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Last Updated: December 22, 2024

Claims for Patent: 6,294,548

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Summary for Patent: 6,294,548

Title:	Multidose vial formulations for administering endo-N-(9-methyl-9-azabicyclo[3.3. 1]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride
Abstract:	Invented are improved multidose aqueous formulations of endo-N-(9-methyl-9-azabicyclo[3.3.1. ]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride.
Inventor(s):	James; Susan (Haverhill, GB)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	09/548,838
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,294,548
Patent Claims:	1. A multidose aqueous formulation comprising endo-N-(9-methyl-9-azabicyclo[3.3. 1]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride and as a preservative, benzyl alcohol. 2. A multidose aqueous formulation as disclosed in claim 1, further comprising citric acid. 3. A multidose aqueous formulation as disclosed in claim 1 wherein benzyl alcohol is present in an amount from about 0.85% to about 1.15% w/w. 4. A multidose aqueous formulation as disclosed in claim 2 wherein benzyl alcohol is present in an amount from about 0.85% to about 1.15% w/w and citric acid, as citric acid monohydrate, is present in an amount from about 0.15% to about 0.25% w/w. 5. A multidose aqueous formulation as disclosed in claim 3 wherein benzyl alcohol is present in an amount of about 1.0% w/w. 6. A multidose aqueous formulation as disclosed in claim 4 wherein benzyl alcohol is present in an amount of about 1.0% w/w and citric acid, as citric acid monohydrate, is present in an amount of about 0.2% w/w. 7. A 4 mL multidose aqueous formulation as disclosed in claim 4 wherein each 1 mL contains 1.12 mg endo-N-(9-methyl-9-azabicyclo[3.3. 1]non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride, and wherein benzyl alcohol is present in an amount from about 0.85% to about 1.15% w/w and citric acid, as citric acid monohydrate, is present in an amount from 0.15% to 0.25% w/w. 8. A multidose aqueous formulation as disclosed in claim 7 wherein benzyl alcohol is present in an amount of about 10 mg and citric acid is present in an amount of about 2 mg. 9. A multidose aqueous formulation as disclosed in claim 7 wherein the product is stable with regards to bacteria, mold and yeast contamination for a period of at least 35 days from the first aliquot extraction. 10. A multidose aqueous formulation as disclosed in claim 8 wherein the product is stable with regards to bacteria, mold and yeast contamination for a period of at least 35 days from the first aliquot extraction.

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