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Pomalidomide - Generic Drug Details

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 fifteen 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 forty patent family members in forty-three countries.

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

Summary for pomalidomide

International Patents:	340
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	11
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Clinical Trials:	152
Patent Applications:	442
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

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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	204026-003	Feb 8, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
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	204026-002	Feb 8, 2013	➤ Sign Up	➤ Sign Up
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	➤ Sign Up	➤ Sign Up
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	➤ Sign Up	➤ Sign Up
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
China	102379874	➤ Sign Up
European Patent Office	1667682	➤ Sign Up
China	104606193	➤ Sign Up
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	➤ Sign Up	PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135	00140	Estonia	➤ Sign Up
2105135	CA 2015 00006	Denmark	➤ Sign Up	PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description