small molecule

ZAYNICH

CEFEPIME HYDROCHLORIDE; ZIDEBACTAM

Loss of exclusivityMay 2036FDA regulatory exclusivity expiry
CompanyWOCKHARDT BIO AG

Drug detail

Brand nameZAYNICH
Active ingredientCEFEPIME HYDROCHLORIDE; ZIDEBACTAM
StrengthEQ 2GM BASE/VIAL;1GM/VIAL
Dosage formPOWDER
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalMay 2026
Marketing statusRX

Listed patents

PatentExpiresType
9657021October 2033substance
9834557October 2033substance
8822450August 2032substance, product
9132133August 2032use U-4558
8853197August 2032substance
9381200August 2032product
9827235August 2032product

Regulatory exclusivity

CodeExpires
GAINMay 2036
NCEMay 2031

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.