small molecule

OTEZLA XR

APREMILAST

Loss of exclusivityMay 2042latest FDA-listed patent expiry

CompanyAmgen →See this company's full patent-cliff portfolio

Drug detail

Brand name	OTEZLA XR
Active ingredient	APREMILAST
Strength	75MG
Dosage form	TABLET, EXTENDED RELEASE
Route	ORAL
Modality	Small molecule
FDA approval	August 2025
Marketing status	RX

Listed patents

Patent	Expires	Type
11752129	May 2042	product
12427136	May 2042	use U-4291
11969409	May 2042	product
10092541	May 2034	use U-2659
7427638	February 2028	substance, product

Regulatory exclusivity

Code	Expires
PED	January 2027
PED	January 2027
M-299	July 2026
ODE*	July 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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