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PROMACTA Drug Profile

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Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There are twenty-two patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty-nine patent family members in forty-one countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Summary for Tradename: PROMACTA

Patents:22
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list47
Clinical Trials: see list17
Patent Applications: see list78
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PROMACTA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-003Sep 8, 2009RXYesYes6,280,959*PED► subscribeY► subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► subscribe► subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo7,795,293*PED► subscribeY► subscribe
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Paragraph IV activity for: PROMACTA

Drugname Dosage Strength RLD Submissiondate
eltrombopag olamineTablets50 mg and 75 mgPromacta1/7/2014
eltrombopag olamineTablets12.5 mg and 25 mgPromacta2/4/2014

Non-Orange Book Patents for Tradename: PROMACTA

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
6,211,200 Metal complexes► subscribe
7,439,342Thrombopoietin mimetics► subscribe
8,088,8133'-[(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
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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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International Patent Family for Tradename: PROMACTA

Country Document Number Estimated Expiration
Austria374772► subscribe
African Regional IP Organization (ARIPO)200704090► subscribe
China101342169► 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 Certificates for Tradename: PROMACTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C020/2010Ireland► subscribeSPC020/2010: 20110308, EXPIRES: 20250310
00451Netherlands► subscribePRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
8Finland► subscribe
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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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