Novartis sues FDA over its stance on Sanofi blockbuster’s exclusivity
Novartis’ generic drug subsidiary Sandoz has sued the FDA, claiming the agency is wrongly protecting Sanofi’s blockbuster multiple sclerosis drug Aubagio from generic competition.
At issue is what’s known as new chemical entity (NCE) exclusivity, which is meant to reward drug developers with five years of no competition as long as the active ingredient in the rewarded drug is actually new.
In this case, Sandoz is contending that the active ingredient in Aubagio – teriflunomide — has previously been approved in the rheumatoid arthritis drug Arava, and that FDA is wrongfully claiming that this ingredient is just an impurity in Arava.
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