US Patent

US12370163 — Levodopa dosing regimen

Method of Use · Assigned to Amneal Pharmaceuticals LLC · Expires 2041-12-21 · 16y remaining

Vulnerability score 58/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects a method of treating levodopa-naive patients with Parkinson's disease by administering a controlled-release levodopa formulation twice a day.

USPTO Abstract

The invention is a method for treating levodopa naïve patients with Parkinson's disease by orally administering a controlled release levodopa formulation twice a day to the levodopa naïve patient and the method provides an improvement of a patient's motor state as determined by patient's Parkinson's disease diary, provides a reduction of from about 10%-40% in the patient's tremor, dyskinesia, and/or mobility and/or provides a reduction in the patient's Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores by at least 3 points.

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-1649 — Sinemet Cr
U-1649 — Sinemet Cr
U-1649 — Sinemet Cr
U-1649 — Sinemet Cr

Patent Metadata

Patent number
US12370163
Jurisdiction
US
Classification
Method of Use
Expires
2041-12-21
Drug substance claim
No
Drug product claim
No
Assignee
Amneal Pharmaceuticals 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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