Generics Industry News Search
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May 2006 News Archive |
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JERUSALEM--(BUSINESS WIRE)--May 1, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Columbia has granted Teva's motion for summary judgment on the issue of whether Ivax's Abbreviated New Drug Application (ANDA) to market a generic version of Merck's Zocor(R) (Simvastatin) Tablets, 10, 20, and 40 mgs is entitled to 180-day Hatch-Waxman statutory exclusivity. The Court found unlawful the FDA's October 24, 2005 decision denying Ivax's citizen's petition on the exclusivity issue and, accordingly, has remanded the matter back to the FDA....
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Joint Venture Partner to Provide $31 Million in Funding; AlphaRx to Receive 30% Stake and 5% Royalty on Gross Sales
MARKHAM, ON -- (MARKET WIRE) -- 05/01/2006 -- AlphaRx Inc., an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, announced today that its wholly owned subsidiary, AlphaRx International Holdings Limited (AIH), has entered into a Joint Venture Agreement, (JV) with a leading Chinese marketing company (the China Party), to establish a Joint Venture Company (JV Company) in China, for the purpose of manufacturing, marketing and distributing AIH's proprietary line of pharmaceutical and consumer health (over-the-counter) products in Asia....
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Akorn, Inc. today announced that it has signed a definitive agreement with Fidia Farmaceutici S.p.A., a privately-held pharmaceutical company located in Abano Terme (Padova), Italy, to develop four ANDA drug products. The two companies had previously signed a Letter of Intent on October 13, 2005, to develop these four drugs....
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Mumbai, May 02, 2006: Glenmark Pharmaceuticals Inc., USA, the wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. signed a supply and marketing agreement with Lehigh Valley Technologies, Inc. for the manufacturing and marketing of two liquid generic pharmaceutical products [12 SKUs] for the US market. These products which target the pain management therapeutic segment and are controlled substances have a cumulative market size of about USD 46 Mn [IMS] and have limited competition....
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Greg Perry, speaking today in Bucharest, reminded EU Accession Countries to be wary of attempts to have them create obstacles to the production of generic medicines when adapting their legislation to the acquis communautaire....
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CORONA, Calif. and FORT LAUDERDALE, Fla., May 3 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. and Andrx Corporation today announced that they have each received a request for additional information from the Federal Trade Commission (FTC) in connection with Watson's pending acquisition of Andrx....
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HAYWARD, Calif.--(BUSINESS WIRE)--May 3, 2006 - IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Colestid(R) (Colestipol Hydrochloride for Oral Suspension USP) 5 g Packet and 5 g Scoopful....
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NEW YORK, May 03, 2006 /PRNewswire/ -- With numerous blockbuster drugs having lost their patents in the last few years, and more than 30 set to experience similar fate during the next four years, sales of prescription generic drugs are expected to soar past 2005 sales of $28.2 billion to reach upwards of $48 billion in 2010....
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WOODCLIFF LAKE, N.J., May 4, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., today announced that it is challenging the patents protecting Aventis Pharmaceuticals, Inc.'s NASACORT(R) AQ (Triamcinolone Acetonide) Nasal Spray. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for NASACORT AQ....
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In Breckenridge Pharmaceutical, Inc. v. Metabolite Laboratories, Inc., the Federal Circuit summarized the standard for personal jurisdiction in patent cases.
Metabolite holds patents for a method of controlling hyperhomocysteinemia, a condition involving elevated serum metabolite levels, which is an emerging risk factor for heart and vascular disease, and its principal business involves licensing its patents to pharmaceutical manufacturing companies....
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Jerusalem, Israel, May 7, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for their ANDA for Polyethylene Glycol 3350 NF for Oral Solution, 17 gram/scoopful....
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On 2 May 2005, Mr Justice Pumfrey of the UK High Court (Patents Court) handed down this interesting interlocutory decision in Baxter v Abbott [2006] EWHC 919 (Pat).
Take home
This is the latest round of global litigation concerning Abbott’s Ultane (Sevoflurane) anaesthetic. The proceedings were commenced by Baxter for a Declaration of Non-Infringement in respect of Abbott’s patent EP (UK) 0 967 975. Abbott sought better particulars of Baxter’s Product and Process Description (‘PPD’)....
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May 08, 2006, Mumbai: Glenmark Pharmaceuticals Inc., USA [GPI], the wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. [India] [Glenmark] signed a supply and marketing agreement with Aspen USA, Inc. [Aspen] for the joint manufacturing and marketing of three generic controlled-substance pharmaceutical products for the US market. These solid-dose formulation products which target the pain management therapeutic segment have a cumulative market size of about USD 44 Mn [IMS] and have limited competition....
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The latest newsletter from the team at Steinhauser Hoogenraad foreshadows some interesting developments in the Netherlands from 1 July 2006.
