IP Library Granted Patent US 9,308,266
Granted Patent B2
US 9,308,266 · App. 14/070,981 · Granted Apr 12, 2016

Liquid pharmaceutical formulations of palonosetron

Inventors: Giorgio Calderari (Rancate, CH); Daniele Bonadeo (Casalzuigno, IT); Roberta Cannella (Varese, IT); Alberto Macciocchi (Melide, CH); Andrew Miksztal (Palo Alto, CA); Thomas Malefyt (Carmel Valley, CA); Kathleen M Lee (Palo Alto, CA); Carmine Panuccio (Casnate con Bernate, IT)
Assignees: HELSINN HEALTHCARE SA; ROCHE PALO ALTO LLC
A61K47/183A61J3/00A61K9/0019A61K31/4178A61K31/473A61K31/4747A61K47/02A61K47/12A61K47/16A61K47/26B65B3/04B65B55/02
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Quick Facts
Patent No.
US 9,308,266
App. No.
14/070,981
Granted
Apr 12, 2016
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 (7)

1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 50 mL sterile isotonic solution buffered at a pH of 4.8±0.5 comprising:

palonosetron hydrochloride in an amount of 0.75 mg based on the weight of its free base;

450.0 mg sodium chloride;

2.5 mg EDTA;

18.5 mg sodium citrate; and

7.8 mg citric acid monohydrate,

wherein said formulation is contained in a polyethylene multilayer film infusion bag comprising an isoprene rubber stopper.

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 Nov 14, 2018
From: CALDERARI, GIORGIO; BONADEO, DANIELE; CANNELLA, ROBERTA; MACCIOCCHI, ALBERTO; PANUCCIO, CARMINE
To: HELSINN HEALTHCARE SA
Reel/Frame 047498/0916 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 14, 2018
From: MIKSZTAL, ANDREW; MALEFYT, THOMAS; LEE, KATHLEEN M
To: ROCHE PALO ALTO LLC
Reel/Frame 047498/0945 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2016
From: ROCHE PALO ALTO LLC
To: HELSINN HEALTHCARE SA
Reel/Frame 038544/0269 →
Continuity (6)
Division 13901437 · May 23, 2013
Continuation In Part 13087012 · Apr 14, 2011
Continuation 11186311 · Jul 21, 2005
Continuation PCTEP2004000888 · Jan 30, 2004
Provisional Application 60444351 · Jan 30, 2003
Related Publication 20140097114A1 · Apr 10, 2014