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Last Updated: March 29, 2024

pomalyst Drug Patent Profile


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When do Pomalyst patents expire, and what generic alternatives are available?

Pomalyst is a drug marketed by Bristol and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty-six patent family members in forty-eight 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.

DrugPatentWatch® Generic Entry Outlook for Pomalyst

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

There have been twenty-eight 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.

There is one tentative approval for the generic drug (pomalidomide), which indicates the potential for near-term generic launch.

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
University of ChicagoPhase 2
Regeneron PharmaceuticalsPhase 3
Bristol-Myers SquibbPhase 3

See all pomalyst clinical trials

Pharmacology for pomalyst
Drug ClassThalidomide Analog
Paragraph IV (Patent) Challenges for POMALYST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
POMALYST Capsules pomalidomide 1 mg, 2 mg, 3 mg and 4 mg 204026 6 2017-02-08

US Patents and Regulatory Information for pomalyst

pomalyst is protected by four US patents and four FDA Regulatory Exclusivities.

Patents protecting pomalyst

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting pomalyst

FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for pomalyst

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Imnovid (previously Pomalidomide Celgene) pomalidomide EMEA/H/C/002682
Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Authorised no no no 2013-08-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for pomalyst

See the table below for patents covering pomalyst around the world.

Country Patent Number Title Estimated Expiration
Denmark 2391355 ⤷  Try a Trial
European Patent Office 2425836 Formes polymorphes de 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-pipéridine-2,6-dione (Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione) ⤷  Try a Trial
South Korea 20120014114 FORMULATIONS OF 4-AMINO-2-(2,6-DIOXOPIPERIDINE-3-YL)ISOINDOLINE-1,3-DIONE ⤷  Try a Trial
European Patent Office 3199149 PRÉPARATIONS DE 4-AMINO-2-(2,6-DIOXOPIPÉRIDINE-3-YL)ISOINDOLINE-1,3-DIONE (FORMULATIONS OF 4-AMINO-2-(2,6-DIOXOPIPERIDINE-3-YL)ISOINDOLINE-1,3-DIONE) ⤷  Try a Trial
Croatia P20110836 ⤷  Try a Trial
Israel 174067 צורות פולימורפיות של 3-(4-אמינו-1-אוקסו-1, 3 דיהידרו-איסואינדול-2-יל)-פיפרידין-6,2-דיון (Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione) ⤷  Try a Trial
Israel 178747 3-(4-אמינו-1-אוקסו- 1, 3-דיהידרו-איזואינדול-2-יל)-פיפרידין-6,2-דיון או מלח פארמצבטי מקובל, סולבט או סטראואיזומר שלו לשימוש בטיפול בלימפומה נון הודג'קינס, אופציונאלי גם בשילוב עם גורמים תרפואטיים נוספים (3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt, solvate or stereoisomer thereof, for use in treating non-hodgkin's lymphoma, optionally in combination with additional therapeutic agent(s)) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pomalyst

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 122015000013 Germany ⤷  Try a Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 92642 Luxembourg ⤷  Try a Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2105135 C300717 Netherlands ⤷  Try a Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 91359 Luxembourg ⤷  Try a Trial 91359, EXPIRES: 20220614
2105135 00140 Estonia ⤷  Try a Trial
2105135 1590004-6 Sweden ⤷  Try a Trial PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
0925294 SZ 56/2007 Austria ⤷  Try a Trial PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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