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Harvard Business School
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US Department of Justice

Generated: June 27, 2019

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OTEZLA Drug Profile

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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 seventy-six patent family members in twenty-one 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.

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
(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

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 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ➤ Sign Up ➤ Sign Up
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OTEZLA
Drugname Dosage Strength RLD Date
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