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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Boehringer Ingelheim
US Department of Justice
Fuji
Healthtrust
McKinsey
Cerilliant
Chubb
McKesson

Generated: July 22, 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 seventy-six patent family members in forty-six countries.

The generic ingredient in REVLIMID is lenalidomide. There are eleven 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

Patents:27
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list418
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;ORAL021880-004Jun 29, 2006RXYesYes6,561,977► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo8,315,886► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo8,648,095► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes8,741,929► Subscribe ► 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;ORAL021880-003Jun 29, 20066,281,230► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 20138,288,415► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 20058,288,415► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 20116,281,230► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 20117,119,106► Subscribe
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Paragraph IV activity 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
7,393,863Methods of using N-{[2-(2,6-dioxo(3-piperidyl)-1,3-dioxoisoindolin-4-yl]methyl}cyclopropyl- -carboxamide for the treatment and management of myelodysplastic syndromes► Subscribe
7,874,984Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug► Subscribe
9,662,321Methods for treating newly diagnosed multiple myeloma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
6,476,052 Isoindolines, method of use, and pharmaceutical compositions► Subscribe
8,747,814Oral care compositions and methods► 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
European Patent Office2226740► Subscribe
China100579527► Subscribe
Norway20061455► Subscribe
European Patent Office2915533► Subscribe
Hong Kong1073427► 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
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
C0056France► SubscribePRODUCT NAME: IENALIDOMIDE EVENTUELLEMENT SOUS LA FORME D?UN DE SES SELS D?ADDITION D?ACIDES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/391/001 DU 20070614; REGISTRATION NO/DATE AT EEC: EU/1/07/391/001-004 DU 20070614
2007 00054Denmark► Subscribe
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. 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 500+ biopharmaceutical companies globally:

Cerilliant
Dow
UBS
Julphar
Medtronic
Novartis
Federal Trade Commission
Merck
Cipla
Queensland Health

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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