Kuvan is a brand name of sapropterin, approved by the FDA in the following formulation(s):
KUVAN (sapropterin dihydrochloride - tablet; oral)
Manufacturer: BIOMARIN PHARM
Approval date: December 13, 2007
Strength(s): 100MG [RLD]
Has a generic version of Kuvan been approved?
No. There is currently no therapeutically equivalent version of Kuvan available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kuvan. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Stable tablet formulation
Patent 7,566,462
Issued: July 28, 2009
Inventor(s): Jungles; Steven & Henderson; Mark A. & Sluzky; Victoria & Baffi; Robert
Assignee(s): BioMarin Pharmaceutical Inc.
The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations.Patent expiration dates:
- November 16, 2025✓
- November 16, 2025
Methods and compositions for the treatment of metabolic disorders
Patent 7,566,714
Issued: July 28, 2009
Inventor(s): Oppenheimer; Daniel I. & Kakkis; Emil D. & Price; Fredric D. & Dorenbaum; Alejandro & Moser; Rudolf & Groehn; Viola & Egger; Thomas & Blatter; Fritz
Assignee(s): Biomarin Pharmaceutical Inc.
The present invention is directed to a novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. More specifically, the specification describes methods and compositions for treating various types of phenylketonurias using compositions comprising BH4. Combination therapies of BH4 and other therapeutic regimens are contemplated.Patent expiration dates:
- November 17, 2024✓
- November 17, 2024
Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Patent 7,612,073
Issued: November 3, 2009
Inventor(s): Oppenheimer; Daniel I. & Dorenbaum; Alejandro
Assignee(s): Biomarin Pharmaceutical Inc.
The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.Patent expiration dates:
- November 17, 2024✓
- November 17, 2024
Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
Patent 7,727,987
Issued: June 1, 2010
Inventor(s): Moser; Rudolf & Groehn; Viola & Egger; Thomas & Blatter; Fritz
Assignee(s): Merck Eprova AG
Crystal forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride, hydrates and solvates and processes for their preparation are provided. These crystal forms are either intermediates for the preparation of stable polymorphic form B or are suitable for solid formulations.Patent expiration dates:
- November 17, 2024✓
- November 17, 2024
Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Patent 7,947,681
Issued: May 24, 2011
Inventor(s): Oppenheimer; Daniel I. & Dorenbaum; Alejandro & Okhamafe; Augustus & Foehr; Erik & Castillo; Sianna & Kostel; Paul J.
Assignee(s): Biomarin Pharmaceutical Inc.
The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.Patent expiration dates:
- November 17, 2024✓
- November 17, 2024
Stable tablet formulation
Patent 8,003,126
Issued: August 23, 2011
Inventor(s): Jungles; Steven & Henderson; Mark & Sluzky; Victoria & Baffi; Robert
Assignee(s): Biomarin Pharmaceutical Inc.
The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations.Patent expiration dates:
- November 16, 2025
- November 16, 2025
Methods and compositions for the treatment of metabolic disorders
Patent 8,067,416
Issued: November 29, 2011
Inventor(s): Oppenheimer; Daniel I. & Kakkis; Emil D. & Price; Fredric D. & Dorenbaum; Alejandro & Moser; Rudolf & Groehn; Viola & Egger; Thomas & Blatter; Fritz
Assignee(s): Merck Eprova AG
Biomarin Pharmaceutical Inc.
The present invention is directed to a novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. More specifically, the specification describes methods and compositions for treating various types of phenylketonurias using compositions comprising BH4. Combination therapies of BH4 and other therapeutic regimens are contemplated.Patent expiration dates:
- November 17, 2024✓
- November 17, 2024
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- December 13, 2012 - NEW CHEMICAL ENTITY
- December 13, 2014 - ORPHAN DRUG EXCLUSIVITY
See also...
- Kuvan Consumer Information (Drugs.com)
- Kuvan Consumer Information (Wolters Kluwer)
- Kuvan Consumer Information (Cerner Multum)
- Kuvan Advanced Consumer Information (Micromedex)
- Kuvan AHFS DI Monographs (ASHP)
- Sapropterin Consumer Information (Wolters Kluwer)
- Sapropterin Consumer Information (Cerner Multum)
- Sapropterin Advanced Consumer Information (Micromedex)
- Sapropterin Dihydrochloride AHFS DI Monographs (ASHP)
No comments:
Post a Comment