Tuesday, November 2, 2010

Lupin Gets FDA Nod For Desloratadine 5 mg -- A Generic Clarinex® -- But It Matters Not

About a year and a half ago, legacy Schering-Plough entered pay-to-delay deals with about 15 generic manufacturers, to keep generic Clarinex® (desloratadine) 5 mg out of the US markets until at least July 2012. See this this vintage AP report:

. . . .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. . . .

Just this morning, news outlets in India -- Lupin's home country -- began reporting the FDA clearance -- and Lupin's stock rose on the news:
. . . .Lupin announced today that its US subsidiary, Lupin Pharmaceuticals, has been granted final appoval for Desloratadine Tablets 5 mg by US Food and Drug Administration. . . .

However, it still appears (based on my review -- see note (f) to that $20.7 billion patent cliff table) that the earliest Lupin may start selling in the US is July 2012 -- and when it does, Orchid Pharmaceuticals will be there, having previously received FDA clearance (in March of 2010), and likely along with several others as well -- by then.

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