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Last Updated: August 11, 2022

Claims for Patent: 9,597,398


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Summary for Patent: 9,597,398
Title:Formulations of bendamustine
Abstract: Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.
Inventor(s): Sundaram; Srikanth (Somerset, NJ)
Assignee: EAGLE PHARMACEUTICALS, INC. (Woodcliff Lake, NJ)
Application Number:15/008,819
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,597,398
Patent Claims: 1. A method of treating cancer or malignant disease in a subject, comprising parenterally administering a volume of about 100 ml or less of a liquid composition comprising: a) from about 0.05 to about 12.5 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof; b) a solubilizer comprising propylene glycol in an amount of from about 0.03 to about 5% by volume of the liquid composition and polyethylene glycol; c) a parenterally acceptable diluent; and optionally d) an antioxidant; over a period of less than or equal to about 10 minutes to a subject in need thereof.

2. The method of claim 1, wherein the volume administered is from about 50 ml to about 65 ml.

3. The method of claim 1, wherein the volume administered is about 50 ml.

4. The method of claim 1, wherein the concentration of bendamustine or pharmaceutically acceptable salt thereof is from about 0.05 mg/ml to about 10 mg/ml.

5. The method of claim 1, wherein the concentration of bendamustine or pharmaceutically acceptable salt thereof is from about 0.1 mg/ml to about 7.0 mg/ml.

6. The method of claim 1, wherein the concentration of bendamustine or pharmaceutically acceptable salt thereof is from about 0.5 mg/ml to about 3.2 mg/ml.

7. The method of claim 1, wherein the concentration of bendamustine or pharmaceutically acceptable salt thereof is about 10 mg/ml.

8. The method of claim 1, wherein the concentration of bendamustine or pharmaceutically acceptable salt thereof is about 5.6 mg/ml.

9. A method of treating cancer or malignant disease in a subject, comprising parenterally administering a volume of about 100 ml or less of a liquid composition comprising: a) from about 0.05 to about 12.5 mg/ml of bendamustine or a pharmaceutically acceptable salt thereof; b) a solubilizer comprising propylene glycol in an amount of from about 0.03 to about 5% by volume of the liquid composition and polyethylene glycol; c) a parenterally acceptable diluent; and optionally d) an antioxidant; over a period of less than or equal to about 20 minutes to a subject in need thereof.

10. The method of claim 9, wherein the composition is administered over a time period of less than or equal to about 15 minutes.

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