Loss of exclusivityDecember 2028FDA regulatory exclusivity expiry
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Drug detail
Brand name
ADDYI
Active ingredient
FLIBANSERIN
Strength
100MG
Dosage form
TABLET
Route
ORAL
Modality
Small molecule
FDA approval
August 2015
Marketing status
RX
Listed patents
Patent
Expires
Type
7151103
May 2028
use U-1734
Regulatory exclusivity
Code
Expires
I-983
December 2028
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.
ADDYI patent cliff — loss of exclusivity December 2028 | CliffBio