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Last Updated: January 22, 2020

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Lenalidomide - Generic Drug Details

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

Lenalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has five hundred and twelve patent family members in forty-six countries.

There are fourteen drug master file entries for lenalidomide. One supplier is listed for this compound.

Recent Clinical Trials for lenalidomide

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 2
GlaxoSmithKlinePhase 3
University of Michigan Rogel Cancer CenterPhase 2

See all lenalidomide clinical trials

Recent Litigation for lenalidomide

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. AUROBINDO PHARMA LIMITED2020-01-08
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC.2019-12-31
CELGENE CORPORATION v. HETERO LABS LIMITED2019-07-16

See all lenalidomide 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 lenalidomide litigation

Pharmacology for lenalidomide
Synonyms for lenalidomide
(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 (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
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 LENALIDOMIDE
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 lenalidomide

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006   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
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 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 021880-006 Jun 5, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lenalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 00140 Estonia   Start Trial
0925294 56/2007 Austria   Start Trial PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES; REGISTRATION NO/DATE: EU/1/07/391/001 - EU/1/07/391/004 20070614
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
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 07C0056 France   Start Trial PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135 122015000013 Germany   Start Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Moodys
Colorcon
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Harvard Business School

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