US Aubagio patent challenge confirmed

6 January 2017

US generic drugmaker Impax Laboratories (Nasdaq: IPXL) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration containing a paragraph IV certification for a generic version of Aubagio (teriflunomide), a leading multiple sclerosis treatment marketing by French pharma major Sanofi (Euronext: SAN).

The plaintiffs, Sanofi-Aventis US, Sanofi and its subsidiary Genzyme filed suit for patent infringement against Impax in the US District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

According to IMS Health (NSP) data quoted by Impax, US sales of Aubagio tablets, 14mg, were around $1.1 billion for the 12 months ended November 2016.

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