Take home
Factors including relatively low cost and good prospects of success have meant that the Netherlands is one of the most popular jurisdictions in which to enforce IP rights. The latest round of amendments to the civil procedure will support this trend. They include:
1. Exp parte interim injunction proceedings....
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CORONA, Calif., May 9, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that it has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--May 9, 2006--Akorn, Inc. today announced that it has signed a commercial manufacturing supply agreement with X-Gen Pharmaceuticals for the product, Neomycin and Polymyxin B Sulfates Solution for Irrigation USP.
X-Gen's Neomycin and Polymyxin B Sulfates Solution for Irrigation USP was recently approved as an Abbreviated New Drug Application (ANDA) by the United States Food and Drug Administration (FDA). Akorn's Decatur, IL manufacturing facility, with capabilities to produce sterile injectables, ophthalmics, and lyophilized pharmaceuticals, is the approved manufacturing site for this product....
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WOODCLIFF LAKE, N.J., May 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has been sued by Eli Lilly & Company, which initiates Barr's challenge of a patent protecting Eli Lilly's Prozac(R) Weekly(TM) (Fluoxetine Hydrochloride) Capsules, USP 90 mg from generic competition....
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LONDON, May 12, 2006 /PRNewswire/ -- Therapeutic Proteins, Ltd. has developed generic versions of filgrastim, interferon and erythropoietin, drugs whose branded versions collectively generate approximately $17 billion in annual revenue worldwide....
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PHILADELPHIA (MarketWatch) -- Merck & Co. Inc. has asked a federal judge to set aside Teva Pharmaceutical Industries Ltd.'s victory in a patent fight involving once-weekly forms of the osteoporosis treatment Fosamax....
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Tenofovir Patent Would Set Dangerous Precedent for Global Access to Newer Essential Medicines
New Delhi, May 12, 2006 – The medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is today expressing its support for Indian civil society groups in their battle against a patent application by Gilead Sciences for the key AIDS drug tenofovir (tenofovir disoproxil fumarate, TDF)....
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Represents Fourth Strength in Company's Claravis(TM) Product Line
WOODCLIFF LAKE, N.J., May 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received approval from the U.S. Food & Drug Administration (FDA) for its application to manufacture and market Isotretinoin Capsules USP, 30 mg. The Company will launch the product immediately under the tradename Claravis(TM). The Company will now market the full line of Isotretinoin product strengths, including Claravis 10 mg, 20 mg, 30 mg and 40 mg capsules....
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WOODCLIFF LAKE, N.J., May 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that Duramed Pharmaceuticals, Inc. has received a Non-Final Rejection notice from the Patent and Trademark Office (PTO) regarding its application for reissue of U.S. Patent 5,898,032 ('032) relating to its SEASONALE(R) extended-cycle oral contraceptive....
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Roche has truncated its attempt to defend the patent on Dilatrend following a settlement with Alphapharm. More details will follow once they become available....
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Pliva, the Croatian generic drugs company, yesterday said it was close to drawing up a shortlist of bidders.
The group effectively put itself up for sale after receiving an unsolicited approach from Actavis, a rival Icelandic generics producer that valued the group at $1.6bn.
Actavis later revised its offer to $1.85bn after being rebuffed by Pliva, which claimed the price tag did not reflect the value within the group....
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MONTREAL, May 11 /CNW Telbec/ - The Canadian Generic Pharmaceutical Association (CGPA) released the results of a study today on the economic impact of the Québec generic drug industry, which indicate a contribution of more than $1 billion to the economy. According to the study conducted by Stratem Inc., the direct and indirect annual contribution of generic drugs breaks down as $287 million in salaries, $507 million in the purchase of goods and services, and $400 million in savings for the healthcare system....
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Injunction stops River's Edge from selling generic version of DUSA’s Nicomide®
Wilmington, MA. May 15, 2006 - DUSA Pharmaceuticals, Inc. announced today that the United States District Court in Trenton, N.J., issued a preliminary injunction against River's Edge Pharmaceuticals LLC enjoining the company from selling its niacinamide formula drug as a generic substitute for Nicomide®, a patented product of DUSA’s....
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Aspen (APN), South Africa’s largest listed pharmaceutical company, today announced that it has reached an agreement with Roche to produce a generic version of oseltamivir for Africa. This complements Roche’s continued efforts to increase and speed up availability of the medicine for world wide influenza pandemic planning. The agreement focuses on providing oseltamivir for pandemic use to further help to address the needs of governments and other not for profit organisations in the African sub - continent....
