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Migraine Med Causes Patent Litigation Headaches

By Robyn Hagan Cain on September 09, 2011 | Last updated on March 21, 2019

Dr. Reddy’s Laboratories, the generic pharmaceutical giant, filed an appeal with the Federal Circuit Court of Appeals this week to challenge a U.S. District Court decision barring the company from producing a drug before 2025. Alphapharm and Par Pharmaceutical are joining Dr. Reddy’s in the appeal.

The medication in question is Treximet, a migraine treatment developed by Pozen, Inc. and marketed in the U.S. by GlaxoSmithKline. Treximet generated $15.4 million in 2010 U.S. royalty revenue for Pozen, according to WRALTechwire. A Posen-produced drug similar to Treximet is also marketed in South America by Cilag, a subsidiary of Johnson and Johnson.

Pozen holds three patents on Treximet; two which expire in 2017, and one that expires in 2025. Under the ruling in the case, generic manufacturers could not receive Food and Drug Administration (FDA) approval for their own versions of Treximet until February 2025.

The FDA approved Treximet in 2008, three years after Pozen filed a new drug application for the medication. Par Pharmaceuticals, a party to the district court suit, filed an application for approval of its generic version of the drug later that year, reports the AP.

It's been a busy year for the legal department at the Hyderabad-based Dr. Reddy's; in August, the company announced that it had reached a settlement with Pfizer in the Lipitor litigation. Details of the settlement were not released. In March, AstraZeneca sued Dr. Reddy's for patent infringement related to ZIMOVO delayed-release tablets.

Dr. Reddy's is India's second-largest generics pharmaceutical company.

For more patent litigation news, be sure to check out FindLaw's Federal Circuit blog.

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