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REVLIMID Drug Profile

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

This drug has four hundred and thirty-eight patent family members in forty-five countries.

The generic ingredient in REVLIMID is lenalidomide. There are nine 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
Drug Prices: :see details

Pharmacology for Tradename: REVLIMID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXNo6,755,784► subscribe ► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXNo6,555,554► subscribeY ► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXNo6,908,432► 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, 20067,119,106► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 20117,119,106► subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 20136,281,230► 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
8,410,136Methods for treatment of hepatocellular carcinoma using 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione► subscribe
8,722,705Methods for treating diffuse large B-cell lymphoma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► subscribe
8,198,262Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-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
Canada2560523► subscribe
China101863878► subscribe
Poland195916► 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
00717Netherlands► subscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
90004-6Sweden► subscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
C033/2007Ireland► subscribeSPC033/2007: 20080507, EXPIRES: 20220613
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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 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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