SAPROPTERIN DIHYDROCHLORIDE Drug Patent Profile
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When do Sapropterin Dihydrochloride patents expire, and when can generic versions of Sapropterin Dihydrochloride launch?
Sapropterin Dihydrochloride is a drug marketed by Annora Pharma, Dr Reddys, and Par Pharm Inc. and is included in eight NDAs.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sapropterin Dihydrochloride
A generic version of SAPROPTERIN DIHYDROCHLORIDE was approved as sapropterin dihydrochloride by PAR PHARM INC on May 10th, 2019.
Summary for SAPROPTERIN DIHYDROCHLORIDE
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 38 |
Patent Applications: | 194 |
Drug Prices: | Drug price information 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
Anatomical Therapeutic Chemical (ATC) Classes for SAPROPTERIN DIHYDROCHLORIDE
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 |