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Last Updated: July 2, 2020

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 freedom to operate?

Pomalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pomalidomide has three hundred and seventy-two patent family members in forty-seven countries.

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

Recent Clinical Trials for POMALIDOMIDE

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SponsorPhase
Medical College of WisconsinPhase 1
VU University Medical CenterPhase 2
TakedaPhase 1

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

US Patents and Regulatory Information for 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;ORAL 204026-001 Feb 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>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 POMALIDOMIDE

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

Supplementary Protection Certificates for POMALIDOMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 C20150005 00140 Estonia   Start Trial PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
2105135 5/2015 Austria   Start Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 92642 Luxembourg   Start Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135 00140 Estonia   Start Trial
2105135 C300717 Netherlands   Start Trial 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:

Mallinckrodt
McKesson
Moodys
Johnson and Johnson
AstraZeneca
McKinsey

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