Barr Labs confirms patent challenge of Amrix extended-release capsules
Surgery to treat obesity could be avoided if GPs and healthcare trusts put more time and money into early stage weight management programmes, a senior clinical researcher will say today (Wednesday, 17 December, 2008). And he will say that patients suffering from obesity face a “post code lottery” when seeking access to specialist care. Speaking
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Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Amrix with the U.S. Food & Drug Administration (FDA), and following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) holder and patent owner.
On November 26, 2008, Eurand, Inc., Cephalon, Inc., and Anesta AG filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg had annual sales of approximately $53 million in the U.S., based on IMS sales data ending September 2008.
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
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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
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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
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Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength. Bupropion Hydrochloride Extended-Release Tablets is the generic equivalent to GlaxoSmithKline’s Wellbutrin XL(R) product,
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Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s
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