small molecule

SEPHIENCE

SEPIAPTERIN

Loss of exclusivityMarch 2042latest FDA-listed patent expiry

CompanyPTC Therapeutics →See this company's full patent-cliff portfolio

Drug detail

Brand name	SEPHIENCE
Active ingredient	SEPIAPTERIN
Strength	250MG/PACKET
Dosage form	POWDER
Route	ORAL
Modality	Small molecule
FDA approval	July 2025
Marketing status	RX

Listed patents

Patent	Expires	Type
12257252	March 2042	use U-4250
12213982	September 2038	use U-4251
11752154	September 2038	product
11072614	April 2038	substance

Regulatory exclusivity

Code	Expires
ODE-542	July 2032
NCE	July 2030

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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