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Pomalidomide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pomalidomide?

Pomalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are seven drug master file entries for pomalidomide. One supplier is listed for this compound.

Summary for Generic Name: pomalidomide

Tradenames:1
Patents:19
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list1
Bulk Api Vendors: see list76
Clinical Trials: see list83
Patent Applications: see list223
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pomalidomide at DailyMed

Pharmacology for Ingredient: pomalidomide

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;ORAL204026-001Feb 8, 2013RXYesNo► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo8,735,428► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes8,735,428► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pomalidomide

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

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
7,141,018Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
6,281,230 Isoindolines, method of use, and pharmaceutical compositions► Subscribe
8,530,498Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione► 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
7,041,680(R) and (S) isomers of substituted 2-(2,6-dioxopiperidin-3-yl) phthalimides and 1-oxoisoindolines and methods of using the same► 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 Ingredient: pomalidomide

Country Document Number Estimated Expiration
South Korea20080058469► Subscribe
World Intellectual Property Organization (WIPO)2007041637► Subscribe
Japan2015131863► Subscribe
Japan2012526855► Subscribe
Australia2004270211► 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: POMALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
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
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
359Luxembourg► Subscribe91359, EXPIRES: 20220614
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
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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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