Teva Launches First Generic Axert Tablets in the US

Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States. According to the press release, Teva is the first applicant to submit an abbreviated new drug application (ANDA) for almotriptan malate tablets containing a Paragraph IV patent certification.

Paragraph IV certification provides opportunities for generic manufacturers to launch the generic version of a brand drug listed in the orange book before patent expiry. Generics manufacturers are required to certify that patents in the orange book are invalid, unenforceable, and/or the generic drug seeking to be approved will not infringe such patents.

The submission, which was filed on December 7, 2005, is 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 November 7, 2015.

Teva has a large portfolio of FDA-approved generic drugs on the market. The company hopes to continue delivering on its generics business strategy. Its focus is to increase first-to-file regulatory submissions in the US.

Axert is marketed by Janssen Pharmaceuticals and recorded annual sales of approximately $31 million in the US, according to March 2015 data from IMS.

Source: Teva