US Patent

US8609707 — Formulations of bendamustine

Method of Use · Assigned to Eagle Pharmaceuticals Inc · Expires 2031-08-11 · 5y remaining

Vulnerability score 51/100 Moderate — design-around opportunities exist

What this patent protects

This patent discloses long-term storage-stable bendamustine-containing compositions 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

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-1971 — bendamustine-hydrochloride
U-1542 — bendamustine-hydrochloride

Patent Metadata

Patent number
US8609707
Jurisdiction
US
Classification
Method of Use
Expires
2031-08-11
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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