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Generic Ravicti Availability

Ravicti is a brand name of glycerol phenylbutyrate, approved by the FDA in the following formulation(s):

RAVICTI (glycerol phenylbutyrate - liquid;oral)

  • Manufacturer: HORIZON THERAPS INC
    Approval date: February 1, 2013
    Strength(s): 1.1GM/ML [RLD]

Has a generic version of Ravicti been approved?

No. There is currently no therapeutically equivalent version of Ravicti available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ravicti. 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.

  • Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders
    Patent 5,968,979
    Issued: October 19, 1999
    Inventor(s): Brusilow; Saul W.
    Assignee(s): Brusilow Enterprises LLC
    Two new forms of prodrug for phenylacetate, of even congeners of phenylalkanoic acid and phenylalkenoic acids, which are the phenylalkanoic or phenylalkenoic esters of glycerol, or the ethyl esters of phenylalkanoic acid or phenylalkenoic acids. These forms of the drugs provide a convenient dosage form of the drugs. The prodrugs of the invention are useful to treat patients with diseases of nitrogen accumulation, patients with certain .beta.-hemoglobinopathies, anemia, and cancer.
    Patent expiration dates:
    • July 28, 2018
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      Patent use: TREATMENT OF A NITROGEN METABOLISM DISORDER
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      Drug substance
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      Drug product
  • Methods of therapeutic monitoring of nitrogen scavenging
    Patent 8,404,215
    Issued: March 26, 2013
    Assignee(s): Hyperion Therapeutics, Inc.
    The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
    Patent expiration dates:
    • March 9, 2032
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      Patent use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
  • Methods of treatment using ammonia-scavenging drugs
    Patent 8,642,012
    Issued: February 4, 2014
    Assignee(s): Hyperion Therapeutics, Inc.
    The invention provides a method for determining a dose and schedule and making dose adjustments of PBA prodrugs used to treat nitrogen retention states, or ammonia accumulation disorders, by measuring urinary excretion of phenylacetylglutamine and/or total urinary nitrogen. The invention provides methods to select an appropriate dosage of a PBA prodrug based on the patient's dietary protein intake, or based on previous treatments administered to the patient. The methods are applicable to selecting or modifying a dosing regimen for a subject receiving an orally administered ammonia scavenging drug.
    Patent expiration dates:
    • September 22, 2030
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      Patent use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
  • Methods of therapeutic monitoring of nitrogen scavenging drugs
    Patent 9,095,559
    Issued: August 4, 2015
    Assignee(s): HORIZON THERAPEUTICS, INC.
    The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
    Patent expiration dates:
    • March 9, 2032
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      Patent use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
  • Methods of therapeutic monitoring of nitrogen scavenging drugs
    Patent 9,254,278
    Issued: February 9, 2016
    Assignee(s): Horizon Therapeutics, Inc.
    The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
    Patent expiration dates:
    • March 9, 2032
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      Patent use: TREATMENT OF A UREA CYCLE DISORDER
  • Methods of therapeutic monitoring of nitrogen scavenging drugs
    Patent 9,326,966
    Issued: May 3, 2016
    Assignee(s): Horizon Therapeutics, Inc.
    The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
    Patent expiration dates:
    • March 9, 2032
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      Patent use: TREATMENT OF A UREA CYCLE DISORDER

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:
    • February 1, 2016 - NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
    • February 1, 2020 - ORPHAN DRUG EXCLUSIVITY

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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