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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-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
|Drug Master File Entries:||3|
|Suppliers / Packagers:||3|
|Bulk Api Vendors:||54|
|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
|Censa Pharmaceuticals, Inc.||Phase 1/Phase 2|
|Merck KGaA||Phase 2|
|BioMarin Pharmaceutical||Phase 4|
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
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Biomarin Pharm||KUVAN||sapropterin dihydrochloride||POWDER;ORAL||205065-001||Dec 19, 2013||AB||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Biomarin Pharm||KUVAN||sapropterin dihydrochloride||TABLET;ORAL||022181-001||Dec 13, 2007||AB||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Biomarin Pharm||KUVAN||sapropterin dihydrochloride||POWDER;ORAL||205065-002||Oct 27, 2015||AB||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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