Warner files lawsuit for Infringement of Doryx (US 6,958,161) Patent

Warner and one of its subsidiaries and "Mayne", a subsidiary of Hospira Inc. have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

Warner markets and sells DORYX DR tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008. The lawsuit is in response to the submission of an ANDA) to the USFDA by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg DR tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

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Lupin receives USFDA approval for Levetiracetam tablets

Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Company's ANDA for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the USFDA. Commercial shipments of the product have commenced. Lupin's Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals' Keppra(R) tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy.

Cypress receives FDA approval of Levetiracetam oral solution

Cypress has been granted final approval by USFDA for it's ANDA for Levetiracetam Oral Solution, 100 mg/mL. Levetiracetam Oral Solution, 100 mg/mL is the AB-rated bioequivalent generic to UCB Pharma's Keppra® Oral Solution, 100 mg/mL.