Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 17, 2019

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-one patents protecting this drug and three Paragraph IV challenges.

This drug has five hundred and six 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
Drug Prices for REVLIMID

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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.

Recent Clinical Trials for REVLIMID

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SponsorPhase
Alliance Foundation Trials, LLC.Phase 2
AmgenPhase 4
AdaptivePhase 3

See all REVLIMID clinical trials

Recent Litigation for REVLIMID

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. HETERO LABS LIMITED2019-07-16
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.2019-07-12
CELGENE CORPORATION v. CIPLA LIMITED2019-07-03

See all REVLIMID litigation

PTAB Litigation
PetitionerDate
Alvogen Pine Brook LLC2018-09-12
Dr. Reddy's Laboratories, Inc2018-08-03
Dr. Reddy's Laboratories, Inc.2018-08-03

See all REVLIMID litigation

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
Paragraph IV (Patent) Challenges for REVLIMID
Tradename Dosage Ingredient NDA Submissiondate
REVLIMID CAPSULE;ORAL lenalidomide 021880 2016-07-12
REVLIMID CAPSULE;ORAL lenalidomide 021880 2010-07-12

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   Start Trial   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No   Start Trial   Start Trial Y   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 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 REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for REVLIMID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 C300717 Netherlands   Start Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 SPC/GB07/047 United Kingdom   Start Trial PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0925294 91359 Luxembourg   Start Trial 91359, EXPIRES: 20220614
2105135 CA 2015 00006 Denmark   Start Trial PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2105135 5/2015 Austria   Start Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 300717 Netherlands   Start Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 C20150005 00140 Estonia   Start Trial PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.