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Mylan Inc. (NYSE: MYL) announced that its subsidiary Alphapharm Pty Limited won a favorable decision in patent litigation against it and Barr Laboratories Inc. (NYSE: BRL) relating to Galantamine Tablets, USP, the generic version of Ortho-McNeil's Razadyne(R) Tablets, 4 mg, 8 mg and 12 mg.
On August 27, the U.S. District Court for the District of Delaware invalidated the sole "Orange Book" patent (U.S. Patent No. 4,663,318) asserted against Alphapharm by Janssen Pharmaceutica NV, Janssen LP and Synaptech Inc. Alphapharm was first to file an Abbreviated New Drug Application (ANDA), along with other generics companies, for Galantamine Tablets.
The U.S. Food and Drug Administration (FDA) yesterday approved Alphapharm's ANDA. Mylan Pharmaceuticals, another Mylan subsidiary, intends to immediately launch the product on behalf of Alphapharm. Alphapharm and other applicable ANDA holders will be awarded 180 days of shared marketing exclusivity.[SM]
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