POMALYST Drug Patent Profile
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When do Pomalyst patents expire, and what generic alternatives are available?
Pomalyst is a drug marketed by Bristol and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and fifty-seven patent family members in forty-eight countries.
The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.
DrugPatentWatch® Generic Entry Outlook for Pomalyst
Pomalyst was eligible for patent challenges on February 8, 2017.
There have been twenty-eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (pomalidomide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Questions you can ask:
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Summary for POMALYST
International Patents: | 357 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 83 |
Patent Applications: | 2,650 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for POMALYST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for POMALYST |
What excipients (inactive ingredients) are in POMALYST? | POMALYST excipients list |
DailyMed Link: | POMALYST at DailyMed |
Recent Clinical Trials for POMALYST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Megalabs | Phase 1 |
University of Chicago | Phase 2 |
Regeneron Pharmaceuticals | Phase 3 |
Pharmacology for POMALYST
Drug Class | Thalidomide Analog |
Paragraph IV (Patent) Challenges for POMALYST
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 POMALYST
POMALYST is protected by four US patents and five FDA Regulatory Exclusivities.
Patents protecting POMALYST
Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting POMALYST
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷ Sign Up
FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
Exclusivity Expiration: ⤷ Sign Up
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 POMALYST
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bristol | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for POMALYST
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 POMALYST
See the table below for patents covering POMALYST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1956017 | 2-(2,6-dioxopipéridin-3-yl)-phtalimides substituées et procédé pour réduire les niveaux TNF alpha (Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and method of reducing TNF alpha levels) | ⤷ Sign Up |
European Patent Office | 3042659 | FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPÉRIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDROISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE) | ⤷ Sign Up |
Australia | 2004270211 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for POMALYST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2105135 | 00140 | Estonia | ⤷ Sign Up | |
0925294 | SPC/GB07/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619 |
0925294 | CA 2007 00054 | Denmark | ⤷ Sign Up | PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |