The US Food and Drug Administration is facing another round of lawsuits over its marketing exclusivity decisions. Alvogen contends Teva forfeited its 180-day marketing exclusivity for a generic version of the opioid treatment Belbuca (buprenorphine buccal film). And Sandoz claims Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) does not qualify for new chemical entity exclusivity.
Two Firms Fight FDA Exclusivity Battles In US
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.
