US FDA Exclusivity Battles Continue: Alvogen and Sandoz Challenge Buprenorphine, Aubagio Awards
Alvogen contends Teva forfeited 180-day exclusivity with its settlement, while Sandoz claims Sanofi’s MS drug Aubagio isn’t an NCE because it is an active metabolite.
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DC Circuit Court upholds FDA’s grant of new chemical entity exclusivity to Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) even though the agency had previously approved teriflunomide as an impurity in Sanofi’s Arava (leflunomide). FDA reviews known impurities in drugs only to assess their impact on safety and efficacy, not to approve them, court says.
Collegium has offered a 54% share premium to acquire competitor BioDelivery, in an offer approved by both firm’s boards. The $604m price tag would double the size of Collegium’s product portfolio.
Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.