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 name	AZSTARYS
Active ingredient	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Strength	EQ 10.4MG BASE;EQ 52.3MG BASE
Dosage form	CAPSULE
Route	ORAL
Modality	Small molecule
FDA approval	May 2021
Marketing status	RX

Listed patents

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

Regulatory exclusivity

Code	Expires
NCE	May 2026

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.

Drug detail

Listed patents

Regulatory exclusivity

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