Claims for Patent: 8,772,315

Summary for Patent: 8,772,315

Title:	Pharmaceutical composition for treating overactive bladder
Abstract:	A pharmaceutical composition comprising (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or a pharmaceutically acceptable salt thereof and (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof, as active ingredients, in particular for improving various symptoms accompanying overactive bladder, such as urinary urgency, pollakiuria and/or urinary incontinence.
Inventor(s):	Suzuki; Masanori (Chuo-ku, JP), Ukai; Masashi (Chuo-ku, JP), Ohtake; Akiyoshi (Chuo-ku, JP)
Assignee:	Astellas Pharma Inc. (Tokyo, JP)
Application Number:	13/748,956
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,772,315
Patent Claims:	1. A pharmaceutical composition, comprising: (i) (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or a pharmaceutically acceptable salt thereof present from 25 to 50 mg in terms of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide and (ii) (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof present at 5 mg in terms of (3R)-quinuclidin-3-yl (1S)-I-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate. 2. The pharmaceutical composition of claim 1, wherein the (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or a pharmaceutically acceptable salt thereof is (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide. 3. The pharmaceutical composition of claim 2, wherein the (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof is (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate. 4. The pharmaceutical composition of claim 1, wherein the (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof is (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate. 5. A method for treating urinary urgency, pollakiuria and/or urinary incontinence accompanying overactive bladder, comprising administering effective amounts of (i) (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or a pharmaceutically acceptable salt thereof at a dosage of 25 to 50 mg in terms of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide, and (ii) (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or a pharmaceutically acceptable salt thereof at a dosage of 5 mg in terms of (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate. 6. The method claim 5, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof, and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof are both administered orally. 7. The method for treating of claim 5, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof and said (3R)-quinuclidin-3-yl (1S)-I-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof are administered simultaneously. 8. The method of claim 7, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof, and said (3R)-quinuclidin-3-yl (1S)-I-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof are both administered orally. 9. The method of claim 5, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof and said (3R)-quinuclidin-3-yl (1S)-I-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof are administered at a time interval. 10. The method of claim 9, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof, and said (3R)-quinuclidin-3-yl (1S)-I-phenyl-I,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof are both administered orally. 11. The method of claim 5, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide or pharmaceutically acceptable salt thereof is (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide, and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate or pharmaceutically acceptable salt thereof is (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate. 12. The method of claim 11, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide, and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate are both administered orally. 13. The method of claim 11, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate are administered simultaneously. 14. The method of claim 13, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide, and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate are both administered orally. 15. The method of claim 11, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate are administered at a time interval. 16. The method of claim 15, wherein said (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl}a- cetanilide, and said (3R)-quinuclidin-3-yl (1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate succinate are both administered orally.