplia weight- loss pill, linked to suicide, is becoming popular in generic form in India. That may end the product's chances of ever reaching the U.S., where it has been delayed by regulators. Cipla Ltd. and Ranbaxy Laboratories Ltd. are among six drugmakers exploiting a loophole in India patent laws, selling copies of the medicine under names like Slimona and Defat. The pills are sold without prescription for as little as 12 cents... Click here to read full article (www.bloomberg.com)...
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JERUSALEM, Israel--(BUSINESS WIRE)--Aug 10, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Epirubicin Hydrochloride Injection, 2 mg/mL. Shipment of the product, available in 50 mg/25 mL and 200 mg/100 mL single use vials, will begin immediately....
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JERUSALEM--(BUSINESS WIRE)--Aug 10, 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 Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. Final approval of this product is anticipated upon expiration of patent protection for the brand product in March 2012....
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SCHAUMBURG, Ill.--(BUSINESS WIRE)--Aug 10, 2007 - Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced the approval from the U.S. Food and Drug Administration (FDA) to market Cefotetan Disodium for Injection, the generic equivalent of AstraZeneca's Cefotan(R). ...
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PITTSBURGH, August 10, 2007 /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 Application (ANDA) for Verapamil Hydrochloride (HCl) Extended-release (ER) Capsules (PM), 100 mg, 200 mg and 300 mg....
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/Orange Book Blog/ August 10, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of Orange Book Blog...
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/Patent Docs Blog/ August 12, 2007 -- 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: Eli Lilly v. Actavis (Atomoxetine)...
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BEDFORD, Ohio, August 13, 2007 /PRNewswire/ -- Bedford Laboratories(TM), a division of Ben Venue Laboratories, Inc., announced FDA approval to begin shipping Pentostatin for Injection. This product is AP rated and is equivalent to Nipent(R) by Hospira Inc. Pentostatin is indicated for the treatment of hairy cell leukemia....
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ROCKVILLE, Md., Aug. 13, 2007-FDA, on August 13, 2007, granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Hetero Drugs Limited, Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR)....
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DETROIT, August 13, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Repaglinide Tablets USP (repaglinide), 0.5mg, 1mg and 2mg....
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ESPOO, Finland, Aug. 13, 2007-Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed with the U.S. Food and Drug Administration (FDA) by a generic drug company seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States....
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REYKJAVIK, Iceland, August 13, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Propranolol Hydrochloride extended-release capsules. Distribution of the product will commence immediately....
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IRVINE, Calif., Aug. 13, 2007-Teva Health Systems announces the introduction and availability of Doxorubicin Hydrochloride Injection, USP. This product compares to Adriamycin PFS....
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/Orange Book Blog/ American Conference Institute's popular "FDA Boot Camp" returns to the University of Chicago's Gleacher Center in downtown Chicago on September 25-26. ACI expects a sell-out of this conference and recommends early registration. The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies. It features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms....
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/Patent Docs Blog/ August 13, 2007 -- Last Friday, The San Francisco Chronicle reported on new challenges facing the biotech industry. In an article by Bernadette Tansey entitled "As biotech patents run out, innovation and competition may thrive," the Chronicle addressed the expiration of key biotech patents, increased competition being applied by generic manufacturers, and new biologics legislation making its way through Congress (although possibly stalled until 2008)....
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/Patent Docs Blog/ August 13, 2007 -- The cost of prescription drugs, and the proper apportionment of these costs between innovator drug companies (who frequently possess patent protection of their products) and consumers (who have access to political and other sources of resistance to increased drug costs) poses a policy problem that has been brewing for a generation. In the U.S., the Federal government has acted to promote the development of a generic drug industry...
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ROCKVILLE, Md., Aug. 14, 2007--FDA, on August 13, 2007, granted tentative approval for a new fixed dose three-drug combination pill containing generic lamivudine, stavudine and nevirapine, to treat human immunodeficiency virus (HIV-1) infection in children outside the United States. This is the first combination of its kind available to meet the needs of children less than 12 years of age, and represents a major advance in global AIDS treatment efforts. The generic combination drug tablet is manufactured by Cipla Limited, of Mumbai, India....
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/Patent Baristas/ August 14th, 2007 -- As further evidence that the United States Patent and Trademark Office (Office) hates the chemical/pharma/biotecch arts, the Office is proposing to revise the rules of practice pertaining to any claim using alternative language to claim one or more species. That is, if the claims use Markush or other forms of alternative language. ...According to the USPTO, the search and examination of such claims consume a disproportionate amount of Office resources as compared to other types of claims....
