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Last Updated: July 6, 2020

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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 twenty patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and ninety-three 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.

US ANDA Litigation and 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.

Indicators of Generic Entry

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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

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

SponsorPhase
Hospital Universitario GetafePhase 4
AstraZenecaPhase 1/Phase 2
GWT-TUD GmbHPhase 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 021880-002 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 021880-001 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   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 021880-006 Jun 5, 2013   Start Trial   Start Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005   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
>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 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
0925294 SPC033/2007 Ireland   Start Trial SPC033/2007: 20080507, EXPIRES: 20220613
0925294 C00925294/01 Switzerland   Start Trial PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
2105135 00140 Estonia   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 verification 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.