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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Healthtrust
Cantor Fitzgerald
Mallinckrodt
Harvard Business School
Baxter
Deloitte
Fish and Richardson
Colorcon

Generated: May 25, 2018

DrugPatentWatch Database Preview

Apremilast - Generic Drug Details

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What are the generic sources for apremilast and what is the scope of apremilast patent protection?

Apremilast
is the generic ingredient in one branded drug marketed by Celgene Corp and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apremilast has one hundred and two patent family members in twenty-two countries.

There are twenty-six drug master file entries for apremilast. One supplier is listed for this compound.
Summary for apremilast
Pharmacology for apremilast
Synonyms for apremilast
(+)-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 (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
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 apremilast

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 205437-001 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 205437-001 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
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
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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Non-Orange Book US Patents for apremilast

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,283,207 Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione ➤ Try a Free Trial
7,507,759 Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione ➤ Try a Free Trial
7,276,529 Methods of the treatment or prevention of exercise-induced asthma using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione ➤ Try a Free Trial
8,629,173 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Healthtrust
Boehringer Ingelheim
Julphar
McKinsey
US Army
Deloitte
Cipla
Merck

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.