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Last Updated: October 16, 2021

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LENALIDOMIDE - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of freedom to operate?

Lenalidomide is the generic ingredient in two branded drugs marketed by Arrow Intl and Celgene, and is included in two NDAs. There are fifteen 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 seventy-six patent family members in forty countries.

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

Recent Clinical Trials for LENALIDOMIDE

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

SponsorPhase
Juan DuPhase 2
Marcelo Pasquini, MDPhase 2
ADC Therapeutics S.A.Phase 1

See all LENALIDOMIDE clinical trials

Generic filers with tentative approvals for LENALIDOMIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial25MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial15MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 021880-004 Jun 29, 2006 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 021880-006 Jun 5, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ⤷  Free Forever Trial ⤷  Free Forever 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 C300717 Netherlands ⤷  Free Forever Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 07C0056 France ⤷  Free Forever Trial PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135 CA 2015 00006 Denmark ⤷  Free Forever Trial PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Moodys
Express Scripts
Merck
Harvard Business School

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