DrugPatentWatch Database Preview

Details for Patent: 8,158,645

Which drugs does patent 8,158,645 protect, and when does it expire?

Patent 8,158,645 protects HYCAMTIN and is included in one NDA.

This patent has eighteen patent family members in sixteen countries.

Summary for Patent: 8,158,645

Title:	Compound, corresponding compositions, preparation and/or treatment methods
Abstract:	Disclosed is a novel crystalline form of topotecan monohydrochloride pentahydrate, which is a pentahydrate of 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indo- lizino[1,2-b]quinoline-3,14(4H,12H)dione monohydrochloride, corresponding pharmaceutical compositions, methods preparation and/or use thereof to treat anti-viral and/or cancer-related diseases.
Inventor(s):	Dell'Orco; Philip C. (King of Prussia, PA), Diederich; Ann Marie (King of Prussia, PA), Su; Qiaogong (King of Prussia, PA), Wood; Jeffery Lee (King of Prussia, PA)
Assignee:	GlaxoSmithKline LLC (Philadelphia, PA)
Application Number:	12/770,898
Patent Claim Types: see list of patent claims	Composition; Compound; Process; Formulation;

Drugs Protected by US Patent 8,158,645

Glossary

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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	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y				➤ Sign Up
Novartis Pharms Corp	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-002	Oct 11, 2007		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y				➤ Sign Up
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

Non-Orange Book US Patents Family Members for Patent 8,158,645

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.

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Patent No.	Title	Estimated Patent Expiration
7,754,733	Crystalline topotecan hydrochloride product and process for making the same	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Family Members for US Patent 8,158,645

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Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	046579	➤ Sign Up
Australia	2004289318	➤ Sign Up
Brazil	PI0416366	➤ Sign Up
Canada	2545876	➤ Sign Up
Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration

Summary for Patent: 8,158,645

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