Generics Industry News Search
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October 2006 News Archive |
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ALLEGAN, Mich., Oct. 2 /PRNewswire-FirstCall/ -- The Perrigo Company today announced that it has been granted tentative approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Ciclopirox Topical Solution, 8% (Nail Lacquer). Final approval is subject to the expiration of the applicable period of patent protection for the reference listed drug (Penlac® Nail Lacquer, distributed by Dermik Laboratories, a division of Sanofi Aventis Pharmaceuticals USA) as listed in the FDA's Orange Book. The patent will expire on September 18, 2007....
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CHESTER, N.J., October 02, 2006 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. today announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against Mutual Pharmaceuticals Co. and United Research Laboratories, Inc. (URL), both wholly owned subsidiaries of Pharmaceutical Holdings Corp. for infringement of U.S. Patent No. 6,372,252, issued in April 2002....
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03 Oct 2006 - Basingstoke, UK and Philadelphia, US – October 03, 2006 – Shire plc - announces that it has received a Paragraph IV notice letter from Andrx Pharmaceuticals, L.L.C. (Andrx) advising of the filing of an Abbreviated New Drug Application (ANDA) for its amphetamine combination product, a generic version of Shire’s mixed amphetamine salt product, ADDERALL XR®....
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HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 3, 2006--IMPAX Laboratories, Inc. today announced that it and ALZA Corporation and McNeil-PPC have filed with the court a signed stipulation for the dismissal of a patent infringement lawsuit related to the Company's Abbreviated New Drug Application (ANDA) for methylphenidate hydrocholoride ER, 18, 27, 36, 54 mg. tablets, generic of Concerta(R)....
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Auriga Laboratories, Inc., a specialty pharmaceutical company driving high-growth revenues through acquisition of valuable brand portfolios and innovative drug development programs, has executed a term sheet for an agreement authorizing River's Edge Pharmaceuticals, LLC to be the exclusive generic drug distributor of the Company's Extendryl(R) and Levall(R) prescription product lines.
The proposed agreement is designed to provide a number of notable strategic advantages to protect and maximize Auriga's product revenue as it moves into the marketplace for generic versions of its drug brands....
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Gurgaon, India, October 06, 2006 - Ranbaxy Laboratories Limited (RLL), India, today announced that the Company’s wholly owned subsidiary, Ranbaxy Pharmaceuticals Canada Inc. (RPCI) and Janssen-Ortho Inc. (JOI), have entered into a licensing and supply agreement for a generic fentanyl patch, sold under Ranbaxy's label, RAN™ Fentanyl Transdermal System. This is the second product to be commercialized by RPCI as part of a licensing arrangement between the companies....
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ROCKVILLE, Md., Oct. 6, 2006--The Food and Drug Administration, on October 5, 2006, granted tentative approval for didanosine for Oral Solution (Pediatric Powder), 10 mg/mL, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
This is a generic version of the already-approved Videx Pediatric Powder for Oral Solution, 10 mg/mL, manufactured by Bristol Myers Squibb.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR)....
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TEANECK, N.J., Oct. 8 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) and Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu) today announce that they received court decisions on ANDA-related summary judgment motions for Aciphex® (Active Ingredient Name: rabeprazole sodium, Product Name in Japan: Pariet®) on October 6, 2006 (U.S. Eastern time)....
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October 10, 2006, Hyderabad, India: Dr. Reddy’s Laboratories announced today that it has settled patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GlaxoSmithKline’s Imitrex® tablets....
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LARGO, Fla., October 10, 2006 /PRNewswire-FirstCall/ -- GeoPharma, Inc. today announced that Schering-Plough , has filed a lawsuit against the Company and its wholly owned subsidiary, Belcher Pharmaceuticals, Inc. in the United States District Court, District of New Jersey (No. 3:06-cv-04715-MLC-TJB), alleging patent infringement related to Belcher's filing for a generic version of Clarinex(R) Desloratadine 5 mg tablets....
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In Apotex v. Pfizer (Sup. Ct. 05-1006), the Supreme Court said that it will not hear a case brought by generic pharmaceutical company Apotex that was trying to have Pfizer's Zoloft patent invalidated. Zoloft (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) used to treat depression....
