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Last Updated: June 18, 2021

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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty-four patent family members in forty-seven countries.

The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pomalyst

A generic version of POMALYST was approved as pomalidomide by EUGIA PHARMA on October 30th, 2020.

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Drug patent expirations by year for POMALYST
Drug Prices for POMALYST

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical College of WisconsinPhase 2
SanofiPhase 2
OHSU Knight Cancer InstitutePhase 2

See all POMALYST clinical trials

Pharmacology for POMALYST
Paragraph IV (Patent) Challenges for POMALYST
Tradename Dosage Ingredient NDA Submissiondate
POMALYST CAPSULE;ORAL pomalidomide 204026 2017-02-08

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 AB RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 AB RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Try Before You Buy   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013   Try Before You Buy   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013   Try Before You Buy   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013   Try Before You Buy   Try Before You Buy
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for POMALYST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294 C00925294/01 Switzerland   Try Before You Buy PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
0925294 07C0056 France   Try Before You Buy PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
0925294 91359 Luxembourg   Try Before You Buy 91359, EXPIRES: 20220614
2105135 5/2015 Austria   Try Before You Buy PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 300717 Netherlands   Try Before You Buy PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
AstraZeneca
McKesson
Dow
Johnson and Johnson

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