Generics Industry News Search
 |
|
|
|
|
|
|
October 2009 News Archive |
|
|
| |
|
Impax Laboratories, Inc. today announced that it is commencing shipment of its authorized generic version of Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg, through Global Pharmaceuticals, Impax's generic division. Shire Pharmaceuticals markets Adderall XR for the treatment of Attention Deficit Hyperactivity Disorder ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
US campaigners yesterday urged Congress to create a "real" regulatory pathway for generic versions of biologic drugs, but researchers warn that it may take until 2011 to implement any such policies...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Actavis today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Caraco Pharmaceutical Laboratories, Ltd. announced that, as part of the previously announced settlement of the legal proceedings related to Lexapro (escitalopram oxalate) tablets, it closed an Asset Purchase Agreement transaction with Forest Laboratories, Inc. (Forest) to acquire several products from Forest's Inwood line of business. The ANDA patent litigation settlement resolves litigation involving Caraco, Forest, Forest Holdings, Ltd., and H. Lundbeck A/S and Sun Pharmaceutical Industries Limited...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Impax Laboratories, Inc. today confirmed that the U.S. Food and Drug Administration has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Flomax (tamsulosin hydrochloride) 0.4mg capsules...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sandoz today announced the launch of its recombinant human growth hormone somatropin in Japan, the first-ever biosimilar to be approved and launched on the world's second largest pharmaceutical market. The launch follows the precedent-setting approval of somatropin - already marketed as Omnitrope in the EU, the US, Australia and elsewhere - by Japan's Ministry of Health, Labor and Welfare in June of this year...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
French drugmaker Sanofi-Aventis is preparing to sell its own generic version of the blockbuster heart medicine Plavix in France, a company spokesman said on Monday...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Ranbaxy Laboratories Limited and Daiichi Sankyo Company Limited announced today that the portfolio of Daiichi Sankyo would be commercialized in Mexico through a recently created marketing Division within Ranbaxy Mexico S.A. de C.V., a subsidiary of Ranbaxy. This is the first time in Latin America that Daiichi Sankyo and Ranbaxy are leveraging mutual synergies generated through the Hybrid Business Model...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Drug makers Sanofi-Aventis SA, Novartis AG and Ratiopharm International GmbH said Wednesday that EU regulators had carried out surprise raids at their French offices as part of an antitrust probe...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Impax Laboratories, Inc. today announced that it has reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for Flomax (tamsulosin hydrochloride) capsules through the entry of a consent judgment confirming the validity and infringement of the patent....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The U.S. District Court for the District of New Jersey has signed off on Sanofi-Aventis' settlement agreement with Sun Phatmaceutical Industries Ltd. despite the fact that Sanofi failed to exchange all relevant signature pages. The agreement ends the litigation over a generic version of Eloxatin, a colon cancer drug manufactured and marketed by Sanofi...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India's largest pharma company Ranbaxy on Wednesday said its French unit has been raided by European antitrust officials as part of a probe on cozy drugs settlements which allegedly delay the launch of low-cost generic drugs...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Medicines Company today announced that it has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and APP Pharmaceuticals, LLC, and related entities in the United States District Court for the District of Delaware alleging patent infringement based on Abbreviated New Drug Applications seeking U.S. Food and Drug Administration approval to market and sell generic versions of The Medicines Company's Angiomax product prior to expiration of U.S. Patent No. 7,582,727...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Hospira, Inc., the world leader in generic injectable pharmaceuticals, today signed a Business Cooperation Agreement with South Korea-based Celltrion, Inc. and Celltrion Healthcare, Inc. (Celltrion), which outlines the business terms of a future distribution agreement for the United States, Europe, Australia, New Zealand and Canada for eight biogeneric products that are currently under development by Celltrion, five of which are incremental to Hospira's pipeline...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The agency approved Anmeal Pharmaceuticals' cetirizine hydrochloride syrup in the 5 mg-per-5 milliliter strength.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,455,574 (Therapeutic Combination, issued September 24, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Pfizer's Caduet (atorvastatin calcium and amlodipine besylate) ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Shire plc, the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. (Sandoz) in connection with Sandoz's Abbreviated New Drug Application and its attempt to market generic versions of Shire's Adderall XR (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Perrigo Company today announced that it has filed an Abbreviated New Drug Application for over-the-counter Minoxidil topical aerosol foam, 5%, a generic form of Men's Rogaine Foam. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. today announced that the company's Mylan Pharmaceuticals and Matrix Laboratories subsidiaries entered into a settlement and license agreement with Pfizer Inc. relating to Voriconazole Tablets, 50 mg and 200 mg, the generic version of Pfizer's Vfend Tablets, a triazole antifungal agent...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Pfizer Inc today announced that it has entered into an agreement with two subsidiaries of Mylan Inc. relating to a generic version of Vfend (voriconazole), an antifungal agent. The agreement is limited to the tablet form of Vfend and does not cover Pfizer's Vfend products for intravenous use or oral suspension...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
