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Last Updated: December 6, 2022

Apremilast - Generic Drug Details


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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, Teva Pharms Usa Inc, Unichem, and Amgen Inc, and is included in five NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-eight drug master file entries for apremilast. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for apremilast

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

SponsorPhase
University Hospital, RouenPhase 3
AbbViePhase 3
Boehringer IngelheimPhase 1

See all apremilast clinical trials

Generic filers with tentative approvals for APREMILAST
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing30MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing20MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;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
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 See Plans and Pricing See Plans and Pricing
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 See Plans and Pricing See Plans and Pricing
>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 arthritis, , Otezla, 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., , Psoriasis, , Otezla 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
Denmark 1485087 See Plans and Pricing
Cyprus 1121720 See Plans and Pricing
Israel 207149 (+)-2-[1-(3-אתוקסי-4-מתוקסיפניל)-2-מתילסולפונילאתיל]-4-אצטילאמינו איזואינדולין-3,1-דיאון, פולימורף רוקחי מקובל, מלח, סולבאט או הידראט שלו לשימוש בטיפול במחלה אוטואימונית, באופן ברירתי יחד עם תרופה נוגדת דלקת ((+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutical acceptable polymorph, salt, solvate or hydrate thereof for use in treating an autoimmune disease, optionally in combination with an anti-inflammatory drug) See Plans and Pricing
Slovenia 2223687 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for apremilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 CA 2019 00033 Denmark See Plans and Pricing PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 122019000070 Germany See Plans and Pricing PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 C20190029 00295 Estonia See Plans and Pricing PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 C 2019 032 Romania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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