Pomalidomide - Generic Drug Details
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What are the generic sources for pomalidomide and what is the scope of patent protection?
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.
Summary for pomalidomide
International Patents: | 356 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 249 |
Patent Applications: | 6,969 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pomalidomide |
What excipients (inactive ingredients) are in pomalidomide? | pomalidomide excipients list |
DailyMed Link: | pomalidomide at DailyMed |
Recent Clinical Trials for pomalidomide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 2 |
Regeneron Pharmaceuticals | Phase 3 |
Onward Therapeutics | Phase 1 |
Generic filers with tentative approvals for POMALIDOMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 4MG | CAPSULE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 3MG | CAPSULE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 2MG | CAPSULE;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 Class | Thalidomide Analog |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eugia Pharma | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210249-004 | Oct 30, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eugia Pharma | POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210249-002 | 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 |
Expired US Patents for pomalidomide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | 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 | 204026-001 | 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 |
---|---|---|---|
San Marino | T201700097 | FORMULAZIONI DI 4-AMMINO-2-(2,6-DIOSSOPIPERIDIN-3-IL)ISOINDOLIN-1,3-DIONE | ⤷ Try a Trial |
Canada | 2505128 | PROCEDES ET COMPOSITIONS UTILISANT DES COMPOSES IMMUNOMODULATEURS POUR TRAITER ET MAITRISER DES CANCERS ET D'AUTRES MALADIES (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES) | ⤷ Try a Trial |
Slovenia | 1505973 | ⤷ Try a Trial | |
Hungary | E041265 | ⤷ 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 | 00140 | Estonia | ⤷ Try a Trial | |
2105135 | 212 50002-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808 |
2105135 | 92642 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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