small molecule

MACRILEN

MACIMORELIN ACETATE

Loss of exclusivityJanuary 2030FDA regulatory exclusivity expiry
CompanyAEterna Zentaris →See this company's full patent-cliff portfolio

Drug detail

Brand nameMACRILEN
Active ingredientMACIMORELIN ACETATE
StrengthEQ 60MG BASE/POUCH
Dosage formFOR SOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2017
Marketing statusDISCN

Listed patents

PatentExpiresType
8192719*PEDApril 2028—
8192719October 2027use U-2220

Regulatory exclusivity

CodeExpires
PEDJanuary 2030
M-14July 2029

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.