You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

POMALIDOMIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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-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
University of ChicagoPhase 2
Regeneron PharmaceuticalsPhase 3
Onward TherapeuticsPhase 1

See all POMALIDOMIDE clinical trials

Generic filers with tentative approvals for POMALIDOMIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial4MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial3MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial2MGCAPSULE;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 204026-002 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 ⤷  Try a Trial
Mylan POMALIDOMIDE pomalidomide CAPSULE;ORAL 210275-002 Jan 26, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan POMALIDOMIDE pomalidomide CAPSULE;ORAL 210275-001 Jan 26, 2022 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

Expired US Patents for POMALIDOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol POMALYST pomalidomide CAPSULE;ORAL 204026-002 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 204026-001 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
>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
Ukraine 89474 СПОСОБЫ И КОМПОЗИЦИИ С ИСПОЛЬЗОВАНИЕМ ИММУНОМОДУЛИРУЮЩИХ СОЕДИНЕНИЙ ДЛЯ ЛЕЧЕНИЯ И ПОДДЕРЖКИ СОСТОЯНИЯ ПРИ РАКЕ И ДРУГИХ ЗАБОЛЕВАНИЯХ;СПОСОБИ І КОМПОЗИЦІЇ З ВИКОРИСТАННЯМ ІМУНОМОДУЛЮЮЧИХ СПОЛУК ДЛЯ ЛІКУВАННЯ І ПІДТРИМКИ СТАНУ ПРИ РАКУ І ІНШИХ ЗАХВОРЮВАННЯХ (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES) ⤷  Try a Trial
Austria 531369 ⤷  Try a Trial
Brazil PI0414084 composto, mistura, e, composição ⤷  Try a Trial
South Korea 20060087543 POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for POMALIDOMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.