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Last Updated: November 30, 2022

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 Celgene, and is included in five NDAs. There are six 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-six 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
Maarten SeefatPhase 4
Institute of Hematology & Blood Diseases HospitalPhase 1
Rajshekhar Chakraborty, MDPhase 1/Phase 2

See all pomalidomide clinical trials

Generic filers with tentative approvals for POMALIDOMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing4MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing3MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing2MGCAPSULE;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
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
Teva Pharms Usa POMALIDOMIDE pomalidomide CAPSULE;ORAL 209956-002 May 4, 2022 AB RX No 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 See Plans and Pricing
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
>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
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
>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 yes 2013-08-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for pomalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 212 50002-2015 Slovakia See Plans and Pricing PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
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
2105135 C20150005 00140 Estonia See Plans and Pricing 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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