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PHOENIX, May 17, 2006 (PRIMEZONE) -- Synovics Pharmaceuticals, Inc., a specialty pharmaceutical company with proprietary drug formulation and delivery technologies utilized in the development of a pipeline of difficult to formulate, oral controlled-release generic and branded drugs, announced today that its generic drug development and marketing subsidiary, Synovics Laboratories, Inc., has obtained ownership of an Abbreviated New Drug Application (ANDA) filed with the FDA for an Extended Release (XR) 500mg dosage of Metformin as part of an ANDA transfer and licensing agreement with Nostrum Pharmaceuticals, Inc....
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Jerusalem, Israel, May 17, 2006 - Teva Pharmaceutical Industries Ltd. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for once-daily AZILECT® (rasagiline tablets) as a treatment for Parkinson's disease both as initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease. AZILECT® will become available in the U.S. within 8 to 10 weeks....
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Amgen has filed a complaint for declaratory judgment of patent invalidity and non-infringement in the United States District Court for the District of Delaware (Amgen et al. v. Ariad Pharmaceuticals). Amgen is seeking a declaratory judgment that each of the claims contained in U.S. Patent No. 6,410,516 ('516 Patent) covering methods of treating human disease by regulating NF-?ß cell-signaling activity are invalid and that Amgen and its affiliated entities have not infringed any claims of the '516 Patent based on activities related to the products, Enbrel(R) and Kineret(R)....
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Basingstoke, UK and Philadelphia, US – May 18, 2006 – Shire plc announces that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the U.S. District Court for the District of New Jersey against Corepharma LLC for infringement of Shire Laboratories’ U.S. Patent Nos. 5,326,570 (“‘570 Patent�) and 5,912,013 (“’013 Patent�)....
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PLIVA d.d. announced today that its US subsidiary PLIVA, Inc. has entered into a Product Development, Manufacturing and Supply Agreement with Unichem Laboratories Limited of India....
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ROCKVILLE, Md., May 17, 2006-The Food and Drug Administration (FDA) today announced the tentative approval of generic abacavir sulfate tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief....
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WASHINGTON, May 19 (Reuters) - The first generic rival to Abbott Laboratories Inc.'s antibiotic Omnicef won U.S. approval on Friday, the Food and Drug Administration said in a statement on its Web site....
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Press Release - US Attorney - LAWFUEL - Press Release Network - R. Alexander Acosta, United States Attorney for the Southern District of Florida, announced today that the United States has intervened in a whistleblower suit filed against Abbott Laboratories Inc., alleging that the company violated the False Claims Act. In its complaint, the government alleges that Abbott—a pharmaceutical manufacturer that sells brand and generic drugs that are reimbursed by the Medicare and Medicaid programs—engaged in a scheme to report fraudulent and inflated prices for several pharmaceutical products, knowing that federal healthcare programs established reimbursement rates based on those reported prices....
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On 19 May 2006, Mr Justice Pumfrey of the UK High Court (Patents Court) handed down his decision in Mayne Pharma v Debiopharm SA & Sanofi-Synthélabo [2006] EWHC 1123 (Pat).
Take home
Mayne Pharma had sought revocation and declarations of non-infringement in relation to EP0943331 and EP1308454 owned by Sanofi and Debiopharm respectively. Both patents were held not-infringed and revoked. An important aspect of the case was the nature of the skilled addressee of the patents and the testimony given by expert witnesses for each side....
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Acambis, a UK biotechnology company, is fighting a patent-infringement lawsuit that may bar it from a $1.9bn contract to provide smallpox vaccines to the US government. Acambis is bidding for a US Government contract to supply an emergency-use stockpile of MVA.
Currently, the company is fighting a three-front battle with Danish vaccine maker Bavarian Nordic, which alleges that Acambis' MVA vaccine infringes its treatment, which is based on the same smallpox strain....
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Jerusalem, Israel, May 22, 2006 - Teva Pharmaceutical Industries Ltd. 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 Forest Laboratories, Inc.'s Lexapro® (Escitalopram Oxalate) Tablets, 5 mg, 10 mg and 20 mg....
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PHILADELPHIA--(BUSINESS WIRE)--May 22, 2006 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) for Probenecid Tablets 500 mg, USP....
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Aurobindo Pharma is proud to announce that the US FDA has granted tentative approval for Abacavir Sulfate Tablets 300 mg (base). This is the first generic version approval given by US FDA.
The aforesaid product will now be available for consideration for purchase under the PEPFAR. Aurobindo manufactures both API and formulation for this generic....
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Drug maker Cipla Ltd has received tentative approval from the US Food and Drug Administration for generic AIDS drug nevirapine in the tablet form, according to an FDA statement. Also, Sun Pharma Ltd has received tentative approval for ondansetron in the injection form....
