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Last Updated: January 23, 2021

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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 two branded drugs marketed by Breckenridge, Eugia Pharma, and Celgene, and is included in three NDAs. 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.

Summary for pomalidomide

International Patents:	372
US Patents:	11
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	11
Suppliers / Packagers:	1
Bulk Api Vendors:	122
Clinical Trials:	183
Patent Applications:	2,902
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pomalidomide
DailyMed Link:	pomalidomide at DailyMed

Recent Clinical Trials for pomalidomide

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

Sponsor	Phase
Cancer Trials Ireland	Phase 1
Janssen Pharmaceuticals	Phase 1
Sanofi	Phase 1/Phase 2

See all pomalidomide clinical trials

Pharmacology for pomalidomide

Drug Class	Thalidomide Analog

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

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Glossary

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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	204026-002	Feb 8, 2013	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	Start Trial	Start Trial			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

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

International Patents for pomalidomide

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Country	Patent Number	Estimated Expiration
European Patent Office	2316455	Start Trial
South Korea	20050072801	Start Trial
Japan	2006514689	Start Trial
South Korea	20140082857	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for pomalidomide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300717	Netherlands	Start Trial	PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	212 50002-2015	Slovakia	Start Trial	PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	122015000013	Germany	Start Trial	PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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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