Teva first to get approval and launch generic Axert in the USA

9 July 2015

Israel-based generics giant Teva Pharmaceutical Industries (NYSE: TEVA) has launched its generic version of the migraine drug Axert (almotriptan malate) tablets, 6.25mg and 12.5mg, in the USA.

Teva was the first applicant to submit an Abbreviated New Drug Application (ANDA) for almotriptan malate tablets containing a Paragraph IV patent certification. Axert is marketed in the USA under license from Spain’s Almirall by Janssen Pharmaceuticals, a unit of health care giant Johnson & Johnson (NYSE: JNJ), and had annual sales of around $31 million in the USA, according to IMS data as of March 2015 quoted by Teva.

Period of exclusivity until patent expires on November 7

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