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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 pomalidomide patent protection?

Pomalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are fourteen 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 thirty-nine patent family members in forty-three countries.

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

Summary for pomalidomide

International Patents:	339
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	94
Clinical Trials:	133
Patent Applications:	422
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pomalidomide
DailyMed Link:	pomalidomide at DailyMed

Pharmacology for pomalidomide

Drug Class

Thalidomide Analog

Synonyms for pomalidomide

171P198

19171-19-8

1H-Isoindole-1,3(2H)-dione, 4-amino-2-(2,6-dioxo-3-piperidinyl)-

3-Amino-N-(2,6-dioxo-3-piperidyl)phthalimide

3-Aminophthalimidoglutarimide

4-amino-2- isoindole-1,3-dione

4-amino-2-(2,6-dioxo-3-piperidinyl)-1H-Isoindole-1,3(2H)-dione

4-Amino-2-(2,6-dioxo-3-piperidinyl)isoindole-1,3-dione

4-Amino-2-(2,6-dioxo-3-piperidyl) isoindoline -1,3-dione

4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione

4-AMINO-2-(2,6-DIOXO-PIPERIDIN-3-YL)ISOINDOLE-1,3-DIONE

4-amino-2-(2,6-dioxo(3-piperidyl))isoindoline-1,3-dione

4-amino-2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione

4-amino-2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione

4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione

4-Aminothalidomide

443912-23-0

443919-33-3

4CH-001846

AB0021203

AB01565777_02

AC-26970

AC1L358B

AC1Q6NYN

ACN-034796

Actimid

Actimid (TN)

Actimid|||CC 4047|||IMiD3

AK104087

AKOS013400288

ANW-69609

AS-17905

AX8235626

BC213119

BCP0726000263

BDBM65456

CC 4047

CC-4047

CC-4047, Actimid, 19171-19-8

CDC-394

CHEBI:72690

CHEMBL43452

CS-0165

CTK4I8155

D08976

D0A3ZU

DB08910

EBD24712

FT-0697903

GTPL7348

HE056568

HE246008

HE321828

HMS3655G05

HSDB 8222

HY-10984

IMiD 3

IMID-3

IMID-4047

IMiD1

Imnovid

J-012392

J-514302

KB-239921

KB-239922

KB-71997

LS40023

MFCD12756407

MLS006011261

MolPort-016-633-239

NCGC00346551-01

P2074

Phthalimide, 3-amino-N-(2,6-dioxo-3-piperidyl)-

Pomalidomide (CC-4047)

Pomalidomide (Immunomodulator)

Pomalidomide (JAN/USAN/INN)

Pomalidomide [USAN:INN]

Pomalidomide, >=98% (HPLC)

Pomalyst

Pomalyst (TN)

PubChem22200

RL02421

s1567

SCHEMBL19250920

SCHEMBL369172

SMR004703012

SR-01000941573

SR-01000941573-1

ST24023268

TC-158354

UVSMNLNDYGZFPF-UHFFFAOYSA-N

V2447

W-5536

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

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Expired US Patents for pomalidomide

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

Non-Orange Book US Patents for pomalidomide

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
6,869,399	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
7,141,018	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
7,959,566	Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
6,767,326	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug

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International Patents for pomalidomide

Country	Document Number	Estimated Expiration
Australia	2012200259
European Patent Office	2425836
China	103393695
Russian Federation	2348407

Supplementary Protection Certificates for pomalidomide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015000013	Germany		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
00717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0150005 00140	Estonia		PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013