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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Medtronic
Cerilliant
Harvard Business School
Novartis
Healthtrust
US Department of Justice
Citi
Mallinckrodt
McKesson

Generated: October 23, 2017

DrugPatentWatch Database Preview

REVLIMID Drug Profile

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What is the patent landscape for Revlimid, 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-four 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 Tradename: REVLIMID

US Patents:27
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list428
Patent Applications: see list354
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:REVLIMID at DailyMed

Pharmacology for Tradename: 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;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for REVLIMID

Drugname Dosage Strength RLD Submissiondate
lenalidomide Capsules 2.5 mg and 20 mg Revlimid  7/12/2016
lenalidomideCapsules5 mg, 10 mg and 15 mgRevlimid8/30/2010
lenalidomideCapsules25 mgRevlimid7/12/2010

Non-Orange Book Patents for Tradename: 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
9,283,215Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with antibodies► Subscribe
8,207,200Methods 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
8,759,375Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with proteasome inhibitor► Subscribe
8,492,406Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,722,647Methods for treating amyloidosis using 4-(amino)-2-(2,6-Dioxo(3-piperidyl))- isoindoline-1,3-dione► Subscribe
9,365,538Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
5,798,368 Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines and method of reducing TNF.alpha. levels► Subscribe
9,498,472Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
9,050,324Methods for treating amyloidosis with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,431,598Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: REVLIMID

Country Document Number Estimated Expiration
China1697655► Subscribe
Australia2003290651► Subscribe
Japan2006528973► Subscribe
Taiwan200730175► Subscribe
MexicoPA05012155► Subscribe
China1239959► Subscribe
Turkey200000107► Subscribe
Mexico346372► Subscribe
China102335173► Subscribe
BrazilPI0616670► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: REVLIMID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
C0056France► SubscribePRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
642Luxembourg► SubscribePRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
140Estonia► Subscribe
2015Austria► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
C/GB07/047United Kingdom► SubscribePRODUCT 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
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
2015000013Germany► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
McKinsey
Queensland Health
Express Scripts
AstraZeneca
UBS
US Army
Citi
Medtronic

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 verifification 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.

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