Sodium Phenylbutyrate Patent Expiration
Sodium Phenylbutyrate is Used for treating urea cycle disorders involving enzyme deficiencies. It was first introduced by Horizon Therapeutics Us Holding Llc
Sodium Phenylbutyrate Patents
Given below is the list of patents protecting Sodium 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 |
|---|---|---|---|---|
| Olpruva | US11154521 | Palatable compositions including sodium phenylbutyrate and uses thereof | Oct 17, 2036 | Acer |
| Olpruva | US11202767 | Methods of treating urea cycle disorders and maple syrup urine disease | Oct 17, 2036 | Acer |
| Olpruva | US11433041 | Palatable compositions including sodium phenylbutyrate and uses thereof | Oct 17, 2036 | Acer |
Sodium Phenylbutyrate's Family Patents
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Clinical Trials
Recent Clinical Trials on Sodium 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 |
|---|---|---|---|---|
 | ||||
| METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D) | University of Washington | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) | Jerry Vockley, MD, PhD | NA |
SUSPENDED
(Jul 1, 2026)
| PHASE2 |
| Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Pediatric and Adults Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) | Jerry Vockley, MD, PhD | NA |
RECRUITING
(Jun 1, 2026)
| PHASE2 |
| An Individual Patient, Open Label Study to Use ACER-001 to Treat Combined D,L-2 Hydroxyglutaric Aciduria (C-2HGA) | Jerry Vockley, MD, PhD | NA |
ENROLLING BY INVITATION
(Jun 1, 2026)
| PHASE1 |
| AMX0035 and Progressive Supranuclear Palsy | Amylyx Pharmaceuticals Inc. | NA |
COMPLETED
(Apr 1, 2026)
| PHASE2, PHASE3 |