Generics Industry News Search
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September 2006 News Archive |
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ALLEGAN, Mich., September 01, 2006 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that its Perrigo Israel Pharmaceuticals subsidiary has been granted tentative approval from the U. S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%. The reference listed drug (Olux(R) Foam, 0.05%, Connetics Corporation) is subject to a period of patent protection. Perrigo filed its ANDA with a paragraph IV patent certification stating that the patent is invalid, unenforceable, or will not be infringed under this ANDA....
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NEW YORK, Sept. 1 /PRNewswire-FirstCall/ -- Pfizer Inc said today that a federal court in the Middle District of North Carolina has upheld the company's U.S. patent covering amlodipine besylate, the active ingredient in Norvasc, the world's most-prescribed branded medicine for treating hypertension. The patent had been challenged by the generic manufacturer, Synthon Pharmaceuticals....
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Gent, Belgium - Madison, Wisconsin, USA, September 2, 2006 – 10 AM - In a Patent Infringement Action in The United States District Court for The Western District of Wisconsin, Innogenetics’ HCV Genotyping Patent was found Enforceable, Valid, and Infringed....
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CRANFORD, N.J., September 06, 2006 /PRNewswire/ -. Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group (ICEX: ACT), announced today that it has begun shipping Pilocarpine Hydrochloride 7.5mg tablets to complement Pilocarpine 5mg tablets that the company currently offers....
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HAWTHORNE, N.Y., Sept. 6, 2006 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Extended Phenytoin Sodium Capsules, USP 100mg....
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In a patent battle over the world’s top-selling drug, the U.S. Court of Appeals for the Federal Circuit affirmed a district court holding that a claim cannot be constructed contrary to the specification or construed to import a limitation from the specification. However, the Court reversed part of the district court decision, holding that in order to be valid, a claim must meet all statutory requirements, including § 112, ¶ 4. Pfizer Inc. v. Ranbaxy Laboratories Limited, Case No. 06-1179 (Fed. Cir. Aug. 2, 2006) (Michel, C.J.)....
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WOODCLIFF LAKE, N.J., Sept. 7 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary Barr Laboratories, Inc. is launching a generic version of the Company's proprietary SEASONALE(R) extended-cycle oral contraceptive under the tradename Jolessa(TM). The Company launched its generic version of SEASONALE following the final U.S. Food and Drug Administration (FDA) approval of Watson Laboratories, Inc.'s Abbreviated New Drug Application (ANDA) for SEASONALE. Watson received approval following the expiration of the Company's 3-year New Product Exclusivity on September 5, 2006....
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CORONA, Calif., Sept 07, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), 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 levonorgestrel / ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg....
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- Mylan Plans to Immediately Launch Upon Final FDA Approval -
PITTSBURGH, Sept. 7 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Court of Appeals for the Federal Circuit upheld a district court decision that Myl...
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HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 7, 2006--IMPAX Laboratories, Inc. announced that the U.S. Court of Appeals for the Federal Circuit upheld a lower court ruling in favor of IMPAX in its defense of a lawsuit brought by Alza Corporation, a Johnson & Johnson (NYSE:JNJ) unit. The suit alleged patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Ditropan(R) XL (Oxybutynin Chloride) tablets, 5, 10 and 15 mg....
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sept. 8, 2006--Taro Pharmaceutical Industries Ltd. today reported that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Oxcarbazepine Tablets 150, 300 and 600 mg (oxcarbazepine tablets)....
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In another update to the preliminary injunction issued August 29 in the Plavix case, the cheeky Apotex has filed an appeal with the Court of Appeals for the Federal Circuit against the preliminary injunction preventing the drug company from selling a generic version of the heart drug Plavix. The request came a day after a federal judge had denied Apotex's request to postpone his order last week to halt the company's sales of generic Plavix....
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First to File Status provides Ranbaxy with 180-day Marketing Exclusivity
Gurgaon, India, September 11, 2006 - Ranbaxy Laboratories Limited, announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC)....
