Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Ravicti

(Glycerol Phenylbutyrate)

Small molecule

HHorizon Therapeutics Ireland DAC

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

15

Patents

Clinical

Trials by Indication[1]

Biomarker1 trial

Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain

Completed·UUniversity of Colorado, Denver·Phase 1·NCT02046434·38 enrolled

Unspecified1 trial

Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease

No longer available·UUniversity of Pittsburgh··NCT01949766

Regulatory

FDA Approval Timeline[3]

Feb 1, 2013

RAVICTI

NDA NDA203284

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Glycerol Phenylbutyrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glycerol Phenylbutyrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA203284). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Ravicti. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Horizon Therapeutics Ireland DAC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: HHorizon Therapeutics Ireland DAC

Patent Landscape[4]

Patent Cliff

Sep 22, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9254278Sep 22, 2030

9561197Sep 22, 2030

10183003Sep 22, 2030

10183002Sep 22, 2030

10183004Sep 22, 2030

10 more patents

9962359Sep 22, 2030

8642012Sep 22, 2030

10045959Sep 22, 2030

9999608Sep 22, 2030

9326966Sep 22, 2030

10668040Sep 22, 2030

10183005Sep 22, 2030

10183006Sep 22, 2030

10045958Sep 22, 2030

8404215Mar 9, 2032

Related News