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Last Updated: July 6, 2020

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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 eighty-nine patent family members in twenty-three 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.

US ANDA Litigation and Generic Entry Outlook for Otezla

Otezla was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 16, 2028. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (apremilast), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for OTEZLA
Drug Prices for OTEZLA

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Generic Entry Opportunity Date for OTEZLA
Generic Entry Date for OTEZLA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OTEZLA

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

SponsorPhase
Tufts Medical CenterPhase 2
AmgenPhase 2
Dermatology Department University Hospital FrankfurtPhase 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 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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 205437-001 Mar 21, 2014   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014   Start Trial   Start Trial
>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 CA 2019 00033 Denmark   Start Trial PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 132019000000096 Italy   Start Trial PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690 2019/037 Ireland   Start Trial PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 C20190029 00295 Estonia   Start Trial PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKesson
Medtronic
Baxter
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.