Details for Patent: 8,318,745

Which drugs does patent 8,318,745 protect, and when does it expire?

Patent 8,318,745 protects KUVAN and is included in one NDA.

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

This patent has fifteen patent family members in nine countries.

Summary for Patent: 8,318,745

Title:	Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Abstract:	Crystal forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride, hydrates and solvates and processes for their preparation are provided. These crystal forms are either intermediates for the preparation of stable polymorphic form B or are suitable for solid formulations.
Inventor(s):	Moser; Rudolf (Schaffhausen, CH), Groehn; Viola (Dachsen, CH), Egger; Thomas (Kempthal, CH), Blatter; Fritz (Reinach, CH)
Assignee:	Merck & CIE (Schaffhausen, CH)
Application Number:	12/629,963
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,318,745
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Process;

Drugs Protected by US Patent 8,318,745

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,318,745

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004311544
Australia	2012200512
Canada	2545968
Canada	2678124