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POMALYST Drug Profile

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Which patents cover Pomalyst, and what substitute generic drugs are available?

Pomalyst is a drug marketed by Celgene and is included in one NDA. There are eighteen patents protecting this drug.

This drug has four hundred and nine patent family members in forty-seven countries.

The generic ingredient in POMALYST is pomalidomide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.

Summary for Tradename: POMALYST

Patents:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list75
Clinical Trials: see list31
Patent Applications: see list236
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:POMALYST at DailyMed

Pharmacology for Tradename: POMALYST

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes6,755,784► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo8,198,262► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo6,561,976► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo8,158,653► SubscribeY ► Subscribe
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Expired Patents for Tradename: POMALYST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 20138,158,653► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 20135,635,517► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 20135,635,517► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 20138,158,653► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 20136,476,052► Subscribe
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Non-Orange Book Patents for Tradename: POMALYST

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
9,393,238Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent► Subscribe
7,354,948Methods for treatment of chronic uveitis using cyclopropyl-n-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)eth- yl]-3-oxoisoindoline-4-yl}carboxamide► Subscribe
7,959,566Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
9,353,080Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► 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
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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: POMALYST

Country Document Number Estimated Expiration
Israel150307► Subscribe
Japan2015131863► Subscribe
South Korea20090048520► Subscribe
European Patent Office2305663► Subscribe
Portugal2426118► 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: POMALYST

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
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
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
359Luxembourg► Subscribe91359, EXPIRES: 20220614
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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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