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news.Mylan has announced that its subsidiary Alphapharm has won a favorable decision in patent litigation against it and Barr Laboratories relating to galantamine tablets, USP, the generic version of Ortho-McNeil's Razadyne tablets, 4mg, 8mg and 12mg.
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On August 27, the US District Court of Delaware invalidated the sole ‘orange book’ patent asserted against Alphapharm by Janssen Pharmaceutica, Janssen LP and Synaptech. Alphapharm was first to file an abbreviated new drug application (ANDA), along with other generics companies, for galantamine tablets.
The FDA has also 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.
Robert Coury, vice chairman and CEO of Mylan, said: “We are very pleased with the court’s ruling on this first-to-file patent challenge, which once again continues to underscore our ability to effectively pursue and monetize paragraph IV opportunities.”