FDA Orange Book

Generic for Otezla

Otezla contains apremilast. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Otezla is apremilast. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Otezla products in the Orange Book

Otezla products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	5	AB
tablet, oral	20MG	Marketed (Rx)	AB	5	AB
tablet, oral	30MG	Marketed (Rx)	AB	5	AB

NDA 205437, held by AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic apremilast

Approved generic versions of Otezla
Company	ANDA	TE code	Approved	Strengths
ALKEM LABORATORIES LTD	211761	AB (A-rated, therapeutically equivalent)	September 21, 2021	10MG, 20MG, 30MG
SHILPA MEDICARE LTD	211774	AB (A-rated, therapeutically equivalent)	April 7, 2023	10MG, 20MG, 30MG
ANNORA PHARMA PRIVATE LTD	211878	AB (A-rated, therapeutically equivalent)	July 26, 2023	10MG, 20MG, 30MG
MANKIND PHARMA LTD	211734	AB (A-rated, therapeutically equivalent)	February 7, 2024	10MG, 20MG, 30MG
MSN LABORATORIES PRIVATE LTD	211887	AB (A-rated, therapeutically equivalent)	December 16, 2024	10MG, 20MG, 30MG

Otezla patents

Patents listed for Otezla
Patent	Expires	Covers	Use code	NDA
7427638	February 16, 2028	Drug substance, Drug product	None	205437
7427638*PED	August 16, 2028	Method of use	None	205437
12576034	November 30, 2033	Drug product	U-4291	205437
12576034	November 30, 2033	Drug product	U-1858	205437
12576034	November 30, 2033	Drug product	U-4290	205437
10092541	May 29, 2034	Method of use	U-2403	205437
10092541	May 29, 2034	Method of use	U-2659	205437
9872854	May 29, 2034	Method of use	U-2232	205437
9872854	May 29, 2034	Method of use	U-2233	205437
12576034*PED	May 30, 2034	Method of use	None	205437
9872854*PED	November 29, 2034	Method of use	None	205437
10092541*PED	November 29, 2034	Method of use	None	205437

Otezla exclusivity

Exclusivity listed for Otezla
Code	Meaning	Expires	NDA
ODE-248	Orphan drug exclusivity	July 19, 2026	205437
M-299	Miscellaneous	July 20, 2026	205437
PED	Pediatric exclusivity	January 19, 2027	205437
PED	Pediatric exclusivity	January 20, 2027	205437
NPP	New patient population	April 25, 2027	205437
PED	Pediatric exclusivity	October 25, 2027	205437

Otezla NDC codes

Questions

Is there a generic for Otezla?

Yes. The generic name for Otezla is apremilast. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Otezla?

The active ingredient in Otezla is apremilast, per the FDA Orange Book.

When does the Otezla patent expire?

The last patent listed for Otezla in the Orange Book expires November 29, 2034. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.