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Last Updated: June 24, 2021

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REVLIMID Drug Profile


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When do Revlimid patents expire, and what generic alternatives are available?

Revlimid is a drug marketed by Celgene and is included in one NDA. There are fifteen patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and seventy-five patent family members in forty 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.

DrugPatentWatch® Generic Entry Outlook for Revlimid

Revlimid was eligible for patent challenges on December 27, 2009.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 8, 2028. This may change due to patent challenges or generic licensing.

There have been thirty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (lenalidomide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for REVLIMID
Drug Prices for REVLIMID

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DrugPatentWatch® Estimated 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

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

SponsorPhase
Omar NadeemPhase 2
Roswell Park Cancer InstitutePhase 2
EnteromePhase 1/Phase 2

See all REVLIMID clinical trials

Pharmacology for REVLIMID
Paragraph IV (Patent) Challenges for REVLIMID
Tradename Dosage Ingredient NDA Submissiondate
REVLIMID CAPSULE;ORAL lenalidomide 021880 2016-07-12
REVLIMID CAPSULE;ORAL lenalidomide 021880 2010-08-30
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 021880-003 Jun 29, 2006 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013   Try Before You Buy   Try Before You Buy
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006   Try Before You Buy   Try Before You Buy
>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
0925294 C00925294/01 Switzerland   Try Before You Buy PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
2105135 92642 Luxembourg   Try Before You Buy PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135 300717 Netherlands   Try Before You Buy PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 212 50002-2015 Slovakia   Try Before You Buy PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135 00140 Estonia   Try Before You Buy
2105135 CA 2015 00006 Denmark   Try Before You Buy 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

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Moodys
Baxter
Dow
McKinsey

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