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Current and future scientific and regulatory issues for the generic pharmaceutical industry will be the focus of the Generic Pharmaceutical Association's (GPhA) Fall Technical Conference on October 18-19, 2006. This annual conference brings together industry and Food and Drug Administration (FDA) representatives for a unique dialogue on topics such as the FDA Question-based Review initiative, current good manufacturing practices, bioequivalence issues, and the generic drug regulatory environment....
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JERUSALEM--(BUSINESS WIRE)--Oct 12, 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 Janssen's Risperdal(R) (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected upon expiry of patent protection for the brand product on December 29, 2007....
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Jerusalem, Israel, October 16, 2006 - Teva Pharmaceutical Industries Ltd. announced today that patent infringement litigation pertaining to Teva's generic version of Purdue's OxyContin® (oxycodone HCl extended-release) Tablets has been dismissed by the United States District Court for the Southern District of New York pursuant to a settlement between Teva and The Purdue Frederick Company and certain of its affiliates....
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TITUSVILLE, N.J., October 16, 2006 /PRNewswire/ -- Janssen, L.P. today announced that a U.S. District Court upheld the validity and enforceability of the RISPERDAL(R) (risperidone) patent. The injunction that was entered prohibits Mylan Pharmaceuticals, Inc. and Dr. Reddy's Laboratories, Ltd. from selling their proposed generic risperidone products in the U.S. until the Janssen patent on RISPERDAL expires in 2007....
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CHADDS FORD, Pa., Oct. 17, 2006 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc. announced today that its wholly owned subsidiary, Endo Pharmaceuticals Inc., has learned that the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (OGD) has issued, in response to an inquiry, bioequivalence recommendations regarding Endo's patent-protected product, Lidoderm(R) (lidocaine topical patch 5%)....
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NEW YORK, October 17, 2006 /PRNewswire-FirstCall/ -- Pfizer said today that the Austrian Patent Office has ruled that a claim in the company's basic patent covering the use of atorvastatin, the active ingredient in Lipitor, would be infringed by generic manufacturer Ranbaxy. Ranbaxy can appeal the ruling, but the patent will remain in effect during the appeals process. Lipitor is sold in Austria under the brand name Sortis....
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MUMBAI, India, October 182006 - Sun Pharma today announced that it had received tentative approval from the USFDA for Amifostine for injection 500mg, filed from its site in India.
Amifostine is used as an adjuvant in cancer treatment. Sun Pharma’s amifostine injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin....
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PHILADELPHIA, October 18, 2006 /PRNewswire/ -- United Research Laboratories, Inc. and Mutual Pharmaceutical Company, Inc. (Mutual) today announce that the company has filed a counter suit against Adams Respiratory Therapeutics on antitrust, tortious interference and unfair competition grounds. Adams filed lawsuits against Mutual in New Jersey and Pennsylvania alleging patent infringement after the company filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for guaifenesin extended- release tablets, 600 mg and 1200 mg....
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Ruling Addresses the Issue of Judicial Jurisdiction Based on Pediatric Exclusivity
PITTSBURGH, Oct. 19 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today reported that the U.S. District Court for the Western District of Pennsylvania granted Mylan Pharmaceuticals' motion to dismiss the '909 patent from the patent infringement litigation between Pfizer and Mylan concerning Amlodipine Besylate Tablets and thereby removes the '909 as a patent that Pfizer can assert against Mylan. The '909 patent was one of two patents covered in the litigation scheduled to begin on Nov. 28, 2006, in Pittsburgh....
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Court Will Proceed on the Merits of Amgen's Claim That Roche's peg-EPO Infringes Amgen's EPO Patents
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Oct. 20, 2006--Amgen announced that a U.S. Federal District Court in Boston today denied Roche's motion to dismiss Amgen's patent infringement lawsuit against Roche. The court today also denied a motion by Ortho Biotech to intervene as a co-plaintiff in the case....
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ST. LOUIS, October 20, 2006 /PRNewswire-FirstCall/ -- Due to inaccurate external information circulating earlier today, KV Pharmaceutical Company clarified the nature of a Citizen's Petition filed with the U.S. Food & Drug Administration on behalf of the Company. On October 18, 2006, KV's own counsel, Kenyon & Kenyon, filed a Citizen Petition pertaining to generic equivalents of the 100mg and 200mg strengths of Toprol XL(R) (metoprolol succinate extended-release tablets)....
