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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Chubb
Express Scripts
Mallinckrodt
US Army
QuintilesIMS
Colorcon
Deloitte
Boehringer Ingelheim

Generated: August 15, 2018

DrugPatentWatch Database Preview

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 fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty-nine patent family members in forty-three countries.

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

Drug patent expirations by year for POMALYST
Generic Entry Opportunity Date for POMALYST
Generic Entry Date for POMALYST*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY.
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for POMALYST
Synonyms for POMALYST
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
Pomalidomide (CC-4047)
Pomalidomide (Immunomodulator)
Pomalidomide (JAN/USAN/INN)
Pomalidomide [USAN:INN]
Pomalidomide, >=98% (HPLC)
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 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 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for POMALYST

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

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Paragraph IV (Patent) Challenges for POMALYST
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for POMALYST

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
9,365,538 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ➤ Try a Free Trial
8,188,118 Method for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with antibodies ➤ Try a Free Trial
8,431,598 Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione ➤ Try a Free Trial
9,155,730 Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent ➤ Try a Free Trial
8,492,406 Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione ➤ Try a Free Trial
7,977,357 Polymorphic forms of 3-(4-amino-1-oxo-1, 3 dihydro-isoindo1-2-yl)-piperidine-2,6-dione ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for POMALYST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150005 00140 Estonia ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
00717 Netherlands ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015 Austria ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015 00006 Denmark ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2015000013 Germany ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2 50002-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Moodys
Medtronic
Deloitte
Cerilliant
Citi
Fish and Richardson
Daiichi Sankyo

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