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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
McKesson
Daiichi Sankyo
Fuji
Chubb
Cipla
US Department of Justice
Accenture
McKinsey

Generated: January 21, 2018

DrugPatentWatch Database Preview

POMALYST Drug Profile

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When do Pomalyst patents expire, and what generic 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 sixty patent family members in forty-nine countries.

The generic ingredient in POMALYST is pomalidomide. There are ten 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 POMALYST
Drug patent expirations by year for POMALYST
Pharmacology for POMALYST

US Patents and Regulatory Information for 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;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for POMALYST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for POMALYST
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe 2/8/2017

Non-Orange Book US Patents for 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
8,143,286 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione) ➤ Subscribe
8,722,705 Methods for treating diffuse large B-cell lymphoma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents ➤ Subscribe
8,263,637 Methods 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
8,198,306 Methods 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
6,555,554 Isoindolines, method of use, and pharmaceutical compositions ➤ Subscribe
8,431,598 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ➤ Subscribe
8,288,415 Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione ➤ Subscribe
5,798,368 Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines and method of reducing TNF.alpha. levels ➤ Subscribe
8,722,647 Methods for treating amyloidosis using 4-(amino)-2-(2,6-Dioxo(3-piperidyl))- isoindoline-1,3-dione ➤ Subscribe
8,822,499 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for POMALYST

Supplementary Protection Certificates for POMALYST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150005 00140 Estonia ➤ Subscribe PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
00717 Netherlands ➤ Subscribe PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
359 Luxembourg ➤ Subscribe 91359, EXPIRES: 20220614
2015 Austria ➤ Subscribe PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015000013 Germany ➤ Subscribe PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294/01 Switzerland ➤ Subscribe PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
C033/2007 Ireland ➤ Subscribe SPC033/2007: 20080507, EXPIRES: 20220613
2015 00006 Denmark ➤ Subscribe PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2007 00054 Denmark ➤ Subscribe
0717 Netherlands ➤ Subscribe PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Cipla
Covington
Accenture
Cantor Fitzgerald
Dow
Baxter
Mallinckrodt
Fuji
Moodys

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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