US Patent

US12138248 — Formulations of bendamustine

Formulation · Assigned to Eagle Pharmaceuticals Inc · Expires 2031-01-28 · 5y remaining

Vulnerability score 44/100 Strong — defensible against typical IPR challenges

What this patent protects

This patent protects long-term storage stable formulations of bendamustine hydrochloride with less than 5% total impurities.

USPTO Abstract

Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Drugs covered by this patent

Patent Metadata

Patent number
US12138248
Jurisdiction
US
Classification
Formulation
Expires
2031-01-28
Drug substance claim
No
Drug product claim
Yes
Assignee
Eagle Pharmaceuticals Inc
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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