Mylan settles with Novartis on Femara
Folic acid is safe - but it lacks any cardiovascular benefits - according to researchers presenting at the American Heart Association’s Scientific Sessions 2008. The results from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), a 12,064-person, randomized study, were presented as a late-breaking clinical trial. Researchers reported that
Full Post: Folic acid does not offer any cardiovascular benefits
Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara.
Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this agreement, which demonstrates our ability to once again bring to market high quality, affordable medications for the patients who need them the most.”
Under the agreement, Mylan is provided a patent license that will enable the company to market Letrozole Tablets, 2.5 mg, prior to the expiration of U.S. Patent No. 4,978,672. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Letrozole Tablets, which are used in the treatment of breast cancer, had U.S. sales of approximately $470 million for the 12 months ending Sept. 30.
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has entered into separate settlement agreements related to ongoing patent challenges for Nasacort AQ (triamcinolone acetonide) nasal spray, Allegra D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra (fexofenadine) 30mg, 60mg and 180mg tablets. As part of the settlements, the
Full Post: Barr announces agreements on Nasacort AQ, Allegra D-12 and Allegra patent challenges
AstraZeneca has announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA. The agreement settles the patent infringement litigation filed by AstraZeneca following Teva’s submission to the United States Food & Drug Administration of an Abbreviated New Drug
Full Post: AstraZeneca settles U.S. Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals
Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis’ Lescol(R) Capsules. Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application
Full Post: Mylan confirms generic Lescol patent challenge
Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules. Mylan
Full Post: Mylan confirms first-to-file patent challenge of AMRIX capsules
PDL BioPharma, Inc. and Alexion Pharmaceuticals, Inc. today jointly announced that the companies have entered into a definitive license agreement and settlement agreement that resolve the legal disputes between them relating to Alexion’s humanized antibody, Soliris (eculizumab) and PDL’s patents known as the Queen et al. patents. Under the agreements announced today, PDL has granted
Full Post: PDL BioPharma and Alexion Pharmaceuticals resolve patent dispute