Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, announced the launch of generic Axert (almotriptan malate) tablets, 6.25 mg and 12.5 mg, in the United States. 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 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' Axert. Teva is the first applicant to receive approval and will have a period of market exclusivity until the paediatric exclusivity associated with the only patent for Axert expires on November 7, 2015.
Teva continues to deliver on its generics business strategy and remains focused on increasing its first to file regulatory submissions in the United States. With over 375 generic medicines available, Teva has the largest portfolio of safe, effective, FDA-approved generic products on the market.
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.
Paragraph IV certification provides opportunities for generic manufacturers to launch the generic version of a brand drug before the expiration of the brand drug’s patents are listed in the orange book, which requires generics manufacturers 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.