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Last Updated: September 26, 2022

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 Celgene 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.

Drug patent expirations by year for POMALYST
Drug Prices for POMALYST

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

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

SponsorPhase
Bristol-Myers SquibbPhase 3
Genentech, Inc.Phase 1/Phase 2
Rajshekhar Chakraborty, MDPhase 1/Phase 2

See all POMALYST clinical trials

Pharmacology for POMALYST
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting POMALYST

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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 yes 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 3042659 See Plans and Pricing
Japan 2009138009 SUBSTITUTED 2-(2,6-DIOXOPIPERIDIN-3-YL)-PHTHALIMIDES, 1-OXOISOINDOLINES, AND METHOD FOR REDUCING TNF alpha LEVEL See Plans and Pricing
Czech Republic 299812 2,6-Dioxopiperidin a farmaceutick√° kompozice s jeho obsahem (2,6-Dioxopiperidine and pharmaceutical composition containing thereof) See Plans and Pricing
Russian Federation 2209207 2,6-DIOXOPIPERIDINE, METHOD FOR REDUCTION OF UNDESIRABLE LEVELS OF TNF-ALPHA IN MAMMAL, PHARMACEUTICAL COMPOSITION See Plans and Pricing
New Zealand 594557 FORMULATIONS OF 4-AMINO-2-(2,6-DIOXOPIPERIDINE-3-YL)ISOINDOLINE-1,3-DIONE See Plans and Pricing
South Korea 20050010815 See Plans and Pricing
Japan 2005530784 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for POMALYST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0925294 SZ 56/2007 Austria See Plans and Pricing 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
2105135 5/2015 Austria See Plans and Pricing PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 C20150005 00140 Estonia See Plans and Pricing PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
2105135 CA 2015 00006 Denmark See Plans and Pricing PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
0925294 SPC/GB07/047 United Kingdom See Plans and Pricing 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
0925294 91359 Luxembourg See Plans and Pricing 91359, EXPIRES: 20220614
2105135 C300717 Netherlands See Plans and Pricing 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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