Endo receives para IV certification notice from Watson for lidocaine topical patch

Endo Pharmaceuticals and its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. have received a Paragraph IV Certification Notice from Watson Laboratories. Watson has filed an ANDA for a generic version of LIDODERM® (lidocaine topical patch 5%). The certification refers to U.S. Patent No. 5,827,529, which covers the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999 wherein the patent shall expire in 2015. The company is currently reviewing the details of this notice from Watson. Endo intends to vigorously defend LIDODERM's intellectual property rights and pursue all available legal and regulatory pathways in defense of LIDODERM. 

Perrigo can commrecially launch desloratadine after settlement of patent litigation

All Hatch-Waxman litigations relating to Perrigo's Desloratadine tablets (5 mg) has been settled with Perrigo taking a license under all relevant patents. Perrigo had been sued for patent infringement of US Patent Nos. 6100274, 7214683 and 7214684 based upon its filing of an ANDA containing a Paragraph IV certification. As per the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or OTC product depending on its status at the time of launch. The Perrigo product is awaiting FDA approval. Perrigo's generic seeks an AB-rating as equivalent to Schering-Plough's Clarinex(R) tablets (5 mg) indicated for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. Sales for the brand were approximately $300 million, according to Wolters Kluwer data for the twelve months ending October 2008.