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.
Summary for sapropterin dihydrochloride
International Patents: | 117 |
US Patents: | 10 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 10 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 38 |
Patent Applications: | 309 |
Drug Prices: | Drug price trends for sapropterin dihydrochloride |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sapropterin dihydrochloride |
What excipients (inactive ingredients) are in sapropterin dihydrochloride? | sapropterin dihydrochloride excipients list |
DailyMed Link: | sapropterin dihydrochloride at DailyMed |
Recent Clinical Trials for sapropterin dihydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
West China Hospital | Phase 1 |
University of Pittsburgh | Phase 1/Phase 2 |
Ira Fox | Phase 1/Phase 2 |
Pharmacology for sapropterin dihydrochloride
Drug Class | Phenylalanine Hydroxylase Activator |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators |
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
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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