Claims for Patent: 9,187,559

Summary for Patent: 9,187,559

Title:	Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease
Abstract:	Multiple-variable dose methods for treating TNF.alpha.-related disorders, including Crohn\'s disease and psoriasis, comprising administering TNF.alpha. inhibitors, including TNF.alpha. antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.
Inventor(s):	Hoffman; Rebecca S. (Wilmette, IL), Chartash; Elliot K. (Randolph, NJ), Taylor; Lori K. (Wadsworth, IL), Granneman; George R. (Lindenhurst, IL), Yan; Philip (Vernon Hills, IL)
Assignee:	AbbVie Biotechnology Ltd (Hamilton, BM)
Application Number:	14/628,068
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,187,559
Patent Claims:	1. A multiple-variable dose method for treating idiopathic inflammatory bowel disease in a human subject in need thereof, comprising subcutaneously administering to the human subject: a first dose of 160 mg of adalimumab administered to the human subject within a day; and a second dose of 80 mg of adalimumab administered to the human subject within a day, wherein the second dose is administered two weeks following administration of the first dose. 2. The method of claim 1, wherein the method further comprises administering to the human subject a subsequent subcutaneous injection of 40 mg of adalimumab two weeks following administration of the second dose. 3. The method of claim 2, wherein the method further comprises administering to the human subject additional subsequent subcutaneous injections of 40 mg of adalimumab, wherein the subsequent subcutaneous injections are administered two weeks apart. 4. A multiple-variable dose method for treating idiopathic inflammatory bowel disease in a human subject in need thereof, comprising subcutaneously administering to the human subject: a first dose of 160 mg of adalimumab administered as a set of four injections of 40 mg of adalimumab administered to the human subject within a day; and a second dose of 80 mg of adalimumab administered as a set of two injections of 40 mg of adalimumab administered to the human subject within a day, wherein the second dose is administered two weeks following administration of the first dose. 5. The method of claim 4, wherein the method further comprises administering to the human subject a subsequent subcutaneous injection of 40 mg of adalimumab two weeks following administration of the second dose. 6. The method of claim 5, wherein the method further comprises administering to the human subject additional subsequent subcutaneous injections of 40 mg of adalimumab, wherein the subsequent subcutaneous injections are administered two weeks apart. 7. The method of claim 4, wherein each subcutaneous injection is administered to the human subject using a prefilled syringe. 8. The method of claim 5, wherein each subcutaneous injection is administered to the human subject using a prefilled syringe. 9. The method of claim 1, wherein the human subject has Crohn's disease. 10. The method of claim 1, wherein the human subject has ulcerative colitis. 11. The method of claim 4, wherein the human subject has Crohn's disease. 12. The method of claim 4, wherein the human subject has ulcerative colitis. 13. The method of claim 9, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 14. The method of claim 11, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 15. The method of claim 2, wherein the human subject has Crohn's disease. 16. The method of claim 15, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 17. The method of claim 2, wherein the human subject has ulcerative colitis. 18. The method of claim 3, wherein the human subject has Crohn's disease. 19. The method of claim 18, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 20. The method of claim 3, wherein the human subject has ulcerative colitis. 21. The method of claim 1, wherein each subcutaneous administration is with a prefilled syringe. 22. The method of claim 2, wherein each subcutaneous injection is administered to the human subject using a prefilled syringe. 23. The method of claim 3, wherein each subcutaneous injection is administered to the human subject using a prefilled syringe. 24. The method of claim 5, wherein the human subject has Crohn's disease. 25. The method of claim 24, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 26. The method of claim 5, wherein the human subject has ulcerative colitis. 27. The method of claim 6, wherein the human subject has Crohn's disease. 28. The method of claim 27, wherein the human subject achieves a Crohn's Disease Activity Index (CDAI) score of <150. 29. The method of claim 6, wherein the human subject has ulcerative colitis. 30. The method of claim 6, wherein each subcutaneous injection is administered to the human subject using a prefilled syringe.

Details for Patent 9,187,559

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2021-03-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2021-03-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2021-03-07