small molecule

LEQVIO

INCLISIRAN SODIUM

Loss of exclusivityAugust 2036latest FDA-listed patent expiry
CompanyNovartis →See this company's full patent-cliff portfolio

Drug detail

Brand nameLEQVIO
Active ingredientINCLISIRAN SODIUM
StrengthEQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalDecember 2021
Marketing statusRX

Listed patents

PatentExpiresType
10851377August 2036use U-4249
10125369August 2034substance, product
12460206August 2034substance, product
8106022December 2029substance, product
10806791December 2028substance
9370582December 2028substance, product
8828956December 2028substance, product
10131907August 2028substance, product
8222222December 2027use U-4414
8809292May 2027substance, product

Regulatory exclusivity

CodeExpires
ODE-555February 2033
I-985February 2029
NPPFebruary 2029
NCEDecember 2026

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.