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Last Updated: April 3, 2020

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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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-one patent family members in forty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Pomalyst

Pomalyst was eligible for patent challenges on February 8, 2017.

There have been thirty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for POMALYST
Drug Prices for POMALYST

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Recent Clinical Trials for POMALYST

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

SponsorPhase
Janssen Research & Development, LLCPhase 2
Andrew Yee, MDPhase 2
RTI InternationalPhase 2

See all POMALYST clinical trials

Recent Litigation for POMALYST

Identify potential future generic entrants

District Court Litigation
Case NameDate
Celgene Corporation v. Hetero Labs Limited2019-08-23
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.2019-07-12
CELGENE CORPORATION v. APOTEX INC.2019-06-19

See all POMALYST litigation

PTAB Litigation
PetitionerDate
Coalition for Affordable Drugs VI LLC2015-05-07
Coalition For Affordable Drugs VI LLC2015-04-23

See all POMALYST litigation

Pharmacology for POMALYST
Synonyms for POMALYST
1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline
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)phthalamide
3-Amino-N-(2,6-dioxo-3-piperidyl)phthalimide
3-Aminophthalimidoglutarimide
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
443919-33-3
4CH-001846
AB0021203
AB01565777_02
AC-26970
ACN-034796
Actimid
Actimid|||CC 4047|||IMiD3
AK104087
AKOS013400288
ANW-69609
AS-17905
AX8235626
BCP02890
BCP0726000263
BCP09107
BDBM65456
CC 4047
CC-4047
CC-4047, Actimid, 19171-19-8
CDC-394
CHEBI:72690
CHEMBL43452
CS-0165
CTK4I8155
D08976
DA-21486
DB08910
DTXSID40893458
EBD24712
FT-0697903
GTPL7348
HMS3655G05
HMS3744K07
HSDB 8222
HY-10984
IMiD 3
IMID-3
IMID-4047
IMiD1
Imnovid
J-012392
J-514302
Lipopolysaccharides from Escherichia coli 055:B5 pound>>Lipopolysaccharides pound>> lipoglycans pound>>endotoxins
LS40023
MLS006011261
NCGC00346551-01
P2074
Phthalimide, 3-amino-N-(2,6-dioxo-3-piperidyl)-
Pomalidomide
Pomalidomide (CC-4047)
Pomalidomide (JAN/USAN/INN)
Pomalidomide [USAN:INN]
Pomalidomide, >=98% (HPLC)
Pomalidomide(CC-4047)
Pomalyst (TN)
PubChem22200
Q7227206
s1567
SB16552
SCHEMBL19250920
SCHEMBL369172
SMR004703012
SR-01000941573
SR-01000941573-1
ST24023268
SW218099-2
SY054807
TC-158354
UVSMNLNDYGZFPF-UHFFFAOYSA-N
V2447
W-5536
ZINC000003940470
Paragraph IV (Patent) Challenges for POMALYST
Tradename Dosage Ingredient NDA Submissiondate
POMALYST CAPSULE;ORAL pomalidomide 204026 2017-02-08

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   Start Trial   Start Trial Y   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 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 204026-004 Feb 8, 2013 RX Yes Yes   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 204026-004 Feb 8, 2013 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 POMALYST

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 204026-001 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 204026-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for POMALYST

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 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
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 CA 2015 00006 Denmark   Start Trial PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
0925294 SPC033/2007 Ireland   Start Trial SPC033/2007: 20080507, EXPIRES: 20220613
0925294 SPC/GB07/047 United Kingdom   Start Trial PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
AstraZeneca
McKesson
Dow
Johnson and Johnson

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