FDA Expects More Litigation Over Generic Exclusivity

A senior FDA attorney has admitted that Teva’s successful challenge of the agency’s policy for withdrawing a generic-drug maker’s exclusivity period caught the FDA off-guard and predicted the issue is almost certain to come up again. The case in question took place earlier this year when the U.S. Court of Appeals for the District of Columbia Circuit overturned FDA precedent and ruled that any unilateral action by a brand-drug maker, such as delisting a patent or letting it expire, cannot be used as a means for canceling a generic-drug maker’s 180-day exclusivity period.
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