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Otezla

apremilast · Tablet, Film Coated

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Otezla
Generic name
apremilast
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Amgen, Inc
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Apremilast 20 mg/1 1492732 —
Apremilast 30 mg/1 1492732 —
Apremilast 75 mg/1 1492732 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Phosphodiesterase 4 Inhibitor [EPC] EPC 4 members — no class page
Phosphodiesterase 4 Inhibitors [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205437
Application type
NDA · New Drug Application
Approval date
March 21, 2014
Sponsor
AMGEN INC
Products on application
3
Submissions recorded
14
Products approved under application 205437.
Product Trade name Form Strength Ingredient Status TE Flags
205437-001 OTEZLA TABLET APREMILAST Prescription AB RLD
205437-002 OTEZLA TABLET APREMILAST Prescription AB RLD
205437-003 OTEZLA TABLET APREMILAST Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7427638 February 16, 2028 001 Yes April 15, 2014
7427638 February 16, 2028 002 Yes April 15, 2014
7427638 February 16, 2028 003 Yes April 15, 2014
7427638*PED August 16, 2028 001 No —
7427638*PED August 16, 2028 002 No —
7427638*PED August 16, 2028 003 No —
12576034 November 30, 2033 001 No U-4291 April 16, 2026
12576034 November 30, 2033 001 No U-1858 April 16, 2026
12576034 November 30, 2033 001 No U-4290 April 16, 2026
12576034 November 30, 2033 002 No U-4291 April 16, 2026
12576034 November 30, 2033 002 No U-1858 April 16, 2026
12576034 November 30, 2033 002 No U-4290 April 16, 2026
12576034 November 30, 2033 003 No U-4291 April 16, 2026
12576034 November 30, 2033 003 No U-1858 April 16, 2026
12576034 November 30, 2033 003 No U-4290 April 16, 2026
10092541 May 29, 2034 001 No U-2403 October 9, 2018
10092541 May 29, 2034 001 No U-2659 October 9, 2018
9872854 May 29, 2034 001 No U-2232 February 21, 2018
9872854 May 29, 2034 001 No U-2233 February 21, 2018
9872854 May 29, 2034 002 No U-2232 February 21, 2018
9872854 May 29, 2034 002 No U-2233 February 21, 2018
10092541 May 29, 2034 002 No U-2659 October 9, 2018
10092541 May 29, 2034 002 No U-2403 October 9, 2018
9872854 May 29, 2034 003 No U-2232 February 21, 2018
10092541 May 29, 2034 003 No U-2403 October 9, 2018
10092541 May 29, 2034 003 No U-2659 October 9, 2018
9872854 May 29, 2034 003 No U-2233 February 21, 2018
12576034*PED May 30, 2034 001 No —
12576034*PED May 30, 2034 002 No —
12576034*PED May 30, 2034 003 No —
9872854*PED November 29, 2034 001 No —
10092541*PED November 29, 2034 001 No —
9872854*PED November 29, 2034 002 No —
10092541*PED November 29, 2034 002 No —
9872854*PED November 29, 2034 003 No —
10092541*PED November 29, 2034 003 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-248 July 19, 2026 001
ODE-248 July 19, 2026 002
ODE-248 July 19, 2026 003
M-299 July 20, 2026 001
M-299 July 20, 2026 002
M-299 July 20, 2026 003
PED January 19, 2027 001
PED January 19, 2027 002
PED January 19, 2027 003
PED January 20, 2027 001
PED January 20, 2027 002
PED January 20, 2027 003
NPP April 25, 2027 001
NPP April 25, 2027 002
NPP April 25, 2027 003
PED October 25, 2027 001
PED October 25, 2027 002
PED October 25, 2027 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 205437.
Type No. Action Status Date Review
Supplement 16 Labeling Approved December 23, 2025 Standard
Supplement 14 Efficacy Approved July 23, 2025 Standard
Supplement 13 Efficacy Approved April 25, 2024 Priority
Supplement 12 Efficacy Approved July 20, 2023 Standard
Supplement 11 Efficacy Approved December 20, 2021 Standard
Supplement 8 Efficacy Approved April 10, 2020 Standard
Supplement 7 Efficacy Approved July 19, 2019 Standard
Supplement 6 Labeling Approved June 29, 2017 Standard
Supplement 5 Labeling Approved December 21, 2015 Standard
Supplement 4 Manufacturing (CMC) Approved April 27, 2015 Standard
Supplement 3 Manufacturing (CMC) Approved September 19, 2014 Standard
Supplement 2 Manufacturing (CMC) Approved July 28, 2014 Standard
Supplement 1 Manufacturing (CMC) Approved July 22, 2014 Standard
Original application 1 Type 1 - New Molecular Entity Approved March 21, 2014 Standard

Review documents

  • 0 · Supplement · February 24, 2026
  • 0 · Supplement · December 31, 2025
  • 0 · Supplement · December 30, 2025
  • 0 · Supplement · July 25, 2025
  • 0 · Supplement · July 25, 2025
  • 0 · Supplement · April 26, 2024
  • 0 · Supplement · April 26, 2024
  • 0 · Supplement · November 28, 2023
  • 0 · Supplement · July 21, 2023
  • 0 · Supplement · July 21, 2023
  • 0 · Supplement · December 21, 2021
  • 0 · Supplement · December 21, 2021
  • 0 · Supplement · April 13, 2020
  • 0 · Supplement · April 13, 2020
  • 0 · Supplement · July 22, 2019
  • 0 · Supplement · July 19, 2019
  • 0 · Supplement · July 5, 2017
  • 0 · Supplement · June 30, 2017
  • 0 · Supplement · December 28, 2015
  • 0 · Supplement · December 22, 2015
  • 0 · Original application · April 17, 2014
  • 0 · Original application · March 25, 2014
  • 0 · Original application · March 25, 2014

Adverse event reports

Source: openFDA FAERS
145,481
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: APREMILAST. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
55513-137-60 55513-137 Amgen, Inc 60 TABLET, FILM COATED in 1 BOTTLE (55513-137-60) February 26, 2020
55513-137-95 55513-137 Amgen, Inc 1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK February 26, 2020
55513-497-60 55513-497 Amgen, Inc 60 TABLET, FILM COATED in 1 BOTTLE (55513-497-60) April 27, 2024
55513-519-30 55513-519 Amgen, Inc 30 TABLET, FILM COATED in 1 BOTTLE (55513-519-30) August 31, 2025
55513-137 55513-137 Amgen, Inc — February 26, 2020
55513-497 55513-497 Amgen, Inc — April 25, 2024
55513-519 55513-519 Amgen, Inc — August 29, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.