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Last Updated: February 17, 2020

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Apremilast - Generic Drug Details

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

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

Apremilast has eighty-eight patent family members in twenty-three countries.

There are twenty-eight drug master file entries for apremilast. One supplier is listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for apremilast

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

SponsorPhase
University Hospital, RouenPhase 3
Medical University of GrazPhase 4
Medical University InnsbruckPhase 4

See all apremilast clinical trials

Recent Litigation for apremilast

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 apremilast litigation

Generic filers with tentative approvals for APREMILAST
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialUNKNOWNUNKNOWN
  Start Trial  Start Trial30MGTABLET, FILM COATED
  Start Trial  Start Trial20MGTABLET, FILM COATED

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
(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 (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
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 APREMILAST
Tradename Dosage Ingredient NDA Submissiondate
OTEZLA TABLET;ORAL apremilast 205437 2018-03-22

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 205437-002 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 Y Y   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 205437-003 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
>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 apremilast

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 apremilast

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
2962690 37/2019 Austria   Start Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
>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:

Express Scripts
Merck
Boehringer Ingelheim
Medtronic
Mallinckrodt
Baxter

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