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Generated: September 26, 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 seventy-eight patent family members in forty-one countries.

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

Summary for Generic Name: eltrombopag olamine

Tradenames:1
Patents:14
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packagers: see list2
Bulk Api Vendors: see list48
Clinical Trials: see list104
Patent Applications: see list114
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:eltrombopag olamine 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
FOR SUSPENSION;ORAL207027-001Aug 24, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-003Sep 8, 2009RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 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;ORAL022291-003Sep 8, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-005Nov 16, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PROMACTA
eltrombopag olamine
TABLET;ORAL022291-001Nov 20, 2008RXYesNo► 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
6,211,200 Metal complexes► 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
7,648,971Thrombopoietin 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
7,439,342Thrombopoietin 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
Australia748063► Subscribe
Israel193618► Subscribe
Malaysia158072► Subscribe
China100423721► Subscribe
Hungary0800310► Subscribe
Hong Kong1113057► Subscribe
Israel193619► Subscribe
China101343251► Subscribe
South Korea100798568► Subscribe
TaiwanI280128► 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
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
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
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
00451Netherlands► SubscribePRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; 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
/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
2010000037Germany► SubscribePRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
681Luxembourg► Subscribe91681, EXPIRES: 20250311
1294378/01Switzerland► SubscribeFORMER OWNER: GLAXOSMITHKLINE LLC, US
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Cipla
Queensland Health
Baxter
Mallinckrodt
US Army
Medtronic
Express Scripts
Cantor Fitzgerald
Teva

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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