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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

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 patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has three hundred and ninety-three patent family members in forty 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
EMN Research ItalyPhase 3
National Cancer Institute, FrancePhase 1/Phase 2
Institut CuriePhase 1/Phase 2

See all lenalidomide clinical trials

Pharmacology for lenalidomide
Paragraph IV (Patent) Challenges for LENALIDOMIDE
Tradename Dosage Ingredient NDA Submissiondate
REVLIMID CAPSULE;ORAL lenalidomide 021880 2016-07-12
REVLIMID CAPSULE;ORAL lenalidomide 021880 2010-08-30
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 021880-005 Dec 21, 2011 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 021880-005 Dec 21, 2011 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 021880-002 Dec 27, 2005 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 021880-001 Dec 27, 2005   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011   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 021880-004 Jun 29, 2006   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 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 00140 Estonia   Start Trial
2105135 92642 Luxembourg   Start Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
0925294 07C0056 France   Start Trial PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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