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FDA’s Orphan Exclusivity Requirement For “Clinical Superiority” Challenged In Court

This article was originally published in The Pink Sheet Daily

Executive Summary

Depomed argues in a suit against FDA that it should not have to show Gralise (gabapentin) is clinically superior to Neurontin since Neurontin never received an orphan drug designation or orphan exclusivity.

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FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change

FDA bows to a court ruling requiring it to award orphan drug market exclusivity to Depomed’s gabapentin, but the agency says it will continue to require the sponsor of a drug that is the “same” as a previously approved drug to show that it is “clinically superior” in order to be eligible.

FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact

A district court rejects FDA’s “clinical superiority” requirement for Gralise orphan exclusivity, while another court upholds the agency’s finding that an ANDA label carve-out may overlap partially with a protected method of use.

Plausibility Takes A Hit: FDA Revokes Orphan Exclusivity For Octapharma’s Wilate

In the first-ever rescission of marketing exclusivity for an orphan drug, FDA concludes that data does not show Wilate is superior to CSL Behring’s Factor VIII drug Humate-P. Wilate had previously been awarded orphan drug exclusivity for the same indication because of a “plausible hypothesis” that it was safer.


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