small molecule

PYRUKYND

MITAPIVAT SULFATE

Loss of exclusivityJuly 2041latest FDA-listed patent expiry
CompanyAgios PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand namePYRUKYND
Active ingredientMITAPIVAT SULFATE
StrengthEQ 5MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2022
Marketing statusRX

Listed patents

PatentExpiresType
11878049July 2041use U-3782
11254652November 2038substance, product
11234976October 2038use U-3321
RE49582April 2035substance, product
11793806April 2033use U-3320
9193701October 2032use U-3319
10632114May 2032use U-3320
9682080May 2032use U-3319
9980961May 2032use U-3319

Regulatory exclusivity

CodeExpires
ODE-392February 2029
NCEFebruary 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.

PYRUKYND patent cliff — loss of exclusivity July 2041 | CliffBio