IP Library Granted Patent US 10,052,385
Granted Patent B2
US 10,052,385 · App. 15/432,378 · Granted Aug 21, 2018

Formulations of bendamustine

Inventor: Srikanth Sundaram (Somerset, NJ)
Assignee: EAGLE PHARMACEUTICALS, INC.
A61K47/10A61K9/0019A61K31/4184A61K47/02A61K47/20A61K47/22
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Quick Facts
Patent No.
US 10,052,385
App. No.
15/432,378
Granted
Aug 21, 2018
Kind
B2
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.

Claims (14)

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.

Assignments (4)
GRANT OF SECURITY INTEREST Recorded Feb 18, 2026
From: EAGLE PHARMACEUTICALS, INC
To: ANKURA TRUST COMPANY, LLC.
Reel/Frame 074849/0457 →
SECURITY INTEREST Recorded May 14, 2025
From: EAGLE SUBI LLC, A DELAWARE CORPORATION
To: LSI FINANCING LLC
Reel/Frame 071275/0866 →
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 Aug 21, 2017
From: EAGLE PHARMACEUTICALS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 043346/0871 →
Continuity (6)
Continuation 14857064 · Sep 17, 2015
Continuation 14714578 · May 18, 2015
Continuation 13838090 · Mar 15, 2013
Provisional Application 61613173 · Mar 20, 2012
Provisional Application 61669889 · Jul 10, 2012
Related Publication 20180000938A1 · Jan 4, 2018
Cited By (3)
US 12,208,086 US 12,343,333 US 12,419,867