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Last Updated: March 28, 2024

Claims for Patent: 8,772,315


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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.

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