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Last Updated: September 22, 2021

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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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 ⤷  Free Forever Trial
Australia 2012200512 ⤷  Free Forever Trial
Canada 2545968 ⤷  Free Forever Trial
Canada 2678124 ⤷  Free Forever Trial
Canada 2678125 ⤷  Free Forever Trial
Canada 2678165 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Johnson and Johnson
Dow
AstraZeneca
Mallinckrodt

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