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WOODCLIFF LAKE, N.J., Sept. 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the Croatian Financial Services Supervisory Agency (HANFA) has approved for publication its amended tender offer for the purchase of 100% of the shares of PLIVA d.d., based in Zagreb, Croatia. Under the terms of the formal $2.5 billion cash tender offer, PLIVA shareholders who tender their shares will receive HRK 820 per share in cash....
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6-Month Exclusivity on 420mg Diltiazem Strength; First Company with Full Line of Dosage Strengths which are AB rated to Tiazac
ST. LOUIS, September 12, 2006 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it has received approval from the U.S. Food and Drug Administration to market six strengths of Diltiazem HCl ER Capsules (AB rated to Tiazac(R) from Forest Pharmaceuticals, Inc.) through its wholly-owned generic/non-branded subsidiary, ETHEX Corporation. ETHEX will begin shipments of all six strengths immediately....
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PITTSBURGH, Sept. 12, 2006 /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 Topiramate Tablets, 25mg, 100mg and 200mg....
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PRINCETON, N.J., Sept. 13 /PRNewswire/ -- Ranbaxy Laboratories Limited today announced that The District Court of The Hague has handed down a decision in Ranbaxy's case against (Pfizer) Warner-Lambert over the cholesterol-lowering drug, atorvastatin, which is marketed by Pfizer as Lipitor(R)....
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Marietta, Ga. (September 13, 2006) – Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., today announced that it has settled all pending patent litigation with Watson Pharmaceuticals, Inc. and Paddock Laboratories/Par Pharmaceutical Companies, Inc. in connection with each company's Abbreviated New Drug Application (ANDA) for a generic version of AndroGel® (testosterone gel) 1% CIII....
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Alza Corp. appealed a district court's finding of noninfringement and invalidity of claims 1-3, 11, 13 and 14 of U.S. Patent No. 6,124,355 for a generic version of the once-a-day extended release formulation of the anti-incontinence drug oxybutynin, which Alza has been marketing as Ditropan XL®. Alza had sued after Mylan and Impax filed ANDAs for generic once-daily, controlled-release oxybutynin formulations....
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Strong synergy with Genepharm’s existing dermatology products
14 September 2006, Melbourne: Generic medicines pharmaceutical company Genepharm Australasia Limited has entered into a Heads of Agreement with Clinuvel Limited to acquire the EpiPharm range of dermatology products. The five products will be added to Genepharm’s existing range of prescription and OTC dermatologicals to create sales growth with cost synergies....
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BALTIMORE, Sept. 14, 2006 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Ceftriaxone Injection 10 gram vials (Pharmacy bulk pack)....
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Pharmaceutical companies will have greater incentives to develop cheap generic drugs in Australia.
The Intellectual Property Laws Amendment Bill 2006, which amends several pieces of intellectual property (IP) legislation, was passed in Parliament today. “The Bill marks the introduction of new policy initiatives and the improvement of the operation of the legislation” said Bob Baldwin, Parliamentary Secretary to the Minister for Industry, Tourism and Resources....
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SAINTE-FOY, QUEBEC - September 15, 2006 - Bioxel Pharma Inc., a leading manufacturer and supplier of taxane APIs and developer of targeted oncology drugs, is pleased to announce manufacturing of the first industrial scale cGMP batch of its key intermediate for docetaxel....
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In the good old days the situation was simple because it resembled a cowboy film; the good guys (R&D; companies) wore white hats and the bad guys (generic copiers) wore the black hats. Logically speaking, originators should do expensive R&D; to invent new molecules and generic companies should invest nothing in R&D; and just make cheap copies....
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Decision Ends the Litigation Before the Second Circuit
WOODCLIFF LAKE, N.J., Sept. 18 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the United States Court of Appeals for the Second Circuit has denied the plaintiffs' petitions for rehearing and rehearing en banc in the Tamoxifen Citrate antitrust lawsuits. The denial of the petitions follows the Court's November 2005 affirmation of the dismissal of the cases for failure to state a viable antitrust claim. The Court's ruling ends the litigation before the Second Circuit....
