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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Moodys
Boehringer Ingelheim
Federal Trade Commission
Farmers Insurance
Baxter
McKinsey
Johnson and Johnson
Harvard Business School

Generated: August 19, 2018

DrugPatentWatch Database Preview

REVLIMID Drug Profile

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

Revlimid is a drug marketed by Celgene and is included in one NDA. There are twenty-three patents protecting this drug and three Paragraph IV challenges.

This drug has four hundred and eighty-nine patent family members in forty-six countries.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.

Drug patent expirations by year for REVLIMID
Generic Entry Opportunity Date for REVLIMID
Generic Entry Date for REVLIMID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 REVLIMID
Synonyms for REVLIMID
(3S)-3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline
191732-72-6
2, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-, (3S)-
3-?(4-?AMINO-?1,?3-?DIHYDRO-?1-?OXO-?2H-?ISOINDOL-?2-?YL)-?2,?6-?PIPERIDINEDIONE
3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-dioxopiperidine
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-piperidinedione
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
3-(4-amino-1-oxo-2,3-dihydro-1H-isoindol-2-yl)piperidine-2,6-dione
3-(4-amino-1-oxo-isoindolin-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione
3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-2,6-piperidinedione
3-(7-Amino-3-oxo-1H-isoindol-2-yl)-piperidine-2,6-dione
3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione
346670-73-3
4-amino-2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1H-isoindol-1-one
443912-14-9
732L726
879126-98-4
AB0017965
AB01273975_03
AB01273975-01
AB01273975-02
ABP001089
AC-914
AC1L50II
AK-47482
AKOS005146276
AKOS005174869
ALBB-015321
AM20050439
AN-1103
API0003142
AX8136128
BC220870
BCP9000847
BCPP000186
BDBM65454
Bio-0168
BR-47482
CAS-191732-72-6
CC 5013
CC-5013
CC-5013, Revlimid, Lenalidomide
CC5013
CDC 501
CDC-501
CDC-5013
Celgene brand of lenalidomide
CHEBI:63791
CHEMBL848
CS-0125
CTK8E1915
D04687
D0Q5NX
DB00480
DSSTox_CID_26664
DSSTox_GSID_46664
DSSTox_RID_81806
DTXSID8046664
ENMD 0997
ENMD-0997
FT-0659651
FT-0670758
GOTYRUGSSMKFNF-UHFFFAOYSA-N
GTPL7331
HE054620
HE247796
HE302018
HE337084
HE343617
HMS3654G07
HY-A0003
I06-0831
IMid-1
IMID-5013
IMiD3
IMiD3cpd
KB-53181
KS-00000GHH
KS-1207
Lenalidomide
Lenalidomide (CC-5013)
Lenalidomide (Immunomodulator)
Lenalidomide (USAN/INN)
Lenalidomide [USAN:INN:BAN]
Lenalidomide [USAN]
Lenalidomide hydrate
LS-184040
MCULE-9771679074
MFCD07772307
MLS003899194
MolPort-003-848-370
NCGC00167491-01
NCGC00167491-02
NCGC00167491-03
NCGC00167491-04
NSC-747972
NSC747972
PubChem19113
Q-101410
Revamid
Revimid
Revlimid (Celgene)
Revlimid (lenalidomide)
Revlimid (TN)
Revlimid (TN) (Celgene)
Revlimid, Lenalidomide, CC-5013
RTR-008901
S-4172
s1029
SCHEMBL1980410
SCHEMBL32978
SMR002529986
SR-01000883999
SR-01000883999-1
STK639603
Thalidomide analog CC-5013
Tox21_112492
Tox21_112492_1
TR-008901
Z1741976709
ZX-AN014029

US Patents and Regulatory Information for REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Expired US Patents for REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for REVLIMID
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 2.5 mg and 20 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Capsules 5 mg, 10 mg and 15 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Capsules 25 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for REVLIMID

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
8,632,787 Methods using immunomodulatory compounds for treatment of certain leukemias ➤ Try a Free Trial
6,476,052 Isoindolines, method of use, and pharmaceutical compositions ➤ Try a Free Trial
8,404,716 Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine ➤ Try a Free Trial
8,440,194 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for REVLIMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
642 Luxembourg ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2 50002-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
90004-6 Sweden ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2007 00054 Denmark ➤ Try a Free Trial PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chinese Patent Office
Moodys
Harvard Business School
Daiichi Sankyo
US Department of Justice
Deloitte
US Army
Colorcon

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