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Last Updated: March 28, 2024

Sapropterin dihydrochloride - Generic Drug Details


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What are the generic drug sources for sapropterin dihydrochloride and what is the scope of patent protection?

Sapropterin dihydrochloride is the generic ingredient in two branded drugs marketed by Biomarin Pharm, Annora Pharma, Dr Reddys, and Par Pharm Inc, and is included in ten NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has one hundred and seventeen patent family members in twenty-six countries.

There is one drug master file entry for sapropterin dihydrochloride. Six suppliers are listed for this compound.

Drug Prices for sapropterin dihydrochloride

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Recent Clinical Trials for sapropterin dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
West China HospitalPhase 1
University of PittsburghPhase 1/Phase 2
Ira FoxPhase 1/Phase 2

See all sapropterin dihydrochloride clinical trials

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KUVAN Powder for Oral Solution sapropterin dihydrochloride 500 mg per packet 205065 1 2017-02-23
KUVAN Powder for Oral Solution sapropterin dihydrochloride 100 mg per packet 205065 1 2015-11-09
KUVAN Tablets sapropterin dihydrochloride 100 mg 022181 1 2014-06-05

US Patents and Regulatory Information for sapropterin dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm Inc SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 207200-001 May 10, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Annora Pharma SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 215534-001 Aug 23, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for sapropterin dihydrochloride

Country Patent Number Title Estimated Expiration
Israel 201101 טטרהידרוביופטרין לשימוש בטיפול בהיפרפנילאלנינמיה על ידי מתן פומי מ-5 עד 20 דקות אחרי ארוחה (Tetrahydrobiopterin for use in treating hyperphenylalaninemia by oral administration 5-20 minutes after a meal) ⤷  Try a Trial
Denmark 3138566 ⤷  Try a Trial
China 1905863 Methods and compositions for the treatment of metabolic disorders ⤷  Try a Trial
Hungary E058030 ⤷  Try a Trial
European Patent Office 2545939 Procédés d'administration de la tétrahydrobioptérine, compositions associées et procédés de mesure (Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005049000 ⤷  Try a Trial
Russian Federation 2009141618 КОМПОЗИЦИИ ТЕТРАГИДРОБИОПТЕРИНА И СПОСОБЫ ЕГО КОЛИЧЕСТВЕННОЙ ОЦЕНКИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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