Teva First to Receive Approval and Launch Generic Axert Tablets in the US

Teva Pharmaceutical Industries has announced the launch of generic Axert (almotriptan malate) tablets, 6.25 mg and 12.5 mg, in the US. Teva 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 FDA on 7 December 2005, was the first ANDA submitted by a generic company containing a Paragraph IV certification for Janssen Pharmaceuticals Axert. 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 7 November 2015.

Teva continues to deliver on its generics business strategy and remains focused on increasing its first to file regulatory submissions in the US. With over 375 generic medicines available, Teva has the largest portfolio of safe, effective, FDA-approved generic products on the market.

Axert (almotriptan malate) tablets, marketed by Janssen Pharmaceuticals, had annual sales of approximately $31 million in the US, according to IMS data as of March 2015.