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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 two Paragraph IV challenges.

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

The generic ingredient in REVLIMID is lenalidomide. There are seven 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

Pharmacology for Tradename: REVLIMID

Clinical Trials for: 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<disabled> <disabled>
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXNo6,555,554<disabled>Y <disabled>
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXNo6,908,432<disabled> <disabled>
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Expired Patents for Tradename: REVLIMID

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 20068,288,415<disabled>
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20057,119,106<disabled>
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 20136,555,554<disabled>
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Paragraph IV activity for: REVLIMID

Drugname Dosage Strength RLD Submissiondate
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
8,431,598Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione<disabled in preview>
9,050,324Methods for treating amyloidosis with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione<disabled in preview>
8,440,194Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias<disabled in preview>
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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
Australia2013203194<disabled in preview>
Taiwan200817004<disabled in preview>
Denmark2070920<disabled in preview>
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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
2007 00054Denmark<disabled>
90004-6Sweden<disabled>PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
0150005 00140Estonia<disabled>PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
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