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Last Updated: February 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 six 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 six US patents and five 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

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

Methods for treating multiple myeloma with 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

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷  Try a Trial

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 Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 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 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
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  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 204026-004 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 204026-003 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 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
Japan 2017132817 癌および他の疾患を治療および管理するための免疫調節性化合物を用いた方法および組成物 (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES) ⤷  Try a Trial
South Korea 100822149 ⤷  Try a Trial
Japan 2006528973 ⤷  Try a Trial
Finland 992490 ⤷  Try a Trial
China 1735412 Methods and compositions using selective cytokine inhibitory drugs for treatment and management of cancers and other diseases ⤷  Try a Trial
Japan 2009233326 METHOD FOR DELIVERING DRUG TO PATIENT WHILE AVOIDING OCCURRENCE OF ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY THE DRUG ⤷  Try a Trial
Israel 214644 פורמולציות של 4-אמינו-2-(6,2-דיאוקסופיפרידין-3-איל)איזואינדולין-3,1-דיאון (Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione) ⤷  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
0925294 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; REGISTRATION NO/DATE: EU/1/07/391/001 - EU/1/07/391/004 20070614
2105135 5/2015 Austria ⤷  Try a Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 300717 Netherlands ⤷  Try a Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 00140 Estonia ⤷  Try a Trial
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 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
0925294 07C0056 France ⤷  Try a Trial PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.