Generics Industry News Search
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February 2006 News Archive |
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., and Cephalon, Inc. have entered into agreements to settle its pending patent infringement disputes in the United States related to Cephalon's ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and PROVIGIL(R) (modafinil) Tablets [C-IV] products....
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Endo Pharmaceuticals Holdings Inc. today announced that the Federal Circuit Court of Appeals has vacated its unanimous June 7, 2005 affirmance of the Opinion and Order issued in Endo's favor by the U.S. District Court for the Southern District of New York, which found Purdue liable for its inequitable conduct in the U.S. Patent and Trademark Office....
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The Hyderabad based NATCO Pharma Limited has announced the acquisition of a Pharmacy outlet, NICK's Drug Store based out of Newark, New Jersy, United States. The acquisition has been made by an American partnership firm, in which NATCO holds 75% majority stake....
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Israeli generics company Unipharm has successfully challenged patents protecting esomeprazole and eprosartan in its domestic market....
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Dr. Reddy's Laboratories Ltd. announced that it would market authorised copies of U.S.-based Merck & Co.'s cholesterol drug Zocor and prostate medicine Proscar, once the patents on the two drugs expire....
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The Perrigo Company announced today that it has received approval from the US Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polacrilex lozenges, 2mg and 4mg....
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Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, and Community Investment Holdings (CIH), South Africa, has entered into an agreement to form a Joint Venture (JV) christened “Sonke Pharmaceuticals (Pty) Ltd”, to market and sell Ranbaxy’s range of Anti-Retroviral (ARV) products in South Africa and other African markets....
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Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg....
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After stirring up global markets in 2001 by offering its generic anti-AIDS drug for less than $1 a day when the market price was $15,000 a year, Cipla is now ready with AntiFlu, the generic version of Tamiflu — Swiss pharma major Roche’s most sought anti-influenza drug for bird flu....
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ARLINGTON, Va., Feb. 8 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today issued the following statement in response to Pfizer's February 8 press release. GPhA has not reviewed the citizen petition referred to in Pfizer's release and, as a general matter, does not comment on patent litigation matters....
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Pfizer Inc said today that it has filed a Citizen Petition alerting the FDA that generic azithromycin products sold by Teva Pharmaceuticals U.S.A. and Sandoz Inc. appear to be misbranded because their labels do not accurately describe the drugs' active ingredients....
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The Federal Court of Australia New South Wales District Registry has heard the first direction hearing between Alphapharm and Merck regarding the dispute over patent number AU625704....
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The US FDA has announced that Mikart Inc. has received final approval for its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5mg/300mg....
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Jerusalem, Israel, February 9, 2006 - Teva Pharmaceutical Industries Ltd. today commented on Pfizer's February 8th press release regarding azithromycin. Although Teva has not yet seen the Citizen Petition or the complaint relating to the infringement actions referenced in the press release, Teva believes that these allegations are baseless and without merit....
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Aurobindo Pharma Ltd is pleased to announce that, through its wholly owned subsidiary Aurex Generics Limited, UK has entered into Share Purchase Agreement with Whyte Group Limited and Iracot Limited to acquire UK based Milpharm Limited, the generic formulation pharmaceutical company engaged in selling generic formulations, mainly in the UK market....
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SCHAUMBURG, Ill., Feb. 13 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners (APP), Inc., today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Octreotide Acetate Injection, single-dose and multiple dose vials, the generic equivalent of Novartis Pharmaceuticals's Sandostatin(R) Injection....
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Jerusalem, Israel, February 13, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Adenosine Injection, 3 mg/mL in 20 mL and 30 mL single dose vials....
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St. Louis, MO, February 14, 2006 – KV Pharmaceutical Company and Gedeon Richter, Ltd. announced today that KV Pharmaceutical Company has acquired exclusive rights from Gedeon Richter, Ltd. to market a broad group of generic drug products in the U.S. marketplace through KV’s wholly-owned generic marketing division, ETHEX Corporation....
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Abrika Pharmaceuticals has announced it has begun shipment of Isradipine Capsules in 2.5mg and 5mg dosage forms....
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PRINCETON, NEW JERSEY (February 15, 2006) -- Bristol-Myers Squibb today announced an agreement for technology transfer and voluntary license with generic manufacturers Aspen PharmaCare and Emcure Pharmaceuticals for atazanavir, the company's once-daily protease inhibitor for HIV/AIDS that was initially approved in the U.S. in June 2003 for use in combination therapy with other anti-HIV medicines....
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WOODCLIFF LAKE, N.J., Feb. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the United States Court of Appeals for the Federal Circuit has affirmed a February 2005 lower court decision that granted summary judgment in favor of its wholly owned subsidiary, Barr Laboratories, Inc., in the Company's challenge to the patent for DDAVP(R) (Desmopressin Acetate) Tablets, 0.1 mg and 0.2 mg....
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PLIVA d.d. announced today that an agreement has been signed with Novartis’ generics division, Sandoz, for the purchase of its Spanish subsidiary Uso Racional S.L (UR) for a total cash consideration of EUR 21.5m. With expected sales of about EUR 12m in 2006, UR represents a well known and established generics brand in Spain, with a small dedicated sales force and a complementary product portfolio and attractive pipeline....
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SCHAUMBURG, Ill., Feb 16, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- American Pharmaceutical Partners, Inc., today announced that it has received two approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Ceftriaxone for Injection, USP, with FDA's clearance of the issues surrounding the raw material supplier for this product....
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In Ferring B.V., and Aventis v. Barr Labs, (05-1284), the Court of Appeals for the Federal Circuit, deemed a patent unenforceable due to inequitable conduct where the inventors submitted declarations to the examiner in order to define the term “peroral” but did not disclose to the examiner that some of the declarants had been employed by the applicant’s company or performing paid research for the company....
