small molecule

OZEMPIC

SEMAGLUTIDE

Loss of exclusivityApril 2037latest FDA-listed patent expiry
CompanyNOVO NORDISK INC

Drug detail

Brand nameOZEMPIC
Active ingredientSEMAGLUTIDE
Strength4MG/3ML (1.34MG/ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalApril 2019
Marketing statusRX

Listed patents

PatentExpiresType
12569543April 2037use U-4446
10335462June 2033use U-2580
9132239February 2032product
8129343December 2031substance, product
9457154September 2027product
9687611February 2027product
RE46363August 2026product
9775953July 2026product
8920383July 2026product
10220155July 2026product
11097063July 2026product
8536122March 2026substance, product
10357616January 2026product
10376652January 2026product
9108002January 2026product
9616180January 2026product
9861757January 2026product

Regulatory exclusivity

CodeExpires
I-961January 2028

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.

OZEMPIC patent cliff — loss of exclusivity April 2037 | CliffBio