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Serving leading biopharmaceutical companies globally:

Teva
Cerilliant
UBS
Accenture
Dow
Cipla
Healthtrust
Colorcon
Argus Health
Novartis

Generated: November 18, 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 fifty-nine patent family members in forty-nine countries and seventeen supplementary protection certificates in twelve 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.
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► SubscribeY ► 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;ORAL204026-002Feb 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;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 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;ORAL204026-004Feb 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;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 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
7,119,106Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline► Subscribe
8,143,286Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione)► 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
9,353,080Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
7,468,363Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione► 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
9,365,538Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
7,323,479Methods for treatment and management of brain cancer using 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-methylisoindoline► 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
7,855,217Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► 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
China102335173► Subscribe
South Korea100534498► Subscribe
Poland191566► Subscribe
Spain2359778► Subscribe
Cyprus1115782► Subscribe
Hong Kong1072180► Subscribe
China1239959► Subscribe
Hong Kong1132502► Subscribe
Canada2741575► Subscribe
China1735412► 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
2015Austria► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2007 00054Denmark► Subscribe
56/2007Austria► SubscribePRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
C0056France► SubscribePRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
140Estonia► Subscribe
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
0717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
McKinsey
UBS
Baxter
Johnson and Johnson
Moodys
Queensland Health
McKesson
US Army

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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