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Last Updated: March 19, 2024

POMALIDOMIDE Drug Patent Profile


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Drug patent expirations by year for POMALIDOMIDE
Recent Clinical Trials for POMALIDOMIDE

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SponsorPhase
University of ChicagoPhase 2
Regeneron PharmaceuticalsPhase 3
Onward TherapeuticsPhase 1

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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
Breckenridge POMALIDOMIDE pomalidomide CAPSULE;ORAL 210111-001 Oct 30, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma POMALIDOMIDE pomalidomide CAPSULE;ORAL 210249-003 Oct 30, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge POMALIDOMIDE pomalidomide CAPSULE;ORAL 210111-004 Oct 30, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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

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