Teva First to Win FDA Nod for Generic Axert
Teva has launched a generic version of Janssen Pharmaceutical’s migraine drug Axert in the U.S., following receipt of FDA approval.
As the first to file an ANDA containing a Paragraph IV certification for Axert (almotriptan malate), Teva will enjoy market exclusivity until the pediatric exclusivity associated with the only patent for Axert expires on Nov. 7, 2015.
The patent was originally set to expire in May, but Spanish drugmaker Almirall — which owns the rights to Axert and markets it in the U.S. via Janssen — won an expanded indication in 2009 to treat migraines in adolescents.
The FDA first cleared Axert — a selective 5-hydroxytryptamine1B1D receptor agonist — for use in adults in 2001. The drug has annual sales of about $31 million, according to IMS data. — Kellen Owings