US Patent

US8642012 — Methods of treatment using ammonia-scavenging drugs

Method of Use · Assigned to Horizon Therapeutics LLC · Expires 2030-09-22 · 4y remaining

Vulnerability score 56/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects methods for determining and adjusting the dose of ammonia-scavenging drugs, such as Ravicti, based on patient factors like dietary protein intake and urinary nitrogen levels.

USPTO Abstract

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.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-1383 Ravicti

Patent Metadata

Patent number
US8642012
Jurisdiction
US
Classification
Method of Use
Expires
2030-09-22
Drug substance claim
No
Drug product claim
No
Assignee
Horizon Therapeutics LLC
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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