Generic Kuvan Availability

Kuvan is a brand name of sapropterin, approved by the FDA in the following formulation(s):

KUVAN (sapropterin dihydrochloride - powder;oral)

  • Manufacturer: BIOMARIN PHARM
    Approval date: December 19, 2013
    Strength(s): 100MG/PACKET [RLD]

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 in the United States.

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
      ✓ 
      Drug product
    • May 16, 2026
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Drug product
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • 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
    • May 17, 2015
      ✓ 
      Pediatric exclusivity
  • 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
      ✓ 
      Patent use: FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride
    Patent 8,318,745
    Issued: November 27, 2012
    Inventor(s): Moser; Rudolf & Groehn; Viola & Egger; Thomas & Blatter; Fritz
    Assignee(s): Merck & CIE
    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
      ✓ 
      Drug product
    • May 17, 2025
      ✓ 
      Pediatric exclusivity
  • Methods of administering tetrahydrobiopterin
    Patent RE43797
    Issued: November 6, 2012
    Inventor(s): Oppenheimer; Daniel I. & Dorenbaum; Alejandro & Okhamafe; Augustus O.
    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
      ✓ 
      Patent use: TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)
    • May 17, 2025
      ✓ 
      Pediatric exclusivity

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, 2014 -
    • June 13, 2015 -
    • April 23, 2017 -
    • October 23, 2017 -

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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