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Serving leading biopharmaceutical companies globally:

Novartis
Cipla
Fuji
Julphar
Queensland Health
US Department of Justice
Moodys
US Army
Harvard Business School
Federal Trade Commission

Generated: November 23, 2017

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Eltrombopag olamine - Generic Drug Details

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What are the generic sources for eltrombopag olamine and what is the scope of eltrombopag olamine patent protection?

Eltrombopag olamine
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for eltrombopag olamine. Two suppliers are listed for this compound.
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;ORAL022291-003Sep 8, 2009RXYesYes► Subscribe► Subscribe► Subscribe
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
FOR SUSPENSION;ORAL207027-001Aug 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
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► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: eltrombopag olamine

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
7,335,649Thrombopoietin mimetics► 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
7,674,887Thrombopoietin 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
6,211,200 Metal complexes► Subscribe
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal► Subscribe
7,648,971Thrombopoietin mimetics► Subscribe
7,439,342Thrombopoietin mimetics► 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 Ingredient: eltrombopag olamine

Country Document Number Estimated Expiration
Israel193617► Subscribe
Japan2003534257► Subscribe
South Korea101537200► Subscribe
Norway20045561► Subscribe
Hungary0800710► Subscribe
Spain2338108► Subscribe
TaiwanI439267► Subscribe
New Zealand533308► Subscribe
Costa Rica11143► Subscribe
Malaysia142390► 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: ELTROMBOPAG OLAMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C020/2010Ireland► SubscribeSPC020/2010: 20110308, EXPIRES: 20250310
/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
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
3-2010Slovakia► SubscribeFORMER OWNER: GLAXO GROUP LIMITED, BRENTFORD, MIDDLESEX, GB; DATUM ZAPISU DO REGISTRA: 20161202
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
681Luxembourg► Subscribe91681, EXPIRES: 20250311
00451Netherlands► SubscribePRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Express Scripts
Covington
Mallinckrodt
Teva
Deloitte
Cantor Fitzgerald
Moodys
Fish and Richardson

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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