Glycerol Phenylbutyrate Patent Expiration
Glycerol Phenylbutyrate is Used for managing urea cycle disorders and nitrogen metabolism disorders. It was first introduced by Horizon Therapeutics Us Holding Llc
Glycerol Phenylbutyrate Patents
Given below is the list of patents protecting Glycerol Phenylbutyrate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Ravicti | US8404215 | Methods of therapeutic monitoring of nitrogen scavenging | Mar 09, 2032 | Horizon Therap Us |
| Ravicti | US9095559 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Mar 09, 2032 | Horizon Therap Us |
| Ravicti | US10045958 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10045959 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10183002 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10183003 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10183004 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10183005 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10183006 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US10668040 | Treatment of urea cycle disorders in neonates and infants | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US8642012 | Methods of treatment using ammonia-scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US9254278 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US9326966 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US9561197 | Methods of therapeutic monitoring of phenylacetic acid prodrugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US9962359 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US9999608 | Methods of therapeutic monitoring of nitrogen scavenging drugs | Sep 22, 2030 | Horizon Therap Us |
| Ravicti | US5968979 | Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders |
Feb 07, 2015
(Expired) | Horizon Therap Us |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Glycerol Phenylbutyrate's patents.
Latest Legal Activities on Glycerol Phenylbutyrate's Patents
Given below is the list recent legal activities going on the following patents of Glycerol Phenylbutyrate.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jan, 2026 | US10045958 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jan, 2026 | US10045959 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Nov, 2025 | US9999608 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Oct, 2025 | US9962359 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jul, 2025 | US8642012(Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Sep, 2024 | US8404215 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jul, 2024 | US9561197 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2023 | US10668040 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Oct, 2023 | US9326966(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Aug, 2023 | US9254278(Litigated) |
Glycerol Phenylbutyrate's Family Patents
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Clinical Trials
Recent Clinical Trials on Glycerol Phenylbutyrate:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
| ||||
| PROFIL Study to Investigate the Effect of GPB on NfL Levels in Patients With Corticobasal Syndrome (CBS) | Technical University of Munich | NA |
COMPLETED
(Aug 1, 2026)
| PHASE2 |
| Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis) | National Jewish Health | NA |
TERMINATED
(Apr 1, 2026)
| PHASE1, PHASE2 |
| Efficacy and Safety of the Treatment of Pyruvate Dehydrogenase Deficiency Patients With Glycerol Phenylbutyrate (RAVICTI) | Assistance Publique - Hôpitaux de Paris | NA |
RECRUITING
(Mar 1, 2026)
| PHASE2 |