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Sapropterin dihydrochloride - Generic Drug Details
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What are the generic drug sources for sapropterin dihydrochloride and what is the scope of freedom to operate?
Sapropterin dihydrochloride
is the generic ingredient in two branded drugs marketed by Biomarin Pharm and Par Pharm Inc, and is included in five NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sapropterin dihydrochloride has eighty-nine patent family members in twenty-four countries.
There are three drug master file entries for sapropterin dihydrochloride. Three suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for sapropterin dihydrochloride
International Patents: | 89 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 5 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 54 |
Clinical Trials: | 32 |
Patent Applications: | 143 |
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 |
---|---|
Censa Pharmaceuticals, Inc. | Phase 1/Phase 2 |
Merck KGaA | Phase 2 |
BioMarin Pharmaceutical | Phase 4 |
Generic filers with tentative approvals for SAPROPTERIN DIHYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 100MG | TABLET;ORAL |
Start Trial | Start Trial | 100MG/PACKET | POWDER FOR ORAL SOLUTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for sapropterin dihydrochloride
Drug Class | Phenylalanine Hydroxylase Activator |
Mechanism of Action | Phenylalanine Hydroxylase Activators Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors |
Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2017-02-23 |
KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2015-11-09 |
KUVAN | TABLET;ORAL | sapropterin dihydrochloride | 022181 | 2014-06-05 |
US Patents and Regulatory Information for sapropterin dihydrochloride
International Patents for sapropterin dihydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Brazil | PI0416566 | Start Trial |
Russian Federation | 2434870 | Start Trial |
China | 101678025 | Start Trial |
Israel | 182161 | Start Trial |
World Intellectual Property Organization (WIPO) | 2005065018 | Start Trial |
Canada | 2682598 | Start Trial |
Japan | 2007511536 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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