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Gurgaon (Haryana), India - September 18, 2006 - Ranbaxy Laboratories Limited announced today that the Company has entered into a strategic in-licensing agreement for the Indian market, with Ethypharm LL India, a wholly-owned subsidiary of a leading French drug delivery company, for a Fixed Dose Combination of Fenofibrate micronized 160 mg and Atorvastatin 10 mg....
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EXETER, N.H., Sept. 19, 2006 -- Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, announced today that it has secured capacity at Cardinal Health’s new North Raleigh facility for the scale-up and manufacture of clinical supplies of Bentley’s intranasal insulin product candidate, facilitating the expansion of clinical trials....
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Mumbai, September 19, 2006: Glenmark Pharmaceuticals, Inc., USA [GPI], the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited [Glenmark], has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets: 4 mg (base), 8 mg (base) and 24 mg (base)....
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-- Combination Doubles Hospira's International Presence and Creates the World's Leading Generic Injectable Pharmaceuticals Company --
-- Transaction Expected to be Accretive to Cash EPS in 2007 --
LAKE FOREST, Ill., Sept. 21, 2006 --...
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ARLINGTON, Va., September 21, 2006 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today released the following statement regarding Wal-Mart's announcement on generic medicines:
As the nation grapples with the problem of increasing healthcare costs, affordable generics have, and will continue to, represent a solution for consumers....
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Apotex's Motion To Stay Rejected; Court Sets Calendar For Appeal
Paris, France and New York, New York (September 21, 2006) -- Sanofi-aventis and Bristol-Myers Squibb announced today that the United States Court of Appeals for the Federal Circuit has denied the motion by Apotex to stay the August 31, 2006 preliminary injunction issued by the United States District Court for the Southern District of New York....
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Gurgaon, India, September 21, 2006 - Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Lasix® Tablets, 20 mg, 40 mg, and 80 mg, respectively, of Aventis Pharmaceuticals Inc. Total annual market sales for Furosemide Tablets were $70 million (IMS – MAT: June 2006)....
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Legislators are stepping up the pressure in the long running saga of getting generic versions of biotech drugs to market. The FDA approves generic versions of pharmaceutical (small molecule) drugs once the patents for brand-name products expire. But complex biotech drugs do not have such an approval process....
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• Free of charge technology transfers to three companies in Africa - South Africa’s Aspen, Cosmos and Universal Corporation in Kenya
• A further 22 companies across 14 countries are interested in Roche AIDS Technology Transfer Initiative...
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Department of Health is Creating Uncertainty in Generics Market
BRUSSELS, 22 September 2006: Speaking at the Annual Conference of the European Generic medicines Association (EGA) in Budapest today, British Generic Manufacturers Association (BGMA) Director Warwick Smith called on the British Government to give generic medicines in the UK a fairer deal....
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FOSTER CITY, Calif.--(BUSINESS WIRE)--Sept. 22, 2006--Gilead Sciences, Inc. today announced that the company has signed eight new non-exclusive license agreements with generic companies in India. These licensing agreements grant to Alkem Laboratories Ltd., Aurobindo Pharma Ltd., FDC Ltd., J.B. Chemicals & Pharmaceuticals Ltd., Matrix Laboratories Ltd., Medchem International, Ranbaxy Laboratories and Shasun Chemicals & Drugs Ltd. the rights to produce and distribute generic versions of tenofovir disoproxil fumarate (tenofovir DF) to 95 low-income countries around the world, including India....
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Via SCOTUSblog, Pfizer recently filed a supplemental brief in opposition to Apotex's petition for certiorari in Apotex v. Pfizer, suggesting that the case is moot. In its cert petition, Apotex asked the Supreme Court decide whether the listing of patent information in the Orange Book creates a justiciable controversy sufficient to form the basis for a declaratory judgment action for noninfringement or invalidity....
