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Last Updated: July 13, 2024

POMALIDOMIDE - Generic Drug Details


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What are the generic drug sources for pomalidomide and what is the scope of freedom to operate?

Pomalidomide is the generic ingredient in two branded drugs marketed by Breckenridge, Eugia Pharma, Mylan, Teva Pharms Usa, and Bristol, and is included in five NDAs. There are four 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 fifty-seven patent family members in forty-eight countries.

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

Recent Clinical Trials for POMALIDOMIDE

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

SponsorPhase
MegalabsPhase 1
University of ChicagoPhase 2
Regeneron PharmaceuticalsPhase 3

See all POMALIDOMIDE clinical trials

Generic filers with tentative approvals for POMALIDOMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up4MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up3MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up2MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for POMALIDOMIDE
Drug ClassThalidomide Analog
Paragraph IV (Patent) Challenges for POMALIDOMIDE
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 POMALIDOMIDE

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 204026-001 Feb 8, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan POMALIDOMIDE pomalidomide CAPSULE;ORAL 210275-001 Jan 26, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for POMALIDOMIDE

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 POMALIDOMIDE

Country Patent Number Title Estimated Expiration
Morocco 28084 FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1, 3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2, 6-DIONE ⤷  Sign Up
Russian Federation 2010137395 СПОСОБЫ ПРИМЕНЕНИЯ 3-(4-АМИНО-1-ОКСО-1,3-ДИГИДРОИЗОИНДОЛ-2-ИЛ)ПИПЕРИДИН-2,6-ДИОНА ДЛЯ ЛЕЧЕНИЯ ОПРЕДЕЛЕННЫХ ТИПОВ ЛЕЙКОЗА ⤷  Sign Up
Croatia P20170179 ⤷  Sign Up
Peru 20070761 3-(4-AMINO-1-OXO-1,3-DIHIDRO-ISOINDOL-2-IL)-PIPERIDINA-2,6,-DIONA PARA EL TRATAMIENTO DE CIERTAS LEUCEMIAS ⤷  Sign Up
Japan 2013126999 METHOD AND COMPOSITION FOR TREATMENT AND MANAGEMENT OF CANCER AND OTHER DISEASES BY USING IMMUNOMODULATORY COMPOUND ⤷  Sign Up
China 1697655 Methods and compositions using immunomodulatory compounds for treatment and management of cancers and other diseases ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for POMALIDOMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 300717 Netherlands ⤷  Sign Up PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 CA 2015 00006 Denmark ⤷  Sign Up PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2105135 C300717 Netherlands ⤷  Sign Up PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 122015000013 Germany ⤷  Sign Up PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 00140 Estonia ⤷  Sign Up
2105135 C20150005 00140 Estonia ⤷  Sign Up PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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