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Mallinckrodt
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McKinsey
Harvard Business School

Last Updated: December 9, 2019

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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 patent protection?

Pomalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are ten 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 seventy patent family members in forty-six countries.

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

Recent Clinical Trials for pomalidomide

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

SponsorPhase
RTI InternationalPhase 2
Bristol-Myers SquibbPhase 1/Phase 2
The Cleveland ClinicPhase 2

See all pomalidomide clinical trials

Recent Litigation for pomalidomide

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 pomalidomide litigation

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

See all pomalidomide litigation

Pharmacology for pomalidomide
Synonyms for pomalidomide
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 (CC-4047)
Pomalidomide (JAN/USAN/INN)
Pomalidomide [USAN:INN]
Pomalidomide, >=98% (HPLC)
Pomalyst
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 POMALIDOMIDE
Tradename Dosage Ingredient NDA Submissiondate
POMALYST CAPSULE;ORAL pomalidomide 204026 2017-02-08

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   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 204026-003 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 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 204026-001 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 pomalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 00140 Estonia   Start Trial
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 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

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

Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Express Scripts
Colorcon
Merck
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.