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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
QuintilesIMS
Chinese Patent Office
Cantor Fitzgerald
Moodys
McKinsey
Harvard Business School
Fish and Richardson
Cerilliant

Generated: January 22, 2018

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Claims for Patent: 9,125,905

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Summary for Patent: 9,125,905
Title:Liquid pharmaceutical formulations of palonosetron
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.
Inventor(s): Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, IT), Cannella; Roberta (Varese, IT), Macciocchi; Alberto (Melide, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA)
Assignee: Helsinn Healthcare SA (Lugano/Pazzallo, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:14/597,489
Patent Claims: 1. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises palonosetron or a pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base.

2. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of from 4 to 6.

3. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 5.0.+-.0.5.

4. A method of manufacturing a finished container of a pharmaceutical formulation comprising palonosetron or a pharmaceutically acceptable salt thereof, said method comprising: a) providing an open container; b) filling said container with an aqueous intravenous solution comprising said palonosetron or pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base; c) sealing said filled container; and d) terminally sterilizing said sealed, filled container to obtain said finished container.

5. The method of claim 4, wherein said aqueous intravenous solution has a pH of from 4 to 6.

6. The method of claim 4, wherein said aqueous intravenous solution has a pH of 5.0.+-.0.5.

7. A finished container of palonosetron or a pharmaceutically acceptable salt thereof, manufactured and terminally sterilized by the process of claim 4.

8. The finished container of claim 7, wherein said aqueous intravenous solution has a pH of from 4 to 6.

9. The finished container of claim 7, wherein said aqueous intravenous solution has a pH of 5.0.+-.0.5.

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
UBS
Federal Trade Commission
Teva
Argus Health
Covington
Daiichi Sankyo
Baxter

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