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Jerusalem and Carmiel, Israel, September 26, 2006 - Teva Pharmaceutical Industries Ltd. and Protalix Biotherapeutics Ltd. have signed a collaboration and licensing agreement for the development of two proteins, using Protalix's plant cell culture platform. The undisclosed proteins, aimed at large-sized markets are not part of Protalix's current product development pipeline....
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WOODCLIFF LAKE, N.J., Sept. 26 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., today confirmed that it is challenging the patents protecting Savient Pharmaceuticals, Inc.'s Oxandrin(R) (oxandrolone tablets, USP) CIII. The Company indicated it believes it is the first to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for the product....
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HAMILTON, Bermuda, September 26, 2006 - - As disclosed in the Prospectus dated September 20, 2006 filed by Warner Chilcott Limited with the SEC, Warner Chilcott Limited is currently party to litigation with the FTC and 34 states plus the District of Columbia relating to its agreements with Barr for the supply of Ovcon 35. At issue in the litigation are the exclusivity provisions in these agreements, which provide that Barr exclusively supply Ovcon 35 to the Company, and the alleged anti-competitive effects of these provisions. Barr is the Company's sole source of supply for Ovcon 35....
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TOKYO, Sept. 27, 2006-Eisai Co., Ltd. announced today that the lawsuits filed against three generic drug manufacturers, Towa Pharmaceutical Co., Ltd., Taisho Pharmaceutical Industries Ltd. and Sawai Pharmaceutical Co., Ltd., regarding the sales of generic products of “Selbex capsule 50mg” (generic name: teprenone, hereinafter referred to as “Selbex”) based on the Japanese Unfair Competition Prevention Law have been dismissed by the Intellectual Property High Court....
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Orange Book Games: A generic manufacturer asks for a lawsuit when it files an Abbreviated New Drug Application (ANDA) with the FDA along with an assertion that the listed patents either don’t cover the drug or are invalid. That filing gives the brand manufacturer a right to immediately sue for declaratory relief based on a theory of constructive patent infringement....
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WOODCLIFF LAKE, N.J., September 27, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has today launched a generic version of Cephalon Inc.'s ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg cancer pain management treatment product....
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Gurgaon, India, September 27, 2006 - Ranbaxy Laboratories Limited (RLL), today announced that the Company’s wholly owned subsidiary, Ranbaxy Malaysia Sdn Bhd. (RMSB), has launched the first generic Atorvastatin, under the brand name, �Storvas’, in Malaysia. The product introduced on-day-one, will be made available through all major GP’s (General Practitioners), Pharmacies and Hospitals in Malaysia. Storvas will be sold in dosage forms of 10mg, 20mg and 40mg....
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Genepharm and Primary Health to promote benefits of generic substitution
28 September 2006, Melbourne: Genepharm Australasia Limited has entered into an alliance with Primary Health Care Limited to promote Genepharm generics at its medical centres, and educate patients as to the benefits of a generic choice. Primary will also promote the use of Genepharm products as a preferred supplier at the pharmacy outlets at Primary’s large-scale medical centres around Australia....
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BALTIMORE, Sept. 28, 2006 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Lisinopril and Hydrochlorothiazide tablets in 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg strengths....
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Hart-Scott-Rodino Waiting Period Expires Without Comment from Federal Trade Commission
WOODCLIFF LAKE, N.J., September 28, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the Hart-Scott-Rodino (HSR) waiting period for the Company's acquisition of Shire plc's ADDERALL(R) (immediate-release mixed amphetamine salts)...
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WASHINGTON, September 29, 2006 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) expressed its strong support for the Access to Life-Saving Medicine Act, introduced today by U.S. Representative Henry Waxman (D-CA) and Senator Charles Schumer (D-NY), which will bring safe, effective and affordable biopharmaceutical medicines to consumers....
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