Generic Ravicti Availability

Last updated on Sep 11, 2024.

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

RAVICTI (glycerol phenylbutyrate - liquid;oral)

Manufacturer: HORIZON THERAP US
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.

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.

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,045,958
Issued: August 14, 2018
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,045,959
Issued: August 14, 2018
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,183,002
Issued: January 22, 2019
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,183,003
Issued: January 22, 2019
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,183,004
Issued: January 22, 2019
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,183,005
Issued: January 22, 2019
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 10,183,006
Issued: January 22, 2019
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Treatment of urea cycle disorders in neonates and infants
Patent 10,668,040
Issued: June 2, 2020
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
Nitrogen scavenging drugs such as glycerol phenylbutyrate can be administered safely to infants and toddlers with urea cycle disorders by adjusting the dosage based on one or more biomarkers selected from the group consisting of urinary-PAGN and plasma PAA:PAGN ratio.
Patent expiration dates:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging
Patent 8,404,215
Issued: March 26, 2013
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
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
  ✓
  Patent use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
  ✓
  Sponsor has requested patent be delisted
Methods of treatment using ammonia-scavenging drugs
Patent 8,642,012
Issued: February 4, 2014
Inventor(s): Scharschmidt Bruce
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
  ✓
  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
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 9,326,966
Issued: May 3, 2016
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of phenylacetic acid prodrugs
Patent 9,561,197
Issued: February 7, 2017
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
The present disclosure provides methods for adjusting the dosage of PAA prodrugs (e.g., HPN-100, PBA) based on measurement of PAA and PAGN in plasma and calculating the PAA:PAGN ratio so as to determine whether PAA to PAGN conversion is saturated.
Patent expiration dates:
- September 22, 2030
  ✓
  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 9,962,359
Issued: May 8, 2018
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  Patent use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent 9,999,608
Issued: June 19, 2018
Inventor(s): Scharschmidt Bruce & Mokhtarani Masoud
Assignee(s): Horizon Therapeutics, LLC
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:
- September 22, 2030
  ✓
  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:
- April 28, 2024 - FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE

More about Ravicti (glycerol phenylbutyrate)

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.

Further information

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

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

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