CliffBio
small molecule

AZSTARYS

DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

Loss of exclusivityDecember 2037latest FDA-listed patent expiry
CompanyCOMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC

Drug detail

Brand nameAZSTARYS
Active ingredientDEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
StrengthEQ 5.2MG BASE;EQ 26.1MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalMay 2021
Marketing statusRX

Listed patents

PatentExpiresType
10858341December 2037use U-3094
10954213December 2037use U-3094
10584112December 2037substance, product
10584113December 2037product
10759778December 2037product
9079928May 2035product

Regulatory exclusivity

CodeExpires
NCEMay 2026

More from COMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC

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.

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