small molecule

ZEPZELCA

LURBINECTEDIN

Loss of exclusivityMay 2040latest FDA-listed patent expiry
CompanyJAZZ PHARMACEUTICALS IRELAND LTD

Drug detail

Brand nameZEPZELCA
Active ingredientLURBINECTEDIN
Strength4MG/VIAL
Dosage formPOWDER
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalJune 2020
Marketing statusRX

Listed patents

PatentExpiresType
12324806May 2040use U-4212
12433890May 2040use U-4305
12440490May 2040use U-4252
7763615December 2029substance, product

Regulatory exclusivity

CodeExpires
I-977October 2028
ODE-304June 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.

ZEPZELCA patent cliff — loss of exclusivity May 2040 | CliffBio