Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
Argus Health
US Army
Covington
AstraZeneca
Teva
Healthtrust
Boehringer Ingelheim

Generated: September 24, 2018

DrugPatentWatch Database Preview

OTEZLA Drug Profile

« Back to Dashboard

When do Otezla patents expire, and when can generic versions of Otezla launch?

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.

The generic ingredient in OTEZLA is apremilast. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

Drug patent expirations by year 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.

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(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
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
AK151389
AKOS016339660
AOB87775
Apremilast
Apremilast (CC-10004)
Apremilast (JAN/USAN)
Apremilast [USAN:INN]
Apremilast/CC 10004/
apremilastum
BC600507
BCP0726000109
BCP9000311
BDBM50248919
C22H24N2O7S
cas:608141-41-9;Apremilast
CC 10004
CC-10004
CC10004
CHEBI:78540
CHEMBL514800
CS-0671
D07ESC
D08860
DB05676
EX-A336
FK-0727
FT-0700081
GTPL7372
HE224053
HSDB 8221
HY-12085
IMOZEMNVLZVGJZ-QGZVFWFLSA-N
KB-74720
MFCD18782607
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
SC-95443
SCHEMBL302992
UNII-N5UK68MGDZ component IMOZEMNVLZVGJZ-QGZVFWFLSA-N
UNII-UP7QBP99PN
UP7QBP99PN
Y0437
ZINC30691736

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Paragraph IV (Patent) Challenges for OTEZLA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg, 20 mg and30 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for OTEZLA

Country Document Number Estimated Expiration
South Korea 20150126618 ➤ Try a Free Trial
Norway 319790 ➤ Try a Free Trial
South Korea 101104991 ➤ Try a Free Trial
Cyprus 1107499 ➤ Try a Free Trial
South Korea 20120024938 ➤ Try a Free Trial
Germany 60328974 ➤ Try a Free Trial
South Korea 20050012722 ➤ Try a Free Trial
Country Document Number Estimated Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
Argus Health
US Army
Covington
AstraZeneca
Teva
Healthtrust
Boehringer Ingelheim

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.