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WOODCLIFF LAKE, N.J., Oct. 20 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today said the U.S. Federal Trade Commission (FTC) has voted 5-0 to permit Barr's acquisition of PLIVA d.d., based in Zagreb, Croatia (LSE: PLVD; ZSE: PLVA-R-A), subject to minimal divestitures of certain overlapping product lines. The FTC vote clears the way for the transaction to close on October 25, 2006....
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HAMILTON, Bermuda, Oct 23, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Warner Chilcott Limited announced today that it has settled the antitrust lawsuit brought by the Federal Trade Commission (FTC) against certain of its subsidiaries involving one of its combined hormonal contraceptives, Ovcon(R) 35. The settlement has been approved by Warner Chilcott's Board of Directors and the Commissioners of the FTC but remains subject to Court approval....
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Pfizer to Seek Correction of Technical Defect in Second Lipitor Patent
NEW YORK, October 23, 2006 /PRNewswire-FirstCall/ -- Pfizer Inc said today the Court of Appeals for the Federal Circuit has denied Ranbaxy's petition for rehearing of an August 2 decision upholding the exclusivity of the main patent covering atorvastatin, the active ingredient in Lipitor. That patent expires in March 2010....
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WOODCLIFF LAKE, N.J., October 23, 2006 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that it's partner, Genpharm Inc. of Toronto, Canada, has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for pravastatin 10 mg, 20 mg, and 40 mg tablets. Pravastatin is the generic version of Bristol-Myers Squibb's Pravachol(R) and is used for treatment of certain hyperlipidemias. Par will begin shipping the product immediately....
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Japan, October 23, 2006 - Astellas Pharma Inc. today announced that Astellas, Toyo Pharmar Co., Ltd., and ASKA Pharmaceutical Co., Ltd. have reached a settlement in the patent infringement lawsuit, which Astellas filed on November 29, 2005 with the Tokyo District Court demanding that Toyo Pharmar and ASKA Pharmaceutical stop infringing Astellas' patent rights on its modified release formulation of tamsulosin hydrochloride (brand name: Harnal 0.1mg/0.2mg Capsules).
The modified release formulation patent on tamsulosin hydrochloride has terminated on March 6, 2006....
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KVISTGÅRD, Denmark, Oct. 24, 2006--In Bavarian Nordic’s patent infringement action against Acambis plc’s MVA-based smallpox vaccine products at the U.S. International Trade Commission (ITC), the Commission has announced a new target date for the Final Determination. The decision is now expected no later than 8 January 2007.
The Commission has also announced a new date for determining whether to review the Initial Determination. This decision is now expected on 22 November 2006....
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TITUSVILLE, N.J., October 24, 2006 /PRNewswire/ -- A U.S. District Court has granted the request of Ortho-McNeil Neurologics, Inc., a subsidiary of Johnson & Johnson, for a preliminary injunction against Mylan Laboratories, Inc. prohibiting Mylan from launching a generic version of topiramate (TOPAMAX(R)) prior to a final court decision on the validity of the patent....
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HAYWARD, Calif.--(BUSINESS WIRE)--Oct 26, 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) Tablets (Colestipol Hydrochloride Tablets) 1 gram....
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Madrid, Spain Court of Appeal Confirms Pfizer's Patent Claims
NEW YORK, October 27, 2006 /PRNewswire-FirstCall/ -- Pfizer Inc said today that the European Patent Office (EPO) has issued an opinion upholding, in its entirety, the company's calcium salt patent covering Lipitor....
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Companies Must Sell Overlapping Drug Lines to Gain FTC Approval
WASHINGTON, Oct. 31, 2006-The Federal Trade Commission today announced its decision to challenge the terms of Waston Pharmaceuticals, Inc.’s proposed $1.9 billion acquisition of Andrx Corporation, a deal that would have led to competitive problems in the markets for 13 generic drug products. In allowing the deal to proceed while addressing these competitive problems, the Commission has ensured the maintenance of competition that otherwise would have been lost through the acquisition, and protected consumers from likely higher prices for the drugs....
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Bristol-Myers Squibb have conveniently placed updates to the Plavix litigation case on the website below....
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Eisai Co., Ltd. and Eisai Inc. today announced that they received court decisions on ANDA-related summary judgement motions for Aciphex® (Active Ingredient Name: rabeprazole sodium, Product Name in Japan: Pariet®) on October 6, 2006 (U.S. Eastern time). Eisai won summary judgement for patent validity in its lawsuit against Teva and Dr. Reddy's over generic Aciphex (rabeprazole)....
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