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Details for Patent: 8,754,257

Which drugs does patent 8,754,257 protect, and when does it expire?

Patent 8,754,257 protects AURYXIA and is included in one NDA.

This patent has seventy-three patent family members in twenty countries.

Summary for Patent: 8,754,257

Title:	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Abstract:	The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
Inventor(s):	Chan; Keith (Rockville, MD), Town; Winston (Hong Kong, CN)
Assignee:	Panion & BF Biotech Inc. (TW)
Application Number:	13/661,558
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,754,257

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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
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		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 8,754,257

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
8,846,976	Ferric organic compounds, uses thereof and methods of making same	➤ Sign Up
8,299,298	Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same	➤ Sign Up
7,767,851	Ferric organic compounds, uses thereof and methods of making same	➤ Sign Up
8,754,258	Ferric organic compounds, uses thereof and methods of making same	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Family Members for US Patent 8,754,257

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Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004213819	➤ Sign Up
Australia	2006279333	➤ Sign Up
Australia	2007210090	➤ Sign Up
Australia	2007210096	➤ Sign Up
Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration

Summary for Patent: 8,754,257

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