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NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency

 
• By Brenda Sandburg

Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.

For the second time in a month FDA is being asked to change its exclusivity policy so that drug combinations containing at least one new active ingredient qualify for five years of market exclusivity.

Ferring Pharmaceuticals Inc. filed a citizen petition with FDA on Jan. 29 seeking five-year exclusivity for Prepopik,...

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