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Last Updated: March 28, 2024

Claims for Patent: 10,080,788


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Summary for Patent: 10,080,788
Title:C1-INH compositions and methods for the prevention and treatment of disorders associated with C1 esterase inhibitor deficiency
Abstract: Compositions and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency are disclosed.
Inventor(s): Ruddy; Stephen (Exton, PA), Manning; Mark Cornell (Johnstown, CO), Holcomb; Ryan Erik (Fort Collins, CO)
Assignee: Shire ViroPharma Incorporated (Lexington, MA)
Application Number:15/837,677
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,080,788
Patent Claims:1. A method for prophylactic treatment of hereditary angioedema (HAE) comprising subcutaneously administering to a subject in need thereof a pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of about 500 U/mL, and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1, and wherein the administration of the composition increases the level of the C1 esterase inhibitor in the blood of the subject to at least about 0.4 U/mL.

2. The method of claim 1, wherein the pharmaceutical composition is reconstituted with water from at least one lyophilized powder comprising at least about 2000 U C1 esterase inhibitor and less than about 5000 U C1 esterase inhibitor.

3. The method of claim 1, wherein the C1 esterase inhibitor is administered in a range of about 1500 U to about 2500 U.

4. The method of claim 1, wherein at least about 2000 U of C1 esterase inhibitor is administered.

5. The method of claim 1, wherein the C1 esterase inhibitor is administered at a dose of about 5000 U.

6. The method of claim 1, wherein the C1 esterase inhibitor is administered in doses of at least about 2000 U and less than about 5000 U.

7. The method of claim 1, wherein the composition is administered daily, every other day, or every three days.

8. The method of claim 1, wherein the composition is administered one, two, or three times a week.

9. The method of claim 1, wherein the composition is administered three or more times per week.

10. The method of claim 1, wherein administration of the composition increases the level of functional C1 esterase inhibitor in the blood of the subject to or above 0.4 U/mL.

11. The method of claim 1, wherein administration of the composition maintains the level of functional C1 esterase inhibitor in the blood of the subject at or above 0.4 U/mL for at least 50% of the time between administrations.

12. The method of claim 1, wherein administration of the composition maintains the level of functional C1 esterase inhibitor in the blood of the subject at or above 0.4 U/mL for at least 75% of the time between administrations.

13. The method of claim 1, wherein administration of the composition maintains the level of functional C1 esterase inhibitor in the blood of the subject at or above 0.4 U/mL for at least 90% of the time between administrations.

14. The method of claim 1, wherein administration of the composition maintains the level of functional C1 esterase inhibitor in the blood of the subject at or above 0.4 U/mL for at least 95% of the time between administrations.

15. The method of claim 1, wherein the functional C1 esterase inhibitor blood levels are maintained above 0.4 U/mL for at least 95% of the time between administrations.

16. The method of claim 1, wherein the functional C1 esterase inhibitor blood levels are maintained above 0.4 U/mL for 100% of the time between administrations.

17. The method of claim 1, wherein the method of treating HAE consists of subcutaneously administering said composition.

18. The method of claim 1, wherein the method of prophylactic treatment consists of one or more subcutaneous administrations of said composition.

19. The method of claim 1, wherein administration of the composition does not comprise an initial intravenously administered dose of C1 esterase inhibitor.

20. The method of claim 1, wherein administration of the composition results in at least a reduction in the severity and/or number of HAE attacks.

21. The method of claim 1, wherein the composition is reconstituted from a lyophilized powder prior to administration.

22. The method of claim 21, wherein the lyophilized powder is reconstituted with sterile water.

23. The method of claim 1, wherein the composition is administered by the subject.

24. The method of claim 1, wherein the subject in need thereof is an adolescent human.

25. The method of claim 1, wherein the pH is between about 6.5 to about 7.5.

26. The method of claim 1, wherein the pH is between about 6.5 to about 7.0.

27. The method of claim 1, wherein the sodium citrate is present at about 10 mM to about 30 mM.

28. The method of claim 1, wherein the sodium citrate is present at 10 mM to 30 mM.

29. The method of claim 1, wherein the sodium citrate is present at about 10 mM.

30. The method of claim 1, wherein the pharmaceutical composition is a monoformulation of active pharmaceutical ingredient consisting essentially of C1 esterase inhibitor.

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