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Last Updated: October 24, 2020

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Details for Patent: 8,318,745

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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   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,318,745

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2004311544   Start Trial
Australia 2012200512   Start Trial
Canada 2545968   Start Trial
Canada 2678124   Start Trial
Canada 2678125   Start Trial
Canada 2678165   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Baxter
Harvard Business School
Colorcon
Medtronic

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