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Generic Kuvan Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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] [AB]
  • Manufacturer: BIOMARIN PHARM
    Approval date: October 27, 2015
    Strength(s): 500MG/PACKET [RLD] [AB]

KUVAN (sapropterin dihydrochloride - tablet;oral)

Has a generic version of Kuvan been approved?

A generic version of Kuvan has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Kuvan and have been approved by the FDA:

sapropterin dihydrochloride powder;oral

  • Manufacturer: DR REDDYS
    Approval date: March 30, 2021
    Strength(s): 100MG/PACKET [AB]
  • Manufacturer: PAR PHARM INC
    Approval date: August 20, 2019
    Strength(s): 100MG/PACKET [AB], 500MG/PACKET [AB]

sapropterin dihydrochloride tablet;oral

  • Manufacturer: PAR PHARM INC
    Approval date: May 10, 2019
    Strength(s): 100MG [AB]

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: Generic Drug FAQ.

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: METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
    • 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 PATIENTS WITH HYPERPHENYLALANINEMIA (HPA)
      ✓ 
      Sponsor has requested patent be delisted
    • 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 16, 2026
      ✓ 
      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: METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
    • 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
  • Dry blend formulation of tetrahydrobiopterin
    Patent 9,216,178
    Issued: December 22, 2015
    Assignee(s): BioMarin Pharmaceutical Inc.

    Dry blend powder formulations comprising a pharmaceutical formulation containing tetrahydrobiopterin, and methods of making and using the same, are disclosed herein.

    Patent expiration dates:

    • November 1, 2032
      ✓ 
      Drug product
  • Methods and compositions for the treatment of metabolic disorders
    Patent 9,433,624
    Issued: September 6, 2016
    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: METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
  • 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: KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA
    • November 17, 2024
      ✓ 
      Patent use: TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA (HPA)
    • May 17, 2025
      ✓ 
      Pediatric exclusivity

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.