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Last Updated: October 7, 2024

APREMILAST - Generic Drug Details


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What are the generic sources for apremilast and what is the scope of freedom to operate?

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.

Summary for APREMILAST
Recent Clinical Trials for APREMILAST

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

SponsorPhase
TakedaPhase 3
Assiut UniversityPhase 1
Humanis Saglık Anonim SirketiPhase 3

See all APREMILAST clinical trials

Generic filers with tentative approvals for APREMILAST
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up30MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up20MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET;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 11 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
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys APREMILAST apremilast TABLET;ORAL 211756-001 Jul 14, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal APREMILAST apremilast TABLET;ORAL 211782-001 Jun 30, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd APREMILAST apremilast TABLET;ORAL 211716-003 Jul 19, 2023 DISCN No 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 Y ⤷  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 APREMILAST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 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 205437-003 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 205437-003 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
>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
South Korea 20100040938 (+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF ⤷  Sign Up
New Zealand 535798 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof ⤷  Sign Up
South Korea 20110022736 (+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF ⤷  Sign Up
South Korea 20050012722 ⤷  Sign Up
Australia 2003224729 (+)-2-(1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL)-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APREMILAST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 365 14-2019 Slovakia ⤷  Sign Up PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
2962690 CA 2019 00033 Denmark ⤷  Sign Up PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
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 300994 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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