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Last Updated: November 30, 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 205437-002 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
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
Amneal APREMILAST apremilast TABLET;ORAL 211782-003 Jun 30, 2021 DISCN No 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 Y Y 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 205437-001 Mar 21, 2014 See Plans and Pricing See Plans and Pricing
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 205437-003 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
Cyprus 1109380 See Plans and Pricing
Spain 2637547 See Plans and Pricing
Hungary S1900032 See Plans and Pricing
New Zealand 535798 (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof See Plans and Pricing
World Intellectual Property Organization (WIPO) 2014151180 See Plans and Pricing
Slovenia 2223688 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 C02962690/01 Switzerland See Plans and Pricing VERTRETERLOESCHUNG
2962690 SPC/GB19/045 United Kingdom See Plans and Pricing 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 37/2019 Austria See Plans and Pricing PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690 LUC00125 Luxembourg See Plans and Pricing PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690 2019C/008 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
2962690 122019000070 Germany See Plans and Pricing PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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