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Generated: July 21, 2017
What is the patent landscape for Promacta, and what generic Promacta alternatives are available?
Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this drug and two Paragraph IV challenges.| Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 47 |
| Clinical Trials: see list | 25 |
| Patent Applications: see list | 82 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | PROMACTA at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | 8,828,430*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | 7,790,704*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | 7,790,704*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| eltrombopag olamine | Tablets | 50 mg and 75 mg | Promacta | 1/7/2014 |
| eltrombopag olamine | Tablets | 12.5 mg and 25 mg | Promacta | 2/4/2014 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,846,024 | 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) | ► Subscribe | |||||||||||||||||||||||||||
| 7,648,971 | Thrombopoietin mimetics | ► Subscribe | |||||||||||||||||||||||||||
| 7,674,887 | Thrombopoietin mimetics | ► Subscribe | |||||||||||||||||||||||||||
| 8,088,813 | 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) | ► Subscribe | |||||||||||||||||||||||||||
| 6,211,200 | Metal complexes | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2001274938 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 020883 | ► Subscribe | |||||||||||||||||||||||||||
| Morocco | 30236 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 2770 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2003241587 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010 00017 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 3-2010 | Slovakia | ► Subscribe | FORMER OWNER: GLAXO GROUP LIMITED, BRENTFORD, MIDDLESEX, GB; DATUM ZAPISU DO REGISTRA: 20161202 | ||||||||||||||||||||||||||
| 8 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| /2010 | Austria | ► Subscribe | PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311 | ||||||||||||||||||||||||||
| C/GB10/026 | United Kingdom | ► Subscribe | PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311 | ||||||||||||||||||||||||||
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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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