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Details for Patent: 8,062,665

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Which drugs does patent 8,062,665 protect, and when does it expire?

Patent 8,062,665 protects PROMACTA and is included in one NDA.

Protection for PROMACTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-one patent family members in thirty-two countries.

Summary for Patent: 8,062,665

Title:	3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Abstract:	Disclosed are novel pharmaceutical compositions containing 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-- ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.
Inventor(s):	Muller; Francis X (King of Prussia, PA), Kapsi; Shivakumar G (King of Prussia, PA)
Assignee:	GlaxoSmithKline LLC (Philadelphia, PA)
Application Number:	12/607,320
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Process; Use;

Drugs Protected by US Patent 8,062,665

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y
Novartis Pharms Corp	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes					Y

Non-Orange Book US Patents Family Members for Patent 8,062,665

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
8,071,129	3'-[(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)
8,052,993	3'-[(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)
8,828,430	3'-[(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)
8,052,995	3'-[(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)

International Family Members for US Patent 8,062,665

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Ukraine	96261
Taiwan	I538674
Taiwan	201410240
Taiwan	I439267