small molecule

AMELUZ

AMINOLEVULINIC ACID HYDROCHLORIDE

Loss of exclusivityDecember 2043latest FDA-listed patent expiry
CompanyBiofrontera →See this company's full patent-cliff portfolio

Drug detail

Brand nameAMELUZ
Active ingredientAMINOLEVULINIC ACID HYDROCHLORIDE
Strength10%
Dosage formGEL
RouteTOPICAL
ModalitySmall molecule
FDA approvalMay 2016
Marketing statusRX

Listed patents

PatentExpiresType
12280146December 2043product
11235169October 2040use U-3303
11540981February 2028product

Regulatory exclusivity

CodeExpires
D-194October 2027

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.