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Last Updated: June 24, 2021

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OTEZLA Drug 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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-one 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. Two suppliers are 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 UNICHEM on February 17th, 2021.

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Drug patent expirations by year for OTEZLA
Drug Prices for OTEZLA

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Recent Clinical Trials for OTEZLA

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

SponsorPhase
Boehringer IngelheimPhase 1
University of Erlangen-Nürnberg Medical SchoolPhase 3
University of California, San FranciscoPhase 2

See all OTEZLA clinical trials

Pharmacology for OTEZLA
Paragraph IV (Patent) Challenges for OTEZLA
Tradename Dosage Ingredient NDA Submissiondate
OTEZLA TABLET;ORAL apremilast 205437 2018-03-22

US Patents and Regulatory Information for OTEZLA

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 205437-003 Mar 21, 2014 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 205437-001 Mar 21, 2014   Try Before You Buy   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014   Try Before You Buy   Try Before You Buy
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for OTEZLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 132019000000096 Italy   Try Before You Buy PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690 C20190029 00295 Estonia   Try Before You Buy PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 365 14-2019 Slovakia   Try Before You Buy PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116
2962690 2019/037 Ireland   Try Before You Buy PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 CA 2019 00033 Denmark   Try Before You Buy PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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