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/Patent Docs Blog/ August 14, 2007 -- The effects of the global crisis in patented drug pricing were evident recently in two actions (or inactions) in the European Union. In the first, the Committee on International Trade of the European Parliament delayed voting on the Trade Related Intellectual Property Rights protocol promulgated by the World Trade Organization (WTO). This (in)action was taken over a dispute regarding the role Europe will play in facilitating delivery of "essential" medicines to developing countries. ...
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/Moneycontrol.com/ 2007-08-14 -- India's pioneering pharmaceuticals entrepreneur, Dr Anji Reddy talks about the cutting edge research happening at Dr Reddy's Labs. Excerpts from an interview given to CNBC-TV18 Q: Of some of your other ambitious and exciting research projects one is RCT (Reverse Cholesterol Transport), also there is a lot of progress and you are also working on a atherosclerosis drug, could you briefly tell us about those particular projects?...Click here to read full article (www.moneycontrol.com)...
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WOODCLIFF LAKE, N.J., Aug. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Warner Chilcott (US), Inc. in connection with Warner Chilcott's Femcon(R) FE (norethindrone and ethinyl estradiol) chewable oral contraceptive. ...
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HAMILTON, Bermuda, August 15, 2007 /PRNewswire-FirstCall/ -- Warner Chilcott Limited announced today that it has received a Paragraph IV Certification Notice from Barr Laboratories, Inc. ("Barr") advising the Company of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of FEMCON FE....
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/Frost & Sullivan/ August 15, 2007 PALO ALTO, Calif.--(BUSINESS WIRE)--With several major blockbuster drugs reaching patent expiry, the market for generic pharmaceuticals in the United States is booming and is set to witness significant growth over the next few years. Demand for lower healthcare costs and pressure from payers to increase the use of generics are also major drivers for this market as these drugs are considerably less expensive than the blockbuster drugs developed by branded pharmaceutical companies....
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/Motley Fool/ By Brian Orelli August 15, 2007 -- In a sector where big is almost always better and companies swallow rivals that are twice their size, one small generic-drug maker has done quite well over the last year. With revenues of just $117 million in its last fiscal year, Caraco Pharmaceutical Laboratories (AMEX: CPD) pales in comparison ... But it has been able to grow revenues at a substantial clip, causing its stock to soar more than 50% over the last year. Click here to read full article (www.fool.com)
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/Orange Book Blog/ Informa Life Sciences will be presenting a unique conference entitled "European Pharmaceutical Law Forum" in Washington, D.C., October 23-25. The conference will provide an invaluable introduction to the laws and regulations governing the pharmaceutical, biotech and generics industries in Europe....
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LONDON--(BUSINESS WIRE)--Aug 17, 2007 - Osmetech plc (LSE:OMH), the fast developing international molecular diagnostics business, notes yesterday's announcement by the FDA regarding the approval of updating labelling for the widely used blood-thinning drug, Coumadin, to explain that an individual's genetic makeup may influence how they respond to the drug....
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/Patent Docs Blog/ August 17, 2007 -- Patent Resources Group (PRG) will be offering a course entitled "Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman" on October 25-27, 2007 in Palm Springs, CA. ...
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NEW YORK (CNNMoney.com) August 17 2007 -- Pfizer lost the latest round in a patent battle over the declining blockbuster Lipitor that could be worth $6 billion to the pharma giant. The U.S. Patent and Trademark Office on Thursday rejected Pfizer Inc.'s (up $0.29 to $23.68, Charts, Fortune 500) application to reissue a patent on its cholesterol-cutting drug Lipitor that would extend legal protection to June 2011, said company spokesman Bryant Haskins... Click here to read full article (money.cnn.com)...
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MUMBAI, India, August 18, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s multiple Abbreviated New Drug Applications (ANDAs) for Octreotide acetate injection in vials and ampoules....
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/Patent Docs Blog/ August 19, 2007 -- There have been two distinct stages in the developing world's reaction to the patent-related provisions of the General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that established the World Trade Organization (WTO). The first is illustrated by Article 78 of Brasilian statue 9279/96, the national implementing statute for the TRIPS agreement:...
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/Patent Docs Blog/ August 19, 2007 -- 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: Novartis v. Ranbaxy (valsartan); Eli Lilly v. Actavis (atomoxetine); Aventis v. Mylan (fexofenadine)...
