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Last Updated: November 28, 2020

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Claims for Patent: 10,052,385

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Summary for Patent: 10,052,385
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:15/432,378
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,052,385
Patent Claims: 1. A method of treating chronic lymphocytic leukemia or indolent B-cell non-Hodgkin's lymphoma in a subject in need of treatment comprising: parenterally administering to the subject, over a period of less than or equal to about 15 minutes, about 100 ml or less of a liquid composition comprising: 0.96-5.59 mg/mL of bendamustine or a pharmaceutically acceptable salt thereof; 3.8-22.4 vol % of a nonaqueous component comprising polyethylene glycol and propylene glycol; a parenterally acceptable diluent; and optionally an antioxidant.

2. The method of claim 1, wherein the subject is human.

3. The method of claim 1, wherein the composition is administered in about 10 minutes.

4. The method of claim 1, comprising administering about 50 ml of the composition.

5. The method of claim 1, wherein the polyethylene glycol is PEG 400.

6. The method of claim 1, wherein the weight ratio of polyethylene glycol to propylene glycol is about 90:10.

7. The method of claim 1, wherein the antioxidant is monothioglycerol.

8. The method of claim 1, for the treatment of chronic lymphocytic leukemia.

9. The method of claim 1, for the treatment of indolent B-cell non-Hodgkin's lymphoma.

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