Drug developer Pozen Inc. said Monday that a Texas court upheld three patents supporting its migraine drug Treximet.
Pozen said the U.S. District Court for the Eastern District of Texas ruled that the patents were valid. The court also found that generic versions of Treximet developed by Par Pharmaceutical Co. and Dr. Reddy's Laboratories Ltd. infringed on all three patents, while a version developed by Alphapharm Pty Ltd. infringed on two patents. Teva Pharmaceutical Industries Ltd. had also challenged the patents, but was dismissed from Pozen's lawsuit in April 2010 after it agreed to abide by the court's decision.
The court said the Food and Drug Administration cannot approve the generics made by Dr. Reddy's and Par until Feb. 2, 2025, and that the agency can't approve the Alphapharm generic until Aug. 14, 2017.
Treximet is a combination of GlaxoSmithKline PLC's drug Imitrex and an anti-inflammatory drug developed by Pozen. GlaxoSmithKline markets the drug and pays royalties to Pozen. In the second quarter, those royalty payments accounted for $4 million of Pozen's $4.6 million in total revenue.
The FDA approved Treximet in April 2008 after years of delays, and Par filed for approval of its generic in October of that year.
Pozen said the U.S. District Court for the Eastern District of Texas ruled that the patents were valid. The court also found that generic versions of Treximet developed by Par Pharmaceutical Co. and Dr. Reddy's Laboratories Ltd. infringed on all three patents, while a version developed by Alphapharm Pty Ltd. infringed on two patents. Teva Pharmaceutical Industries Ltd. had also challenged the patents, but was dismissed from Pozen's lawsuit in April 2010 after it agreed to abide by the court's decision.
The court said the Food and Drug Administration cannot approve the generics made by Dr. Reddy's and Par until Feb. 2, 2025, and that the agency can't approve the Alphapharm generic until Aug. 14, 2017.
Treximet is a combination of GlaxoSmithKline PLC's drug Imitrex and an anti-inflammatory drug developed by Pozen. GlaxoSmithKline markets the drug and pays royalties to Pozen. In the second quarter, those royalty payments accounted for $4 million of Pozen's $4.6 million in total revenue.
The FDA approved Treximet in April 2008 after years of delays, and Par filed for approval of its generic in October of that year.