You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Apremilast - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for apremilast and what is the scope of patent protection?

Apremilast is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Mankind Pharma, Shilpa, Teva Pharms Usa Inc, Unichem, and Amgen Inc, and is included in eleven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apremilast has ninety patent family members in twenty-four countries.

There are twenty-eight drug master file entries for apremilast. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for apremilast

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

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

See all apremilast clinical trials

Generic filers with tentative approvals for APREMILAST
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial30MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for apremilast

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem APREMILAST apremilast TABLET;ORAL 211819-001 Feb 17, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd APREMILAST apremilast TABLET;ORAL 211716-001 Jul 19, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Annora APREMILAST apremilast TABLET;ORAL 211878-003 Jul 26, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma APREMILAST apremilast TABLET;ORAL 211734-003 Feb 7, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 apremilast

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

EU/EMA Drug Approvals for apremilast

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 apremilast

Country Patent Number Title Estimated Expiration
Japan 2005525386 ⤷  Try a Trial
Slovenia 2962690 ⤷  Try a Trial
Australia 2014235273 Treatment of psoriatic arthritis using apremilast ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2014151180 ⤷  Try a Trial
European Patent Office 2962690 (+)-2-[1-(3-ÉTHOXY-4-MÉTHOXYPHÉNYL)-2-MÉTHYLSULFONYLÉTHYL]-4-ACÉTYLAMINOISOINDOLINE-1,3-DIONE: SES PROCÉDÉS D'UTILISATION ET COMPOSITIONS CORRESPONDANTES ((+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for apremilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 2019/037 Ireland ⤷  Try a Trial PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 C201930044 Spain ⤷  Try a Trial PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
2962690 1990037-2 Sweden ⤷  Try a Trial PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116
2962690 C20190029 00295 Estonia ⤷  Try a Trial PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 LUC00125 Luxembourg ⤷  Try a Trial PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.