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Serving leading biopharmaceutical companies globally:

UBS
Cipla
Fuji
US Department of Justice
Cerilliant
Queensland Health
Chinese Patent Office
Johnson and Johnson
Accenture
Daiichi Sankyo

Generated: January 16, 2018

DrugPatentWatch Database Preview

REVLIMID Drug Profile

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When do Revlimid patents expire, and when can generic versions of Revlimid launch?

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

This drug has four hundred and ninety-one patent family members in forty-five countries and seventeen supplementary protection certificates in twelve countries.

The generic ingredient in REVLIMID is lenalidomide. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for REVLIMID
Drug patent expirations by year for REVLIMID
Pharmacology for REVLIMID

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 021880-004 Jun 29, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ➤ Subscribe ➤ Subscribe
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for REVLIMID
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 2.5 mg and 20 mg ➤ Subscribe 7/12/2016
➤ Subscribe Capsules 5 mg, 10 mg and 15 mg ➤ Subscribe 8/30/2010
➤ Subscribe Capsules 25 mg ➤ Subscribe 7/12/2010

Non-Orange Book US Patents for REVLIMID

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,207,200 Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroindol-2-yl)-piperidine-2,6-dione follow by autologous stem cell transplantation ➤ Subscribe
9,056,103 Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias ➤ Subscribe
8,492,406 Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione ➤ Subscribe
8,431,598 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ➤ Subscribe
6,476,052 Isoindolines, method of use, and pharmaceutical compositions ➤ Subscribe
8,632,787 Methods using immunomodulatory compounds for treatment of certain leukemias ➤ Subscribe
6,767,326 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug ➤ Subscribe
5,798,368 Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines and method of reducing TNF.alpha. levels ➤ Subscribe
9,050,324 Methods for treating amyloidosis with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione ➤ Subscribe
9,283,215 Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with antibodies ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for REVLIMID

Supplementary Protection Certificates for REVLIMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294/01 Switzerland ➤ Subscribe PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
0717 Netherlands ➤ Subscribe PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
00717 Netherlands ➤ Subscribe PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
C0056 France ➤ Subscribe PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
642 Luxembourg ➤ Subscribe PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
C/GB07/047 United Kingdom ➤ Subscribe 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
2015 Austria ➤ Subscribe PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2007 00054 Denmark ➤ Subscribe
56/2007 Austria ➤ Subscribe 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
2 50002-2015 Slovakia ➤ Subscribe PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Express Scripts
US Department of Justice
Fish and Richardson
Chinese Patent Office
Chubb
Federal Trade Commission
UBS

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