CliffBio
small molecule

XACDURO (COPACKAGED)

DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM

Loss of exclusivityNovember 2035latest FDA-listed patent expiry
CompanyEntasis Therapeutics →View the full company profile on CliffBio

Drug detail

Brand nameXACDURO (COPACKAGED)
Active ingredientDURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
StrengthEQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Dosage formPOWDER
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalMay 2023
Marketing statusRX

Listed patents

PatentExpiresType
10376499November 2035product
9968593November 2035product
9623014April 2033use U-2840
9309245April 2033substance

Regulatory exclusivity

CodeExpires
GAINMay 2033
NCEMay 2028

More from Entasis Therapeutics

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.

XACDURO (COPACKAGED) patent cliff — loss of exclusivity November 2035 | CliffBio