small molecule

ZULRESSO

BREXANOLONE

Loss of exclusivityMarch 2037latest FDA-listed patent expiry
CompanySAGE THERAPEUTICS INC

Drug detail

Brand nameZULRESSO
Active ingredientBREXANOLONE
Strength100MG/20ML (5MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalJune 2019
Marketing statusDISCN

Listed patents

PatentExpiresType
10940156March 2037use U-2552
10251894November 2033use U-2552
10322139January 2033product
9750822March 2029product
7635773March 2029product
10117951March 2029product
8410077March 2029product
9200088March 2029product

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

ZULRESSO patent cliff — loss of exclusivity March 2037 | CliffBio