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/Orange Book Blog/ August 19, 2007 -- As The Wall Street Journal reported last week, the U.S. Patent and Trademark Office has issued an initial rejection of Pfizer's application for a reissue patent of U.S. Patent No. 5,273,995--one of two Pfizer patents covering Lipitor....
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PRINCETON, N.J., August 20, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10 mg/325 mg strengths....
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MORRISTOWN, N.J., August 21, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Fentanyl Transdermal System. Distribution of the product will begin immediately....
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CORONA, Calif., August 21, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for fentanyl transdermal system in the 25, 50, 75 & 100 mcg/hour strengths....
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CHESTER, N.J., August 21, 2007 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. today announced that it has received a Paragraph IV Certification Notice letter, advising that Perrigo R&D; Co., has submitted an Abbreviated New Drug Application (ANDA) for guaifenesin 600 mg single-ingredient extended-release tablets....
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Tuesday, August 21, 2007 -- A disturbing recent decision from the Federal Court of Canada, Eli Lilly Canada Inc. v. Novopharm Ltd., calls into question the validity of many patents in the pharmaceutical and chemical fields.1 The decision, which threatens to escape timely appellate review, dramatically alters the patent disclosure requirements in a way that conflicts with global patent practice and Canada’s international treaty obligations. Click here to read full article (www.ipfrontline.com)...
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DETROIT, August 22, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Tablets USP, 37.5 mg (Phentermine HCl)....
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BURLINGTON, ON, Aug. 22 /CNW/ - Boehringer Ingelheim has offered the Canadian generic pharmaceutical manufacturer Apotex Inc. a royalty free, voluntary licence to manufacture and export products containing nevirapine to Rwanda as requested by Apotex. Boehringer Ingelheim has also offered to extend the license to other developing countries as identified by the World Health Organization....
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22-Aug, New Delhi | August 22, 2007: Dabur Pharma (NSE: DABURPHARM, BSE: 532545), India’s leading oncology player, today announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Epirubicin Injection 50mg and 200mg....
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/Patent Baristas Blog/ August 22nd, 2007 -- ...The United States Patent and Trademark Office is continuing its march towards world domination by revising the rules of practice in patent cases relating to continuing applications and requests for continued examination practices, and for the examination of claims in patent applications. ... concern that the rule changes may be especially problematic for the chemical, pharmaceutical and biotech arts. ...
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BANGKOK (Thomson Financial) 08.22.07 - The Thai government said Wednesday it would import generic versions of popular heart disease drug Plavix from India.
'We will start importing the first batch of 2 million Plavix pills,' Vichai Chokvivat, chairman of the state-run drugmaker Government Pharmaceutical Organisation, said in a statement.
Click here to read full article (www.forbes.com)...
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/Outsourcing Pharma/ 23/08/2007 - Novartis is to pull millions of planned investment dollars out of India in reaction to intellectual property (IP) fears. The decision may leave China as the cat that got the cream. In November last year Novartis announced plans to splash its cash in Asia, intending to invest $100m (€79m) in China and INR5bn (€90m) in India to establish large new R&D; centres. ... Things have since gone sour for Novartis in India, who now plans to invest more in countries where it has IP protection. Click here to read full article (www.outsourcing-pharma.com)...
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JERUSALEM--(BUSINESS WIRE)--Aug 24, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Famvir(R) (Famciclovir) Tablets, 125 mg, 250 mg and 500 mg. The brand product had annual sales of approximately $200 million in the United States for the twelve months ended June 30, 2007, based on IMS sales data....
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MUMBAI, India, August 25, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the company's Abbreviated New Drug Application (ANDA) for generic Sinemet CR, an extended release version of carbidopa with levodopa....
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/Patent Docs Blog/ August 26, 2007 -- 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: Medpointe Healthcare Inc. v. Cobalt Pharmaceuticals (Azelastine)...
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JERUSALEM, Israel--(BUSINESS WIRE)--Aug 27, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that, following the expiration of pediatric exclusivity for U.S. Patent No. 4,743,450, the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's hypertension treatment Accupril(R) (Quinapril Hydrochloride) ...
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EDISON, N.J., August 27, 2007 /PRNewswire/ -- Heritage Pharmaceuticals Inc. ("Heritage") and Ipca Laboratories Ltd. ("Ipca") announced today that they have entered in to a strategic alliance for the development, supply and marketing of generic pharmaceutical products for the U.S. prescription drug market. ...
