← Patent-cliff monitor small molecule ONIVYDE IRINOTECAN HYDROCHLORIDE
Loss of exclusivity October 2036 latest FDA-listed patent expiry
Company IPSEN BIOPHARMACEUTICALS INC
Drug detail Brand name ONIVYDE Active ingredient IRINOTECAN HYDROCHLORIDE Strength EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) Dosage form INJECTABLE, LIPOSOMAL Route INTRAVENOUS Modality Small molecule FDA approval October 2015 Marketing status RX
Listed patents Patent Expires Type 10993914 October 2036 product 12059497 October 2036 product 10456360 October 2036 product 11344552 August 2036 use U-3824 11369597 June 2033 use U-1848 9339497 June 2033 use U-1848 9452162 June 2033 use U-1899 10980795 June 2033 use U-1848 9717724 June 2033 use U-1848 9492442 June 2033 use U-1848 9364473 June 2033 use U-1856 12364691 June 2033 use U-1848 8147867 August 2028 substance, product 8329213 January 2027 substance, product
Regulatory exclusivity Code Expires ODE-463 February 2031 I-932 February 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.