IP Library Granted Patent US 7,960,424
Granted Patent B2
US 7,960,424 · App. 11/388,270 · Granted Jun 14, 2011

Liquid pharmaceutical formulations of palonosetron

Assignees: Helsinn Healthcare S.A.; Roche Palo Alto LLC
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Quick Facts
Patent No.
US 7,960,424
App. No.
11/388,270
Granted
Jun 14, 2011
Kind
B2
Abstract

The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.

Claims (11)

1. A pharmaceutically stable isotonic intravenous solution of palonosetron hydrochloride for reducing emesis or reducing the likelihood of emesis comprising

a) from about 0.03 mg/mL to about 0.2 mg/mL palonosetron as palonosetron hydrochloride,

b) a sterile pharmaceutically acceptable aqueous carrier comprising mannitol as a tonicity agent, at a pH of from 4.0 to 6.0, and

c) EDTA in an amount of from 0.005 to 1.0 mg/mL.

2. The solution of claim 1 wherein the palonosetron is in a concentration of about 0.05 mg/mL as palonosetron hydrochloride.

3. The solution of claim 1 wherein the pH is from 4.5 to 5.5.

4. The solution of claim 1 wherein the pharmaceutically acceptable carrier further comprises citric acid.

5. The solution of claim 1 wherein:

a) said palonosetron is present in a concentration of 0.05 mg/ml, as palonosetron hydrochloride; and

b) said EDTA is present in a concentration of from 0.005 to 1.0 mg/ml.

6. The solution of claim 5 wherein said pH is from 4.5 to 5.5.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Sep 20, 2023
From: HAMILTON SA LLC
To: HELSINN HEALTHCARE SA; HELSINN THERAPEUTICS (U.S.), INC.; HELSINN BIREX PHARMACEUTICALS LIMITED
Reel/Frame 064961/0567 →
SECURITY INTEREST Recorded Dec 30, 2022
From: HELSINN HEALTHCARE SA; HELSINN THERAPEUTICS (U.S.), INC.; HELSINN BIREX PHARMACEUTICALS LIMITED
To: HAMILTON SA LLC
Reel/Frame 062254/0888 →
CORRECTIVE ASSIGNMENT TO CORRECT THE 1. SPELLING OF ASSIGNEE NAME HELSINN BIREX PHARMACEUTICALS LTD.; 2. ADDRESSES OF ASSIGNEES PREVIOUSLY RECORDED ON REEL 047534 FRAME 0024. ASSIGNOR(S) HEREBY CONFIRMS THE PATENT CO-OWNERSHIP AGREEMENT. Recorded Nov 21, 2018
From: HELSINN HEALTHCARE SA
To: HELSINN ADVANCED SYNTHESIS SA; HELSINN BIREX PHARMACEUTICALS, LTD.; HELSINN THERAPEUTICS (U.S.), INC.
Reel/Frame 047617/0285 →
PATENT CO-OWNERSHIP AGREEMENT Recorded Nov 14, 2018
From: HELSINN HEALTHCARE SA
To: HELSINN ADVANCED SYNTHESIS SA; HELSINN BIREX PHARMACEUTIALS LTD.; HELSINN THERAPEUTICS (U.S.), INC.
Reel/Frame 047534/0024 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2016
From: ROCHE PALO ALTO LLC
To: HELSINN HEALTHCARE SA
Reel/Frame 038544/0269 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2011
From: CALDERARI, GIORGIO; BONADEO, DANIEL; BRAGLIA, ENRICO; BRAGLIA, RICCARDO; CANNELLA, ROBERTA
To: HELSINN HEALTHCARE SA
Reel/Frame 025816/0283 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2011
From: MIKSZTAL, ANDREW; MALEFYT, THOMAS; LEE, KATHLEEN M.
To: ROCHE PALO ALTO LLC
Reel/Frame 025816/0579 →
Continuity (4)
Continuation 11186311 · Jul 21, 2005
Continuation PCTEP2004000888 · Jan 30, 2004
Provisional Application 60444351 · Jan 30, 2003
Related Publication 20060167073A1 · Jul 27, 2006