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/Globes Online/ Gitit Pincas 27 Aug 07 11:26 -- In the quarter just ended, it was the at-risk launch of the generic version of Novartis AG 's drug Lotrel which was the joker in the pack that helped Teva Pharmaceutical Industries Ltd. deliver good figures. By the end of the third quarter on September 30 Teva, will have made two more such launches: the generic version of Wyeth's Protonix for the treatment of GERD, and a generic version of Novartis's Famvir, announced at the end of last week. Click here to read full article (www.globes.co.il)
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/Live Mint/ Aug 27 2007 New Delhi -- Nearly a tenth of India’s 93,000 AIDS patients on antiretroviral therapy are said to require drugs similar to Aluvia. - Less than a week after an Indian patent filing made by Abbott Laboratories Inc. for Aluvia, a heat stable version of its $1.14 billion (Rs4,696.8 crore) anti-HIV drug, was challenged by a US non-profit health group, it is becoming clear that the Illinois, US-based drug maker will face several more ‘pre-grant oppositions’ here. Click here to read full article (www.livemint.com)...
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/Express Pharma Online/ 16-31 August 2007 - The Indian pharmaceutical market is today amongst the fastest growing pharma markets across the globe. In 2006, the growth rate in the world pharma market was five percent, while the Indian market growth rate was in the mid-teens. This Indian industry is one of the developing world’s largest and most developed, ranking fourth in the world, in terms of production volume and 13th in domestic consumption value. Over the last 30 years, India’s pharmaceutical industry has evolved from being almost non-existent to a world leader in the production of high quality generic drugs. India has garnered a worldwide reputation for producing high quality, low cost generic drugs. Click here to read full article (www.expresspharmaonline.com)...
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WOODCLIFF LAKE, N.J., August 28, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received approval from the Therapeutic Products Directorate (TPD) of Health Canada for its Abbreviated New Drug Submission (ANDS) for its Portia(R) generic oral contraceptive as a generic equivalent of Wyeth Laboratories' Min-Ovral(R) Tablets....
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THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug 28, 2007 - Amgen (NASDAQ:AMGN) today announced that the U.S. Federal District Court in Boston granted Amgen's motion for summary judgment and ruled that Roche's pegylated-erythropoietin ("peg-EPO") product will infringe Amgen's EPO pharmaceutical composition patent number 5,955,422. In a separate decision yesterday, the Court also granted summary judgment in favor of Amgen on certain Roche defenses against the patents-in-suit....
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/Patent Docs Blog/ August 29, 2007 -- On August 21, 2007, the U.S. Patent and Trademark Office (PTO) released final rules limiting a patent applicant's opportunities to pursue patent protection for a given invention. The PTO rules do this by restricting the number of patent applications that can be filed to the same basic invention to one original application and two continuations or continuations-in-part (CIPs), and by restricting a patent applicant to only a single request for continued examination (RCE) in a patent family. ...
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MUMBAI, India, August 30, 2007- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for generic Razadynetm, galantamine tablets....
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PRINCETON, N.J., August 30, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Galantamine Hydrobromide Tablets, 4mg (base), 8mg (base), and 12mg (base). ...
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/US-Pharmatechnologist/ 8/30/2007 - Pharmaceutical companies are being urged to develop strategies in an effort to deal with the controversial new patent rules that come into force in the US in November. According to Wolf, Greenfield & Sacks law firm associate Roque El-Hayek, MD, pharmaceutical companies need to consider strategies to cope with the patent rule changes which will see the number of submitted applications drastically slashed in a bid to streamline the workload of the United States Patent and Trademark Office (USPTO), but which may have an adverse effect on the pharma industry. Click here to read full article (us-pharmatechnologist.com)...
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Aug. 30 (Bloomberg) -- Ranbaxy Laboratories Ltd., India's second-biggest drugmaker, dropped a bid to sell generic versions of Schering-Plough Corp.'s allergy medicine Clarinex in the U.S. Ranbaxy agreed not to sell Clarinex tablets, Clarinex reditabs that melt on the tongue or Clarinex D-24 extended release tablets taken once a day until the expiration of a patent in 2020, said Schering-Plough spokesman Fred Malley. That agreement will end if another company is successful in challenging the validity of the patent, court records show. Click here to read full article (www.bloomberg.com)...
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HOLZKIRCHEN, Germany, August 31, 2007 - Sandoz has become the first company to develop and receive European Commission approval for its biosimilar epoetin alfa, achieving another important milestone in its efforts to bring high quality, cost-effective biological medicines to patients....
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DETROIT, August 31, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg and 300 mg (Allopurinol)....
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