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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Queensland Health
Novartis
Dow
Cerilliant
Accenture
Merck
McKesson
Medtronic

Generated: October 24, 2017

DrugPatentWatch Database Preview

Pomalidomide - Generic Drug Details

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What are the generic drug sources for pomalidomide and what is the scope of pomalidomide patent protection?

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 and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pomalidomide has four hundred and fifty-nine patent family members in forty-nine countries and seventeen supplementary protection certificates in twelve countries.

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

Summary for Generic Name: pomalidomide

US Patents:18
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list76
Clinical Trials: see list132
Patent Applications: see list399
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013RXYesYes► Subscribe► 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;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► 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
9,365,538Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,440,194Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
9,101,621Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation► Subscribe
8,648,095Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor► Subscribe
8,822,499Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
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
6,869,399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
9,155,730Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent► Subscribe
8,623,384Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of acute myelogenous leukemia► Subscribe
8,263,637Methods for treatment of multiple myeloma using cyclopropane carboxylic acid {2-[(is)-1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-ox- o-2,3-dihydro-1 h-isoindol-4-yl}-amide► 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
Japan2013091659► Subscribe
European Patent Office2105135► Subscribe
Cyprus1115782► Subscribe
Canada2727824► Subscribe
China1735412► Subscribe
China1668296► Subscribe
Australia2008207659► Subscribe
MexicoPA05004734► Subscribe
China105640918► Subscribe
Japan4307567► 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
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
359Luxembourg► Subscribe91359, EXPIRES: 20220614
642Luxembourg► SubscribePRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
2015000013Germany► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION 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 leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Medtronic
Fuji
US Army
McKinsey
Mallinckrodt
Federal Trade Commission
Deloitte
AstraZeneca

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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