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Generated: June 19, 2019

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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 eighteen patents protecting this drug and three Paragraph IV challenges.

This drug has five hundred and two 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-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-isoindolinyl)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
AB0017965
AB01273975_03
AB01273975-01
AB01273975-02
ABP001089
AC-914
AC1L50II
ACN-034469
AK-47482
AKOS005146276
AKOS005174869
ALBB-015321
AM20050439
AN-1103
API0003142
AX8136128
BC220870
BCP01390
BCP9000847
BCPP000186
BDBM65454
BR-47482
CAS-191732-72-6
CC 5013
CC 5013; Revimid
CC-5013
CDC 501
CDC-501
CDC-5013
CHEBI:63791
CHEMBL848
CS-0125
CTK8E1915
D04687
DB00480
DSSTox_CID_26664
DSSTox_GSID_46664
DSSTox_RID_81806
DTXSID8046664
ENMD 0997
ENMD-0997
FT-0659651
FT-0670758
GOTYRUGSSMKFNF-UHFFFAOYSA-N
GTPL7331
HMS3654G07
HSDB 8220
HY-A0003
I06-0831
IMid-1
IMID-5013
IMiD3
KB-53181
KS-00000GHH
KS-1207
Lenalidomide
Lenalidomide (CC-5013)
Lenalidomide (USAN/INN)
Lenalidomide [USAN:INN:BAN]
Lenalidomide [USAN]
LS-184040
MCULE-9771679074
MFCD07772307 (97%)
MLS003899194
MolPort-003-848-370
NCGC00167491-01
NCGC00167491-02
NCGC00167491-03
NCGC00167491-04
NSC-747972
NSC747972
PubChem19113
Q-101410
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
SW218084-2
SY047646
T5245
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 021880-003 Jun 29, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 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 REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ 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 REVLIMID
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 2.5 mg and 20 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 5 mg, 10 mg and 15 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 25 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for REVLIMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 00140 Estonia ➤ Sign Up
2105135 300717 Netherlands ➤ Sign Up PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 122015000013 Germany ➤ Sign Up PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 SPC033/2007 Ireland ➤ Sign Up SPC033/2007: 20080507, EXPIRES: 20220613
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Colorcon
Healthtrust
Mallinckrodt
Citi

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