Somaxon Fighting Fresh Challenge from Generic Drug-Makers

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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.