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Generated: June 26, 2017
What are the generic drug sources for pomalidomide and what is the scope of pomalidomide patent protection?
Pomalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 124 |
| Patent Applications: see list | 354 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | pomalidomide at DailyMed |
| Drug Class | Thalidomide Analog |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | RX | Yes | Yes | 6,476,052 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | RX | Yes | No | 8,626,531 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | RX | Yes | No | 8,198,262 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | RX | Yes | No | 6,315,720 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | RX | Yes | Yes | 6,561,977 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | 6,316,471 | ► Subscribe | ||||||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | 8,158,653 | ► Subscribe | ||||||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | 5,635,517 | ► Subscribe | ||||||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | 6,316,471 | ► Subscribe | ||||||||||||||||||||||
Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | 6,476,052 | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,393,862 | Method using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias | ► Subscribe | |||||||||||||||||||||||||||
| 7,465,800 | Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione | ► Subscribe | |||||||||||||||||||||||||||
| 8,198,306 | Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a proteasome inhibitor | ► Subscribe | |||||||||||||||||||||||||||
| 6,395,754 | Substituted 2-(2,6-dioxopiperidin-3-yl)- phthalimides and 1-oxoisoindolines and method of reducing TNF.alpha. levels | ► Subscribe | |||||||||||||||||||||||||||
| 6,869,399 | Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2004512617 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1425167 | ► Subscribe | |||||||||||||||||||||||||||
| Finland | 990101 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2009200257 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1635826 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 642 | Luxembourg | ► Subscribe | PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805 | ||||||||||||||||||||||||||
| C0056 | France | ► Subscribe | PRODUCT NAME: IENALIDOMIDE EVENTUELLEMENT SOUS LA FORME D?UN DE SES SELS D?ADDITION D?ACIDES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/391/001 DU 20070614; REGISTRATION NO/DATE AT EEC: EU/1/07/391/001-004 DU 20070614 | ||||||||||||||||||||||||||
| 359 | Luxembourg | ► Subscribe | 91359, EXPIRES: 20220614 | ||||||||||||||||||||||||||
| 2015 00006 | Denmark | ► Subscribe | PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805 | ||||||||||||||||||||||||||
| 56/2007 | Austria | ► Subscribe | PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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