Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School

Last Updated: December 5, 2019

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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and sixty-three 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.

Drug patent expirations by year for POMALYST
Drug Prices for POMALYST

See drug prices 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.

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
443912-23-0
443919-33-3
4CH-001846
AB0021203
AB01565777_02
AC-26970
AC1L358B
AC1Q6NYN
ACN-034796
Actimid
Actimid|||CC 4047|||IMiD3
AK104087
AKOS013400288
ANW-69609
AS-17905
AX8235626
BC213119
BCP02890
BCP0726000263
BCP09107
BDBM65456
CC 4047
CC-4047
CC-4047, Actimid, 19171-19-8
CDC-394
CHEBI:72690
CHEMBL43452
CS-0165
CTK4I8155
D08976
DB08910
EBD24712
FT-0697903
GTPL7348
HMS3655G05
HSDB 8222
HY-10984
IMiD 3
IMID-3
IMID-4047
IMiD1
Imnovid
J-012392
J-514302
KB-239921
KB-239922
KB-71997
Lipopolysaccharides from Escherichia coli 055:B5 pound>>Lipopolysaccharides pound>> lipoglycans pound>>endotoxins
LS40023
MFCD12756407 (97%)
MLS006011261
MolPort-016-633-239
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)
Pomalyst (TN)
PubChem22200
RL02421
s1567
SB16552
SCHEMBL19250920
SCHEMBL369172
SMR004703012
SR-01000941573
SR-01000941573-1
ST24023268
SW218099-2
SY054807
TC-158354
UVSMNLNDYGZFPF-UHFFFAOYSA-N
V2447
W-5536
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   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
>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 204026-003 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 204026-002 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 5/2015 Austria   Start Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Dow
AstraZeneca
Mallinckrodt
Johnson and Johnson

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