First Generic Axert Migraine Treatment Launched by Teva

Teva has launched the first generic version of Janssen’s Axert migraine treatment.

The Abbreviated New Drug Application (ANDA) for Teva’s almotriptan malate tablets was submitted to the FDA on December 7, 2005. This ANDA contained a Paragraph IV patent certification, which allows drug manufacturers to launch generic versions of brand-name medications before their patents expire.

As the first applicant to receive approval, Teva has market exclusivity until the pediatric exclusivity associated with Axert’s only patent expires on November 17, 2015.

Almotriptan malate is indicated to treat migraine headaches in adults and adolescents with a history of migraine with or without aura. The drug should not be used to treat common tension headaches.

Axert had annual US sales of $31 million as of March 2015, according to IMS data.