13 July 2015Americas

Teva first to launch generic Axert

Pharmaceutical company Teva has become the first business to launch a generic version of Janssen Pharmaceuticals’s migraine treatment drug Axert (almotriptan malate).

According to Israel-based Teva, it has launched 6.25 mg and 12.5 mg tablets in the US.

The generic version was launched on July 8.

Teva had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) in 2005 containing a Paragraph IV patent certification.

According to Teva, its application was the first ANDA submitted for Axert. Now that the generic has been approved, Teva will have a period of market exclusivity lasting until November 7 this year.

Andrew Williams, partner at law firm McDonnell Boehnen Hulbert & Berghoff in Chicago, said Janssen has only one patent related to Axert listed in the FDA’s Orange Book, US number 5,565,447, which it asserted against Teva in March 2006 after the Israel-based company filed its ANDA.

But, said Williams, the case ended in 2008 after Teva agreed to dismiss its claims that the patent was invalid.

Williams added that Teva was enjoined from manufacturing or marketing its generic until a predetermined but undisclosed date, which "must have now passed".

“Teva will benefit from a paediatric exclusivity period associated with the ‘447 patent. Even though the patent expired in May this year, this exclusivity period prevents the FDA from approving any generic drugs related to Axert without Janssen’s consent.

“Teva was only able to receive final approval from the FDA because Janssen provided it with a letter that waived this paediatric exclusivity period, presumably as part of the settlement agreement. Therefore, unless Janssen waives this period for another ANDA filer, Teva will be the sole marketer of generic Axert until at least November 7," Williams said.

He added: “It might not be until the end of this year that the final picture for the generic landscape of this drug will become clear.”

The company said in a statement: “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.”

According to pharma information service IMS Health, in March 2015 Axert had generated annual sales of approximately $31 million in the US.

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