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Last Updated: March 19, 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

See drug prices for OTEZLA

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 10 2018-03-22

US Patents and Regulatory Information for OTEZLA

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

Patents protecting OTEZLA

Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE

Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE

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

Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE

Methods for the treatment of psoriatic arthritis using apremilast
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT

FDA Regulatory Exclusivity protecting OTEZLA

TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
Exclusivity Expiration: ⤷  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
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes 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
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes 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 OTEZLA

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 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
Denmark 2223688 ⤷  Try a Trial
Hong Kong 1219049 -乙氧基- -甲氧基苯基 -甲磺醯基乙基 -乙醯氨基異吲哚啉- -二酮:其合成方法及其組合物 (()-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4- ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF () -2-[1-(3--4-)-2-]-4-- 13-) ⤷  Try a Trial
South Korea 20110022736 (+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE: METHODS OF USING AND COMPOSITIONS THEREOF ⤷  Try a Trial
Hungary E045489 ⤷  Try a Trial
Japan 2015013893 (+)−2−[1−(3−エトキシ−4−メトキシフェニル)−2−メチルスルホニルエチル]−4−アセチルアミノイソインドリン−1,3−ジオン、その使用方法及び組成物 ((+)-2-[1-(3-ETHOXY-4-METHOXYPHENYL)-2-METHYLSULFONYLETHYL]-4-ACETYLAMINOISOINDOLINE-1,3-DIONE, METHODS OF USING THE SAME, AND COMPOSITIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OTEZLA

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

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