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Sapropterin dihydrochlorideis the generic ingredient in two branded drugs marketed by Biomarin Pharm, Dr Reddys, and Par Pharm Inc, and is included in seven 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 ninety-six patent family members in twenty-five countries.
There are three drug master file entries for sapropterin dihydrochloride. Four suppliers are listed for this compound.
Summary for sapropterin dihydrochloride
|Drug Master File Entries:||3|
|Finished Product Suppliers / Packagers:||4|
|Raw Ingredient (Bulk) Api Vendors:||58|
|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
|University of Massachusetts, Worcester||Phase 1|
|National Institute on Aging (NIA)||Phase 1|
|Censa Pharmaceuticals, Inc.||Phase 1/Phase 2|
Pharmacology for sapropterin dihydrochloride
|Drug Class||Phenylalanine Hydroxylase Activator |
|Mechanism of Action||Phenylalanine Hydroxylase Activators |
Breast Cancer Resistance Protein Inhibitors
Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
|Country||Patent Number||Estimated Expiration|
|Slovenia||2139485||⤷ Free Forever Trial|
|Cyprus||1113543||⤷ Free Forever Trial|
|Australia||2004311544||⤷ Free Forever Trial|
|Lithuania||2545939||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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