Schering-Plough Corporation (NYSE: SGP) today announced an agreement with Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc. ("Orchid"), related to the generic manufacturing of certain formulations of CLARINEX(R) (desloratadine).
The agreement marks the end of all pending litigations filed and consolidated since 2006 in the U.S. District Court for the District of New Jersey against several generic drug manufacturing companies that had sought approval to market solid oral dosage forms of desloratadine products in the United States as generic brands prior to the expiration of certain Schering Corporation patents.
This agreement resolves all pending patent infringement litigation filed by Schering Corp. against Orchid and will allow Orchid to introduce a generic version of the CLARINEX(R) brand REDITABS (orally-disintegrating tablets) to be introduced into the U.S. market on January 1, 2012, and CLARINEX(R) brand 5 milligram tablets to be introduced on July 1, 2012. Schering holds various patents related to CLARINEX(R) that extend to 2022.
Beginning in September of 2006, Schering Corp. filed complaints for patent infringement against generic drug manufacturing companies that sought U.S. marketing rights for generic versions of CLARINEX tablets, CLARINEX REDITABS and/or CLARINEX-D12/-D 24 Extended Release Tablets. Since then, consent orders have been entered and/or settlements now have been reached in the cases against Anchen Pharmaceuticals, Inc., Belcher Pharmaceuticals, Inc., Caraco Pharmaceutical Laboratories, Ltd., Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd., GeoPharma, Inc., Glenmark Pharmaceuticals Inc., USA, Glenmark Pharmaceuticals, Ltd., Lupin Pharmaceuticals, Inc. and Lupin Ltd., Mylan Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals Ltd. and Orgenus Pharma, Inc., Perrigo Co., L. Perrigo, Co., Ranbaxy Inc., Ranbaxy Laboratories Limited, Sandoz Inc., Sun Pharmaceutical Industries Ltd., Watson Laboratories, Inc. and Watson Pharmaceuticals, Inc. and Zydus Pharmaceuticals, USA, Inc., thereby resolving the actions between Schering Corp. and these parties.
The terms agreed to with Orchid on timing of market introduction in the U.S. will apply retroactively as appropriate to the previously negotiated agreements. Also, the Orchid agreement provides for potential modification of its terms. The law suit is still pending until an order of dismissal is signed by the court. Under current law, the agreement can be reviewed by the U.S. Federal Trade Commission and U.S. Department of Justice.
CLARINEX brand 5 mg tablets and REDITABS, a nonsedating antihistamine, offers relief from seasonal allergic rhinitis and perennial allergic rhinitis, as well as chronic idiopathic urticaria, or hives of unknown cause. CLARINEX-D 24 Extended Release Tablets is the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms. Total U.S. sales for CLARINEX products were $295 million in 2008.
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