small molecule

FABHALTA

IPTACOPAN HYDROCHLORIDE

Loss of exclusivityJuly 2041latest FDA-listed patent expiry
CompanyNovartis →See this company's full patent-cliff portfolio

Drug detail

Brand nameFABHALTA
Active ingredientIPTACOPAN HYDROCHLORIDE
StrengthEQ 200MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2023
Marketing statusRX

Listed patents

PatentExpiresType
11951101July 2041use U-3895
12453726July 2041use U-4300
11603363May 2041substance, product
12384758May 2041use U-4161
11723901August 2038use U-3980
12285422August 2038use U-4181
10093663July 2034use U-3980
9682968July 2034substance, product

Regulatory exclusivity

CodeExpires
ODE-524March 2032
ODE-456December 2030
NCEDecember 2028
I-963March 2028
I-949August 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.