San Diego’s Somaxon Pharmaceuticals, which overcame setbacks before winning FDA approval for its insomnia drug last year, is now facing some stiff new challenges, according to an interesting story by Keith Darcé of The San Diego Union-Tribune.
As we explained last year, Somaxon already was facing stiff competition from over-the-counter sleeping aids and other generics after the FDA finally approved its application for doxepin, its sleeping pill marketed as Silenor. Now four generic drug-makers are challenging Somaxon’s patents as part of their requests for FDA approval to sell lower-cost generic versions of doxepin.
Somaxon, which declined to comment in the U-T, has filed lawsuits against the generic drugmakers, Par Pharmaceutical of Woodcliff Lake, N.J.; Zydus Pharmaceuticals of Pennington, N.J.; Mylan of Canonsburg, Pa.; and Actavis of Morristown, N.J. The four generic drug companies also declined to comment.
The lawsuits provide a nearly three-year delay in efforts to get the generic drugs to market, but litigation is costly. Stay tuned as this one gets sorted out.
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