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Teva first to receive approval and launch generic Axert tablets in the US
9 July 2015 • Author: Victoria White
Teva has launched generic Axert® (almotriptan malate) tablets, 6.25 mg and 12.5 mg, in the US.
Almotriptan malate tablets are a 5HT1B/1D receptor agonist (triptan) indicated for acute treatment of migraine attacks in adults and adolescents with a history of migraine with or without aura.
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 7 December 2005, was the first ANDA submitted by a generic company containing a Paragraph IV certification for Janssen Pharmaceuticals’ Axert. 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. 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 7 November 2015.
Generic Axert adds to Teva’s portfolio of over 375 generic medicines
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 United States, according to IMS data as of March 2015.
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