Teva Pharmaceutical Industries Ltd., has announced the launch of generic Axert (almotriptan malate) tablets, 6.25 mg and 12.5 mg, in the United States. Axert is a drug to treat migraines. Teva says it was the first applicant to submit an abbreviated new drug application (ANDA) for almotriptan malate tablets containing a Paragraph IV patent certification.

The ANDA for almotriptan malate tablets submitted by Teva to the US Food and Drug Administration on December 7, 2005, was the first ANDA submitted by a generic company containing a Paragraph IV certification for Janssen Pharmaceuticals Axer, according to Teva. Teva is the first applicant to receive approval and will have a period of market exclusivity until the pediatric exclusivity associated with the only patent for Axert expires on November 7, 2015, according to Teva.

Axert tablets, marketed by Janssen Pharmaceuticals, had annual sales of approximately $31 million in the United States, according to IMS data as of March 2015, and as reported by Teva.

Source: Teva Pharmaceutical Industries