small molecule

ORSERDU

ELACESTRANT HYDROCHLORIDE

Loss of exclusivityJanuary 2038latest FDA-listed patent expiry
CompanyStemline TherapeuticsSee this company's full patent-cliff portfolio

Drug detail

Brand nameORSERDU
Active ingredientELACESTRANT HYDROCHLORIDE
StrengthEQ 86MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJanuary 2023
Marketing statusRX

Listed patents

PatentExpiresType
10745343January 2038use U-3523
10385008January 2038substance, product
11819480February 2037use U-3523
10420734October 2036use U-3524
10071066October 2034use U-3524
11779552October 2034use U-3524
7612114August 2026substance, product

Regulatory exclusivity

CodeExpires
NCEJanuary 2028

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.

ORSERDU patent cliff — loss of exclusivity January 2038 | CliffBio