US Patent

US11850225 — Baclofen formulations and methods of minimizing patient exposure to metabolite variations

Method of Use · Assigned to Amneal Pharmaceuticals LLC · Expires 2041-09-29 · 15y remaining

Vulnerability score 75/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects formulations of the drug Baclofen that minimize variability in patient exposure to its metabolites and are bioequivalent to existing Baclofen tablets.

USPTO Abstract

Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.

Drugs covered by this patent

Lioresal (BACLOFEN)

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.

Code	Description	Drug
`U-3488`	—	Lioresal
`U-3489`	—	Lioresal
`U-3489`	—	Lioresal

Patent Metadata

Patent number: US11850225
Jurisdiction: US
Classification: Method of Use
Expires: 2041-09-29
Drug substance claim: No
Drug product claim: Yes
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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