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Serving leading biopharmaceutical companies globally:

Citi
US Department of Justice
Julphar
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Deloitte
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Cerilliant

Generated: November 24, 2017

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PROMACTA Drug Profile

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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.

This drug has one hundred and ninety-two patent family members in forty-one countries and fourteen supplementary protection certificates in thirteen countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
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;ORAL022291-003Sep 8, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-003Sep 8, 2009RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-002Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-002Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-002Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
8,846,0243'-[(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
7,439,342Thrombopoietin mimetics► Subscribe
7,648,971Thrombopoietin 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
7,674,887Thrombopoietin mimetics► Subscribe
7,335,649Thrombopoietin mimetics► Subscribe
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal► 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
Poland218617► Subscribe
Czech Republic303176► Subscribe
Malaysia142390► Subscribe
Japan2001521895► Subscribe
Hungary227476► Subscribe
World Intellectual Property Organization (WIPO)9922733► Subscribe
Mexico2009011881► Subscribe
World Intellectual Property Organization (WIPO)03098992► Subscribe
Japan4612414► Subscribe
Germany122010000037► 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
1294378/01Switzerland► SubscribeFORMER OWNER: GLAXOSMITHKLINE LLC, US
2010007Lithuania► SubscribePRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
2010007,C1534390Lithuania► SubscribePRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010-03-11 EU/1/10/612/002, 2010-03-11 EU/1/10/612/003, 2010-03-11 EU/1/10/612/004, 2010-03-11 EU/1/10/612/005, 2010-03-11 EU/1/10/612/006 20100311
/2010Austria► SubscribePRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
681Luxembourg► Subscribe91681, EXPIRES: 20250311
C0034France► SubscribePRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE; REGISTRATION NO/DATE: EU/1/10/612/001 20100311
3-2010Slovakia► SubscribeFORMER OWNER: GLAXO GROUP LIMITED, BRENTFORD, MIDDLESEX, GB; DATUM ZAPISU DO REGISTRA: 20161202
0100006 00032Estonia► SubscribePRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
C/GB10/026United Kingdom► SubscribePRODUCT 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
2010 00017Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Harvard Business School
AstraZeneca
Farmers Insurance
UBS
Covington
Merck
US Department of Justice
Cantor Fitzgerald

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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