Claims for Patent: RE39941

Summary for Patent: RE39941

Title:	Amelioration of Dupuytren\'s disease
Abstract:	The cords of Dupuytren\'s disease are injected with collagenase, the hand is immediately immobilized and maintained immobile for several hours. The cord becomes relaxed or ruptured, relieving the hand contracture of the disease.
Inventor(s):	Wegman; Thomas L. (N. Merrick, NY)
Assignee:	Advance Biofactures Corporation (Lynbrook, NY)
Application Number:	11/094,753
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE39941
Patent Claims:	1. A method of treating an individual suffering from Dupuytren's disease which comprises injecting collagenase into a fibrous Dupuytren's cord in a hand of the individual suffering from the disease, immobilizing the hand immediately after injection, and maintaining the hand immobile for several hours, the amount and concentration of the collagenase being effective to relax or rupture the cord whereby the finger flexure caused by the cord is ameliorated. 2. A method according to claim 1 wherein a total amount of collagenase of at least 8,000 ABC units is injected in a pharmaceutically acceptable carrier in a concentration of at least about 30,000 ABC units per ml. 3. A method according to claim 2 wherein the total amount of collagenase is at least 10,000 ABC units and the concentration is at least about 40,000 ABC units per ml. 4. A method according to claim 1 wherein the collagenase is injected in a pharmaceutically acceptable carrier and the total volume of liquid injected does not exceed about 0.5 ml. 5. A method according to claim 4 wherein the total volume of liquid injected is in the range of 0.25 to 0.1 ml. 6. A method according to claim 1 wherein the injection is effected at multiple points in close proximity. 7. A method according to claim 6 wherein the injections are made at least three points in close proximity. 8. A method according to claim 1 wherein the individual is in the residual stage of Dupuytren's disease. 9. A method according to claim 1 wherein the hand is maintained immobile for a period of from 4 to 10 hours. 10. A method according to claim 1 wherein the injections are made at or near the metacarpophalangeal joint and/or the proximal interphalangeal joint. 11. A method according to claim 1 wherein the depth of the Dupuytren's cord in the hand is quantified by ultrasound scanning prior to injecting the collagenase. 12. A method according to claim 1 wherein the collagenase is in a pharmaceutically acceptable aqueous carrier. 13. A method of treating an individual suffering from Dupuytren's disease which comprises injecting into a fibrous Dupuytren's cord in a hand of the individual suffering from the disease an effective total amount of at least 8,000 ABC units of collagenase .Iadd.and wherein the collagenase is applied in a pharmaceutically acceptable carrier in a concentration of 20,000 to 50,000 ABC units collagenase per ml of carrier.Iaddend.. 14. A method according to claim 13 wherein the individual is in the residual stage of Dupuytren's disease. 15. A method according to claim 13 wherein the total amount of collagenase is within a range of 8,000 to about 15,000 ABC units. .[.16. A method according to claim 13 wherein the collagenase is applied in a pharmaceutically acceptable carrier in a concentration of about 15,000 to about 75,000 ABC units collagenase per ml of carrier..]. 17. A method according to claim 13 wherein the collagenase is injected in a pharmaceutically acceptable carrier and the total volume of liquid injected does not exceed about 0.5 ml. 18. A method according to claim 17 wherein the total volume of liquid injected is in the range of about 0.25 to 0.1 ml. 19. A method according to claim 13 wherein the injections are made at acute angles to the cord. 20. A method according to claim 13 wherein the collagenase is in a pharmaceutically acceptable aqueous carrier. .Iadd.21. A method according to claim 13 wherein the total amount of collagenase is at least 10,000 ABC units. .Iaddend. .Iadd.22. A method according to claim 13 wherein the total amount of collagenase is at least 10,000 ABC units and the concentration is at least about 40,000 ABC units per ml. .Iaddend. .Iadd.23. A method of treating an individual suffering from Duputyren's disease which comprises injecting collagenase into a fibrous Duputyren's cord in a hand of the individual suffering from the disease wherein a total amount of collagenase of at least 5,000 ABC units is injected in a pharmaceutically acceptable carrier in a concentration of between 20,000 to 50,000 ABC units per ml and the total volume of liquid injected does not exceed about 0.5 ml. .Iaddend. .Iadd.24. A method according to claim 23 wherein the total volume of liquid injected is in the range of 0.25 to 0.1 ml. .Iaddend. .Iadd.25. A method according to claim 23 wherein the collagenase is administered at multiple sites of the cord. .Iaddend. .Iadd.26. A method according to claim 25 wherein the injections are made at least three points in close proximity. .Iaddend. .Iadd.27. A method according to claim 23 wherein the total amount of collagenase is at least 8,000 ABC units and the concentration is at least about 30,000 ABC units per ml. .Iaddend. .Iadd.28. A method according to claim 23 wherein the hand is maintained immobile for a period of from 4 to 10 hours. .Iaddend. .Iadd.29. A method according to claim 23 wherein the injections are made at or near the metacarpophalangeal joint and/or the proximal interphalangeal joint. .Iaddend. .Iadd.30. A method according to claim 23 wherein the depth of the Dupuytren's cord in the hand is quantified by ultrasound scanning prior to injecting the collagenase. .Iaddend. .Iadd.31. A method according to claim 23 wherein the injections are made at acute angles to the cord. .Iaddend. .Iadd.32. A method of treating an individual suffering from Duputyren's disease which comprises injecting an effective amount of collagenase into a fibrous Duputyren's cord in a hand of the individual suffering from the disease wherein the collagenase is applied in a pharmaceutically acceptable carrier in a concentration of 20,000 to 50,000 ABC units collagenase per ml of carrier and the total volume of liquid injected does not exceed about 0.5 ml. .Iaddend. .Iadd.33. A method according to claim 32 wherein the total volume of liquid injected is in the range of about 0.25 to 0.1 ml. .Iaddend. .Iadd.34. A method according to claim 32 wherein the injections are made at acute angles to the cord. .Iaddend. .Iadd.35. A method according to claim 32 wherein the collagenase is administered at multiple sites of the cord. .Iaddend. .Iadd.36. A method according to claim 35 wherein the injections are made at least three points in close proximity. .Iaddend. .Iadd.37. A method according to claim 32 wherein the individual is in the residual stage of Dupuytren's disease. .Iaddend. .Iadd.38. A method according to claim 32 wherein the total amount of collagenase is within a range of 8,000 to about 15,000 ABC units. .Iaddend. .Iadd.39. A method according to claim 32 wherein the hand is maintained immobile for a period of from 4 to 10 hours. .Iaddend. .Iadd.40. A method according to claim 32 wherein the injections are made at or near the metacarpophalangeal joint and/or the proximal interphalangeal joint. .Iaddend. .Iadd.41. A method according to claim 32 wherein the depth of the Dupuytren's cord in the hand is quantified by ultrasound scanning prior to injecting the collagenase. .Iaddend. .Iadd.42. A method according to claim 32 wherein the injections are made at acute angles to the cord. .Iaddend. .Iadd.43. A method according to claim 32 wherein the individual is in the residual stage of Dupuytren's disease. .Iaddend.

Details for Patent RE39941

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965		2039-02-26
Auxilium Pharmaceuticals, Inc.	XIAFLEX	collagenase clostridium histolyticum	For Injection	125338	February 02, 2010		2039-02-26

International Patent Family for US Patent RE39941

Country	Patent Number	Estimated Expiration
Australia	5966198
Australia	733208
Germany	19813748
Denmark	177324
Denmark	40398
France	11C0033