Claims for Patent: 8,404,744

Summary for Patent: 8,404,744

Title:	Methods of treatment and pharmaceutical composition
Abstract:	The invention relates a pharmaceutical composition comprising a combination of (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and (ii) a NEP inhibitor or a pharmaceutically acceptable salt thereof and optionally a pharmaceutically acceptable carrier and to a method for the treatment or prevention of selected conditions or diseases.
Inventor(s):	Ksander; Gary M (Milford, NJ), Webb; Randy L (Flemington, NJ)
Assignee:	Novartis AG (Basel, CH)
Application Number:	13/328,769
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,404,744
Patent Claims:	1. A pharmaceutical composition comprising: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are administered in combination in a 1:1 ratio. 2. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester. 3. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is a pharmaceutically acceptable salt of N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester. 4. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid. 5. The pharmaceutical composition of claim 1 wherein (ii) said NEP inhibitor is a pharmaceutically acceptable salt of (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid. 6. A pharmaceutical composition comprising: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are present in a 1:1 ratio. 7. A pharmaceutical composition consisting of: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; (ii) the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2- R-methylbutanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein said (i) AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and said (ii) NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methylbu- tanoic acid ethyl ester or a pharmaceutically acceptable salt thereof, or (2R,4S)-5-biphenyl-4-yl-4(3-carboxy-propionyl amino)-2-methyl-pentanoic acid or a pharmaceutically acceptable salt thereof, are present in a 1:1 ratio. 8. The pharmaceutical composition of claim 3 wherein the pharmaceutically acceptable salt is selected from the group consisting of the sodium salt, the triethanolamine salt and the tris(hydroxymethyl)aminomethane salt. 9. The pharmaceutical composition of claim 5 wherein the pharmaceutically acceptable salt is selected from the group consisting of the sodium salt, the triethanolamine salt and the tris(hydroxymethyl)aminomethane salt. 10. The pharmaceutical composition of claim 1 in the form of a capsule or tablet.