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TORONTO, ONTARIO--(CCNMatthews - May 23, 2006) - Orbus Pharma Inc., today announces the successful results of the most demanding phase of the bioequivalence studies in its European drug development of a once per day formulation for metoprolol succinate extended release (XR) tablets. Metoprolol succinate is the world's leading cardioselective beta-blocker for hypertension, angina pectoris, heart failure, disturbances of cardiac rhythm including especially supraventricular tachycardia, maintenance treatment after myocardial infarction and functional heart disorders with palpitations and for migraine prophylaxis. The Orbus XR formulation is a generic version of Astra Zeneca's Beloc-ZOK® (metoprolol CR/XL) which has reported 2005 annual sales of US$1.735 billion....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--May 24, 2006 - Akorn, Inc. today announced that it has received an ANDA approval for Orphenadrine Citrate Injection USP. The product will be manufactured in the Decatur, IL Facility, and is expected to be launched in the third quarter 2006....
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MELVILLE, N.Y., May 24, 2006 /PRNewswire/ -- Today, specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc., announced it is first-to-market with FDA-approved Metronidazole Lotion 0.75% (Rx). This product is AB-rated to MetroLotion(R) by Galderma and is indicated for the treatment of rosacea (see product package insert for full prescribing information). Metronidazole Lotion is available in a 59 ml (2 oz.) bottle....
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Research and Markets (http://www.researchandmarkets.com/reports/c37532) has announced the addition of the Espicom Business Intelligence report The Pharmaceutical Market: Canada to their offering....
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ST. LOUIS, May 24 /PRNewswire-FirstCall/ -- For millions of Americans, getting a new prescription increasingly means first trying a lower cost generic medicine before using a more expensive brand drug.
Today, Express Scripts reported that 14 million consumers in pharmacy benefit plans it manages are now covered by programs that support using a generic as a first treatment option....
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PITTSBURGH, May 24 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. Sumatriptan Succinate Tablets are indicated for the acute treatment of migraine headaches. They are the generic version of GlaxoSmithKline's Imitrex® Tablets, which had annual U.S. sales of approximately $878 million as of March 31, 2006....
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Jerusalem, Israel, May 25, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Ivax Abbreviated New Drug Application (ANDA) for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg....
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Woonsocket, RI (May 25, 2006) - Onset Therapeutics, a specialty pharmaceutical company that focuses on the development and commercialization of innovative, patent protected topical products for skin and wound related disorders, announced today that they have signed an Agreement with Granard Pharmaceutical Sales and Marketing to provide trade sales & marketing services. Granard will be responsible for contracting with pharmaceutical wholesalers, retail pharmacy chains, and mail order pharmacies and implementing product related promotional programs with this customer segment....
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BALTIMORE, May 26 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cefdinir Capsules, 300 mg....
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Jerusalem, Israel, May 28, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's antihypertensive agent Cozaar® (Losartan Potassium) Tablets, 25 mg, 50 mg and 100 mg. Final approval of this ANDA is expected in April 2010 when patent protection for the brand product expires....
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Actavis is one of the first to launch three new generic products into a number of key European markets including Germany, the UK, Hungary and Poland. The drugs include Sumatriptan, used to treat migraine headaches, the atypical antipsychotic Risperidone and Granisetron, the anti-nausea drug....
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STADApharm GmbH, a wholly-owned subsidiary of STADA Arzneimittel AG, announced today, on May 30, 2006, comprehensive price reductions on numerous products in its generics portfolio in the German market as of July 1, 2006. It is thus expected that over 550 pharmacy retail prices for more than 110 active ingredients will be reduced by up to more than 50%. The price reductions thereby affect more than 50% of STADApharm’s portfolio of prescription-only active ingredients....
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Take home
This is one for those in the pharmaceutical industry and an interest in the USA. It has potentially enormous implications for strategy in this industry in the US, and about zero application otherwise.
The FDA has appealed summary judgment at first instance (Ranbaxy v Leavitt, 30 April 2006 - Federal District court for the District of Columbia) which held that it should have re-listed Merck’s Zocor (simvastatin) patents in the Orange Book in response to citizen’s petitions filed by Ivax (now part of Teva) and Ranbaxy in 2005....
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• US approval a breakthrough in goal of making high-quality and cost-effective follow-on biotechnology medicines available for patients
• Omnitrope now approved for treatment of growth disorders in children and adults in the US, the European Union and Australia
• Sandoz committed to bringing other follow-on biotechnology medicines to patients worldwide following patent expiry...
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The U.S. Food and Drug Administration has approved Novartis AG's Omnitrope hormone in would could mark a sea change in the stance taken by the FDA on generic biotechnology drugs. This precedent setting event marks the first follow-on version of a previously approved recombinant biotechnology drug in the U.S....
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Patents are available only for inventions that are novel, non-obvious as well as useful. Therefore, where novelty is a bedrock concept of all patent systems, nonobviousness is the ultimate condition of patentability but first of all an invention i.e. a product of investigation and experiment must qualify as an invention....
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