In answer to a complaint filed in the U.S. District Court for the Southern District of New York by Gilead Sciences Inc. over alleged patent infringement, Teva Pharmaceuticals has filed an amended answer and counterclaim alleging that the patents-in-suit are invalid...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Teva Pharmaceutical Industries Ltd. commented today on the abbreviated new drug application containing a Paragraph IV certification for Copaxone (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva also announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Daiichi Sankyo-owned Ranbaxy Laboratories has won a decisive ruling from the District Court of New Jersey that its generic version of valganciclovir, prescribed for HIV/Aids patients and for organ transplantation-related infections, does not infringe the patent rights of Swiss drug maker Roche's anti-infection drug, Valcyte...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The principal debate involving follow-on biologics legislation has revolved around the length of the data exclusivity term granted to innovators. The bill voted out of the Senate Health, Education, Labor and Pensions (HELP) Committee earlier this year has a 12-year data exclusivity term, which is shorter than the term supported by industry groups such as the Biotechnology Industry Organization (BIO) and also shorter than the term supported by the only peer-reviewed economic analysis of record...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Perrigo Company announced today that the Hatch-Waxman litigation relating to Duac Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice. Earlier this year, KV Pharmaceuticals had been sued by Stiefel for infringement of a patent related to KV's filing of an Abbreviated New Drug Application (ANDA) for a generic to Duac Gel in the United States District Court for the District of Delaware...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Cephalon, Inc. today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL (armodafinil) Tablets [C-IV]. In the Notice Letter, Teva alleges that U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") issued to Cephalon are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in Teva's ANDA submission....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Genericlicensing Limited (a joint venture between Pharmalicensing.com and ICE Pharma Group) had a double celebration this week. Reaching a milestone 1,000 products available online and the launch of the world's first printed Global Generic Product Directory (directory.genericlicensing.com). ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Novartis AG expects the decline in U.S. sales of its best-selling drug Diovan to accelerate from April next year, when generic Cozaar will be launched, Joe Jimenez, the head of the pharmaceutical unit, said Thursday. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
India and Brazil will take the European Union to court at the World Trade Organisation, diplomats said on Thursday, raising the stakes in a bitter dispute over seizures of generic drugs...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
The Federal Trade Commission and several national pharmacy chains are suing Marietta-based Solvay Pharmaceuticals Inc. for allegedly colluding to block the generic release of AndroGel, a top-selling product...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Allergan, Inc. announced today that the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd. (Exela), Apotex, Inc. and Apotex Corp. (Apotex) (collectively, the Defendants) for seeking to market purported generic versions of Allergan's drugs Alphagan P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Seeking to protect its patent for its popular anti-cholesterol drug Lipitor, pharmaceutical giant Pfizer Inc. has filed a patent infringement case against local competitor United Laboratories Inc....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Sun Pharmaceuticals has agreed not to manufacture and market the generic version of Alzheimer's drug of Forest Laboratories, after it lost patent battle with the US drugmaker on Thursday. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Shire plc, the global specialty biopharmaceutical company, announces that the Food and Drug Administration, following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the completion of decentralised procedure (DCP) for generic docetaxel, and expects to launch across most of Europe between now and the end of 2010...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Bayer AG lost a bid to have a court overturn a ruling that said its U.S. patent on the birth-control pill Yasmin is invalid...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
A unit of Sanofi-Aventis SA, France's biggest drugmaker, accused U.S. rival Hospira Inc. and Canada's Apotex Inc. of infringing patents for the cancer drug Taxotere as a non-jury trial began today...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that its subsidiary Watson Laboratories, Inc. has reached a settlement with Barr Laboratories, Inc. on outstanding patent litigation related to Watson's Oxytrol (Oxybutynin Transdermal System, 3.9mg/24hr.) product...
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your
company press releases at GenericsWeb, please
email us.
|
Home
