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Eltrombopag olamine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for eltrombopag olamine?

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

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

There are two drug master file entries for eltrombopag olamine. Two suppliers are listed for this compound.

Summary for Generic Name: eltrombopag olamine

Tradenames:1
Patents:23
Applicants:1
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list48
Clinical Trials: see list41
Patent Applications: see list78
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:eltrombopag olamine 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;ORAL022291-005Nov 16, 2012RXYesYes7,547,719*PED► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-004Oct 20, 2011RXYesNo7,547,719*PED► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo7,452,874*PED► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-002Nov 20, 2008RXYesNo8,052,994*PED► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► 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
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
7,335,649Thrombopoietin 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 Ingredient: eltrombopag olamine

Country Document Number Estimated Expiration
South Korea20070087255► Subscribe
European Patent Office1039906► Subscribe
Brazil0111116► Subscribe
New Zealand533308► Subscribe
Hong Kong1136968► 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
C020/2010Ireland► SubscribeSPC020/2010: 20110308, EXPIRES: 20250310
681Luxembourg► Subscribe91681, EXPIRES: 20250311
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
00451Netherlands► SubscribePRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 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
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