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Hyderabad, India, Frankfurt & Augsburg, Germany, February 16, 2006: Dr. Reddy’s and 3i, Europe’s leading private equity house, jointly announced today that they have entered into a definitive agreement providing for the strategic investment by Dr. Reddy’s to acquire 100% of betapharm Group, the fourth-largest generic pharmaceuticals company in Germany, for a total enterprise value of € 480 million in cash....
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Jerusalem, Israel, February 16, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Rabeprazole Sodium Delayed-Release Tablets, 20 mg....
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SCHAUMBURG, Ill., Feb. 17 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc., today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carboplatin Injection (liquid form) in a 600 mg multi-dose vial....
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NEW YORK, February 21 -- Pfizer Inc said today that the Helsinki Court of Appeal in Finland has granted a preliminary injunction against Ranbaxy Laboratories Ltd. that prohibits the manufacturer from marketing a generic version of Lipitor....
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Allegan, Mich. - Feb. 22, 2006 - The Perrigo Company today announced that, through a partnership with InvaGen Pharmaceuticals, it has received tentative approval from the U.S. Food and Drug Administration (FDA) to market Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg....
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COLUMBUS, OH - February 22, 2006- Roxane Laboratories, Inc. today announced the approval of Fluticasone Propionate Nasal Spray, 50mcg....
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Osaka, Japan and Lincolnshire, III. - Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. announced today that Takeda's intellectual property rights have been successfully asserted against generic manufacturers seeking to challenge Takeda's patent rights to ACTOS (pioglitazone HCl)....
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On January 17, 2006 Judge Rodney Sippel of the U.S. District Court for the eastern district of Missouri has ruled under summary judgment in favor of the generic challengers, clearing their way to launch generic versions of Toprol-XL in U.S. market. This is, however, a pyrrhic victory for generic manufactures after successive para IV defeats in Lipitor (Atorvastatin Calcium, Ranbaxy losing to Pfizer), Accupril (Quinapril Hydrochloride, Ranbaxy losing to Pfizer), Norvasc (Amlodipine Besylate, Dr. Reddy’s loses to Pfizer) and Zyprexa (Olanzapine, Dr. Reddy’s loses Eli Lilly)....
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Spring Valley, New York, Feb. 23, 2006 — Par Pharmaceutical Companies, Inc. today announced that it has entered into a supply and distribution agreement with GlaxoSmithKline (GSK) in the United States to distribute fluticasone propionate aqueous nasal spray, 50mcg, which is fully substitutable for GSK's Flonase®....
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Eli Lilly and Co. has sued Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug company, seeking to block it from selling a generic version of the cancer drug Gemzar. The lawsuit comes one month after Teva and its subsidiary Sicor Pharmaceuticals Inc. petitioned the Food and Drug Administration for permission to manufacture a generic form of Lilly's No. 2-selling medication....
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IRVINE, Calif., Feb. 23 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that it has entered into a strategic alliance with Par Pharmaceutical Companies, Inc. for the sale and distribution of Spectrum's generic drugs. As of the date of signing the agreement, Spectrum had three Abbreviated New Drug Applications (ANDAs) approved, and nine under review by the United States Food and Drug Administration (FDA)....
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PITTSBURGH, Feb. 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg....
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Spring Valley, New York, Feb. 24, 2006 — Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of Maryland last night granted GlaxoSmithKline (GSK) its motion for a temporary restraining order (TRO) to set aside the U.S. Food and Drug Administration's (FDA) final decision approving an abbreviated new drug application (ANDA) for a generic version of Flonase (fluticasone propionate) Nasal Spray. While the TRO is pending, the approval and any future approval by the FDA of an ANDA allowing the marketing and sale of a generic version of GSK's Flonase Nasal Spray is and shall be suspended....
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DETROIT, Feb 24, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- 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 Fluvoxamine Maleate 25mg, 50mg and 100mg strength tablets....
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Jerusalem, Israel, February 26, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company?s ANDAs for Ondansetron Injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials and Ondansetron Injection USP, 2 mg/mL, packaged in 40 mg/20 mL multiple-dose vials....
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On 24 February 2006, the US CAFC handed down its decision in SmithKline v Apotex....
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EXETER, NH, February 27, 2006 – Bentley Pharmaceuticals, Inc., a specialty pharmaceutical and drug delivery company, today announced that it has received twelve marketing approvals in Spain for various dosage forms of citalopram (generic version of Celexa®), finasteride (generic version of Proscar®) and pravastatin (generic version of Pravachol®)....
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The U.S. Court of Appeals for the Federal Circuit, in SmithKline Beecham Corp. and GlaxoSmithKline v. Apotex Corp (04-1522), held that once a product is fully disclosed in the art, future claims to that same product are precluded, even if that product is claimed as made by a new process....
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MUNICH, Germany, February 27 /PRNewswire/ -- Astellas Pharma GmbH, the German subsidiary of Astellas Pharma Inc., Tokyo, is distributing the product Omnic Ocas(R) 0.4 mg tablets (active substance: tamsulosin hydrochloride) in Germany for the treatment for the functional symptoms of benign prostate hyperplasia. Astellas Pharma Inc. is the owner of an European patent relating to tamsulosin hydrochloride modified release capsule formulation....
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BRISTOL, Tenn., Feb. 27 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. today reported that King, Aventis Pharma Deutschland GmbH (now known as Sanofi-Aventis Deutschland GmbH) and Cobalt Pharmaceuticals, Inc. have entered into an agreement to dismiss the pending litigation relating to the enforcement of U.S. Patent Nos. 5,061,722 (the '722 Patent) and 5,403,856 (the '856 Patent)....
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