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Last Updated: September 21, 2021

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Claims for Patent: 8,859,610


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Summary for Patent: 8,859,610
Title:Crystalline glycopyrrolate tosylate
Abstract: Salts of glycopyrrolate, including solid forms thereof are herein disclosed. Methods of making glycopyrrolate salts and methods of treating hyperhidrosis with salts of glycopyrrolate are disclosed.
Inventor(s): Statler; John Allan (Redwood City, CA), Shaw; Anthony Adrian (North Vancouver, CA), Imbert; Delphine Caroline (Cupertino, CA), Nelson; Jennifer Leigh (Kokomo, IN), Andres; Patricia (West Lafayette, IN), McQueen; Lisa Lynn (West Lafayette, IN), Boerrigter; Stephan Xander Mattheus (West Lafayette, IN)
Assignee: Dermira, Inc. (Redwood City, CA)
Application Number:14/024,484
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,859,610
Patent Claims: 1. An absorbant pad comprising a pharmaceutically acceptable solution comprising a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate or a solvate thereof and one or more pharmaceutically acceptable additives.

2. A pharmaceutically acceptable solution comprising a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate or a solvate thereof and one or more pharmaceutically acceptable additives for topical administration.

3. A method of treating hyperhidrosis comprising topically administering a therapeutically effective amount of a pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate or solvate thereof to the skin of a mammal.

4. The method of claim 3, wherein said mammal is human.

5. The method of claim 4, wherein said solution is applied to the axilla.

6. The method of claim 4, wherein said solution is applied to the hands.

7. The method of claim 4, wherein said solution is applied to the feet.

8. The method of claim 4, wherein said solution is applied to the groin, face, back, or abdomen.

9. The method of claim 3, where the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

10. The method of claim 4, where the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

11. The method of claim 5, where the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

12. The method of claim 6, wherein the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

13. The method of claim 7, wherein the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

14. The method of claim 8, wherein the administration is with an absorbent pad comprising an absorbed pharmaceutically acceptable solution of a racemic mixture of (R)-3-((S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate and (S)-3-((R)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidi- nium 4-methylbenzenesulfonate.

15. The solution of claim 1, wherein one pharmaceutically acceptable additive is ethanol.

16. The solution of claim 2, wherein one pharmaceutically acceptable additive is ethanol.

17. The solution of claim 3, wherein one pharmaceutically acceptable additive is ethanol.

18. The solution of claim 4, wherein one pharmaceutically acceptable additive is ethanol.

19. The solution of claim 5, wherein one pharmaceutically acceptable additive is ethanol.

20. The solution of claim 6, wherein one pharmaceutically acceptable additive is ethanol.

21. The solution of claim 7, wherein one pharmaceutically acceptable additive is ethanol.

22. The solution of claim 8, wherein one pharmaceutically acceptable additive is ethanol.

23. The solution of claim 9, wherein one pharmaceutically acceptable additive is ethanol.

24. The solution of claim 10, wherein one pharmaceutically acceptable additive is ethanol.

25. The solution of claim 11, wherein one pharmaceutically acceptable additive is ethanol.

26. The solution of claim 12, wherein one pharmaceutically acceptable additive is ethanol.

27. The solution of claim 13, wherein one pharmaceutically acceptable additive is ethanol.

28. The solution of claim 14, wherein one pharmaceutically acceptable additive is ethanol.

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