small molecule

OTEZLA

APREMILAST

Loss of exclusivityNovember 2034latest FDA-listed patent expiry

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

Drug detail

Brand name	OTEZLA
Active ingredient	APREMILAST
Strength	20MG
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	March 2014
Marketing status	RX

Listed patents

Patent	Expires	Type
10092541*PED	November 2034	—
9872854*PED	November 2034	—
12576034*PED	May 2034	—
9872854	May 2034	use U-2233
10092541	May 2034	use U-2403
12576034	November 2033	product
7427638*PED	August 2028	—
7427638	February 2028	substance, product

Regulatory exclusivity

Code	Expires
PED	October 2027
NPP	April 2027
PED	January 2027
PED	January 2027
M-299	July 2026
ODE-248	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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