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Serving 500+ biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Accenture
Deloitte
McKesson
Novartis
Chubb
Boehringer Ingelheim
Cipla
US Department of Justice

Generated: September 25, 2017

DrugPatentWatch Database Preview

POMALYST Drug Profile

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What is the patent landscape for Pomalyst, and what generic Pomalyst alternatives are available?

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

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

The generic ingredient in POMALYST is pomalidomide. There are nine 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 list38
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013RXYesNo► Subscribe► Subscribe ► 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;ORAL204026-004Feb 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;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for POMALYST

Drugname Dosage Strength RLD Submissiondate
pomalidomideCapsules1 mg, 2 mg, 3 mg and 4 mgPomalyst2/8/2017

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
7,393,862Method using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► 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
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
9,283,215Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione in combination with antibodies► Subscribe
9,498,472Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
9,101,622Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone► 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
8,722,647Methods for treating amyloidosis using 4-(amino)-2-(2,6-Dioxo(3-piperidyl))- isoindoline-1,3-dione► Subscribe
8,058,443Processes for preparing polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-YL))-piperidine-2,6-dione► Subscribe
8,198,306Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a 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
South Korea100979869► Subscribe
Canada2525557► Subscribe
New Zealand501429► Subscribe
European Patent Office2177517► Subscribe
Serbia20120340► Subscribe
Hong Kong1021819► Subscribe
Monaco225► Subscribe
Spain2372577► Subscribe
South Korea100793564► Subscribe
European Patent Office2226740► 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
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
2015000013Germany► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
140Estonia► Subscribe
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2015Austria► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2007 00054Denmark► Subscribe
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. 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 500+ biopharmaceutical companies globally:

Covington
AstraZeneca
Fish and Richardson
Cerilliant
Baxter
US Department of Justice
Johnson and Johnson
Chubb
Federal Trade Commission
Novartis

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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