You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Merck
AstraZeneca
McKinsey
Colorcon

Last Updated: February 17, 2020

DrugPatentWatch Database Preview

OTEZLA Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

When do Otezla patents expire, and what generic alternatives are available?

Otezla is a drug marketed by Celgene Corp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-eight 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. One supplier is 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 eight 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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for OTEZLA
Drug Prices for OTEZLA

See drug prices for OTEZLA

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
Dr. Frank BehrensPhase 2
Dermatology Department University Hospital FrankfurtPhase 2
Oslo University HospitalPhase 2

See all OTEZLA clinical trials

Recent Litigation for OTEZLA

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.2019-07-12
Celgene Corporation v. Amneal Pharmaceuticals LLC2018-07-12
Celgene Corporation v. Aurobindo Pharma Limited2018-07-06

See all OTEZLA litigation

Pharmacology for OTEZLA
Synonyms for OTEZLA
(+)-N-(2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxo- 2,3-dihydro-1H-isoindol-4-yl)acetamide
(S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
(S)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione(Apremilast)
(S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
(S)-N-{2-[1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}-acetamide
4-[[5 pound not7-dihydroxy-2 pound not2-dimethyl-8-(2-methylpropanoyl)chromen-6-yl]methy l]-3 pound not5-dihydroxy-6 pound not6-dimethyl-2-(2-methylpropanoyl)cyclohexa-2 pound not4-dien- 1-one
608141-41-9
666854-78-0
AB0093139
AC-27650
Acetamide, N-(2-((1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)- 2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)-
AJ-84147
AKOS016339660
AOB87775
Apremilast
Apremilast (CC-10004)
Apremilast (JAN/USAN)
Apremilast [USAN:INN]
Apremilast/CC 10004/
apremilastum
BC600507
BCP03783
BCP0726000109
BCP25283
BCP9000311
BDBM50248919
C22H24N2O7S
cas:608141-41-9;Apremilast
CC 10004
CC-10004
CC10004
CHEBI:78540
CHEMBL514800
CS-0671
D08860
DB05676
EX-A336
FK-0727
FT-0700081
GTPL7372
HSDB 8221
HY-12085
IMOZEMNVLZVGJZ-QGZVFWFLSA-N
KB-74720
MolPort-023-219-158
N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-1,3-dioxoisoindol-4-yl]acetamide
N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide
N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide
Otezla (TN)
QCR-202
S-7765
s8034
SB16492
SC-95443
SCHEMBL302992
SW219856-1
UNII-N5UK68MGDZ component IMOZEMNVLZVGJZ-QGZVFWFLSA-N
UNII-UP7QBP99PN
UP7QBP99PN
Y0437
ZINC30691736
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
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No   Start Trial   Start Trial   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
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014   Start Trial   Start Trial
Celgene Corp 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 132019000000096 Italy   Start Trial PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690 2019C/008 Belgium   Start Trial PRODUCT NAME: APREMILAST,OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
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 122019000070 Germany   Start Trial 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Harvard Business School
Express Scripts
Merck
Medtronic

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 verifification 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.