IP Library › Granted Patent US 12,343,333
Granted Patent B2
US 12,343,333 · App. 18/646,329 · Granted Jul 1, 2025

Formulations of bendamustine

Inventors: Nagesh R. Palepu (Southampton, PA); Philip Christopher Buxton (Uxbridge, GB)
Assignee: Eagle Pharmaceuticals, Inc.
A61K31/4184A61K9/08A61K47/10A61K47/12A61K47/18A61K47/20A61K47/22A61K9/0019
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Quick Facts
Patent No.
US 12,343,333
App. No.
18/646,329
Granted
Jul 1, 2025
Kind
B2
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.

Claims (27)

1. A method of treating cancer in a human in need thereof comprising providing a liquid bendamustine-containing composition comprising

bendamustine, or a pharmaceutically acceptable salt thereof, wherein the bendamustine concentration in the composition is from about 20 mg/mL to about 60 mg/mL,

a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and

a stabilizing amount of an antioxidant

wherein the total impurities in the liquid bendamustine-containing composition resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. to about 25° C.;

diluting the liquid bendamustine containing composition; and

intravenously administering the diluted composition to the human.

2. The method of claim 1 , wherein the liquid bendamustine containing composition is diluted with about 50 mL of a diluent.

3. The method of claim 1 , wherein the concentration of bendamustine in the liquid bendamustine-containing compositions is about 25 mg/ml.

4. The method of claim 1 , wherein the concentration of bendamustine in the liquid bendamustine-containing composition is 25 mg/ml.

5. The method of claim 1 , wherein the liquid bendamustine-containing composition includes 100 mg of bendamustine at a concentration of 25 mg/mL.

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

7. The method of claim 1 , wherein the antioxidant in the liquid bendamustine containing composition is monothioglycerol in a concentration of about 5 mg/mL.

8. The method of claim 1 , wherein the liquid bendamustine-containing composition is stable for at least about 15 months at 5° C. or for at least about 15 months at 25° C., prior to dilution.

9. The method of claim 1 , wherein the liquid bendamustine-containing composition further comprises ethanol.

10. The method of claim 1 , wherein the liquid bendamustine-containing composition is packages in a sterile vial.

11. A method of treating cancer in a human in need thereof comprising

providing a liquid bendamustine-containing composition packaged in a sterile vial and comprising

100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, at a concentration of about 25 mg/ml;

a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and

a stabilizing amount of an antioxidant that is monothioglycerol;

wherein the total impurities in the liquid bendamustine-containing composition resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. or for at least about 15 months at 25° C.;

diluting the liquid bendamustine containing composition with about 50 mL of a diluent;

and intravenously administering the diluted composition to the human.

12. The method of claim 11 , wherein the liquid bendamustine-containing composition comprises 100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, at a concentration of 25 mg/mL.

13. The method of claim 11 , wherein the liquid bendamustine-containing composition further comprises ethanol.

14. The method of claim 11 , wherein the liquid bendamustine containing composition is diluted with about 50 mL of a diluent.

Assignments (3)
GRANT OF SECURITY INTEREST Recorded Feb 18, 2026
From: EAGLE PHARMACEUTICALS, INC
To: ANKURA TRUST COMPANY, LLC.
Reel/Frame 074849/0457 →
RELEASE OF SECURITY INTEREST Recorded Apr 1, 2025
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: EAGLE PHARMACEUTICALS, INC.
Reel/Frame 070703/0524 →
SECURITY INTEREST Recorded Oct 11, 2024
From: EAGLE PHARMACEUTICALS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 068873/0898 →
Continuity (10)
Continuation 18498259 · Oct 31, 2023
Continuation 17412623 · Aug 26, 2021
Continuation 16509920 · Jul 12, 2019
Continuation 16015656 · Jun 22, 2018
Continuation 15432335 · Feb 14, 2017
Continuation 15013436 · Feb 2, 2016
Continuation 14031879 · Sep 19, 2013
Continuation 13016473 · Jan 28, 2011
Provisional Application 61299100 · Jan 28, 2010
Related Publication 20240293373A1 · Sep 5, 2024
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