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Last Updated: October 31, 2024

OTEZLA Drug Patent Profile


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When do Otezla patents expire, and when can generic versions of Otezla launch?

Otezla is a drug marketed by Amgen Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in twenty-four countries.

The generic ingredient in OTEZLA is apremilast. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Otezla

A generic version of OTEZLA was approved as apremilast by ALKEM LABS LTD on September 21st, 2021.

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Drug patent expirations by year for OTEZLA
Drug Prices for OTEZLA

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Recent Clinical Trials for OTEZLA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
AmgenEarly Phase 1
Robert MichelettiPhase 2

See all OTEZLA clinical trials

Pharmacology for OTEZLA
Paragraph IV (Patent) Challenges for OTEZLA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OTEZLA Tablets apremilast 10 mg, 20 mg and 30 mg 205437 11 2018-03-22

US Patents and Regulatory Information for OTEZLA

OTEZLA is protected by three US patents and seven FDA Regulatory Exclusivities.

Patents protecting OTEZLA

Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

(+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting OTEZLA

TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
Exclusivity Expiration: ⤷  Sign Up

REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OTEZLA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for OTEZLA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amgen Europe BV Otezla apremilast EMEA/H/C/003746
Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Authorised no no no 2015-01-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OTEZLA

See the table below for patents covering OTEZLA around the world.

Country Patent Number Title Estimated Expiration
Japan 5936521 ⤷  Sign Up
China 101683334 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof ⤷  Sign Up
South Korea 101383845 ⤷  Sign Up
China 1965823 Preparing methods of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione and its compound ⤷  Sign Up
Denmark 1126839 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OTEZLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 C20190029 00295 Estonia ⤷  Sign Up PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 C 2019 032 Romania ⤷  Sign Up PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690 SPC/GB19/045 United Kingdom ⤷  Sign Up PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116
2962690 300994 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2962690 2019C/008 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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