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Sapropterin dihydrochlorideis 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-seven patent family members in twenty-four countries.
There are three drug master file entries for sapropterin dihydrochloride. One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for sapropterin dihydrochloride
|Drug Master File Entries:||3|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||70|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for sapropterin dihydrochloride|
|DailyMed Link:||sapropterin dihydrochloride at DailyMed|
Recent Clinical Trials for sapropterin dihydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Censa Pharmaceuticals, Inc.||Phase 1/Phase 2|
|Merck KGaA||Phase 2|
|BioMarin Pharmaceutical||Phase 4|
Recent Litigation for sapropterin dihydrochloride
Identify potential future generic entrants
District Court Litigation
|BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.||2015-03-06|
Generic filers with tentative approvals for SAPROPTERIN DIHYDROCHLORIDE
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
Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
|Country||Patent Number||Estimated Expiration|
|Hong Kong||1139864||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.