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Last Updated: October 21, 2019

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Claims for Patent: 8,961,974

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Summary for Patent: 8,961,974
Title:Multiple-variable dose regimen for treating TNF.alpha.-related disorders
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 Keith (Randolph, NJ), Taylor; Lori K. (Wadsworth, IL), Granneman; George Richard (Lindenhurst, IL), Yan; Philip (Vernon Hills, IL)
Assignee: AbbVie Biotechnology Ltd. (Hamilton, BM)
Application Number:14/229,722
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,961,974
Patent Claims:1. A multiple-variable dose method for treating ulcerative colitis in a subject in need thereof, comprising subcutaneously administering to the subject: a first dose of 160 mg of a recombinant human anti-TNF.alpha. antibody administered to the subject within a day; and a second dose of 80 mg of the antibody administered to the subject within a day, wherein the second dose is administered two weeks following administration of the first dose; wherein the antibody comprises: a heavy chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:8; a CDR2 comprising the amino acid sequence of SEQ ID NO:6; and a CDR3 comprising the amino acid sequence of SEQ ID NO:4; and a light chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:7; a CDR2 comprising the amino acid sequence of SEQ ID NO:5; and a CDR3 comprising the amino acid sequence of SEQ ID NO:3.

2. The method of claim 1, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

3. The method of claim 2, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

4. The method of claim 3, wherein the antibody is adalimumab.

5. The method of claim 1, wherein the method further comprises administering to the subject a subsequent subcutaneous injection of 40 mg of the antibody two weeks following administration of the second dose.

6. The method of claim 5, wherein the method further comprises administering to the subject additional subsequent subcutaneous injections of 40 mg of the antibody, wherein the subsequent subcutaneous injections are administered two weeks apart.

7. The method of claim 5, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

8. The method of claim 6, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

9. The method of claim 7, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

10. The method of claim 8, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

11. The method of claim 9, wherein the antibody is adalimumab.

12. The method of claim 10, wherein the antibody is adalimumab.

13. The method of claim 1, wherein each subcutaneous injection is administered to the subject using a prefilled syringe.

14. The method of claim 5, wherein each subcutaneous injection is administered to the subject using a prefilled syringe.

15. A multiple-variable dose method for treating ulcerative colitis in a subject in need thereof, comprising subcutaneously administering to the subject: a first dose of 160 mg of a recombinant human anti-TNF.alpha. antibody administered as a set of four injections of 40 mg of the antibody administered to the subject within a day; and a second dose of 80 mg of the antibody administered as a set of two injections of 40 mg of the antibody administered to the subject within a day, wherein the second dose is administered two weeks following administration of the first dose; wherein the antibody comprises: a heavy chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:8; a CDR2 comprising the amino acid sequence of SEQ ID NO:6; and a CDR3 comprising the amino acid sequence of SEQ ID NO:4; and a light chain comprising a CDR1 comprising the amino acid sequence of SEQ ID NO:7; a CDR2 comprising the amino acid sequence of SEQ ID NO:5; and a CDR3 comprising the amino acid sequence of SEQ ID NO:3.

16. The method of claim 15, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

17. The method of claim 16, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

18. The method of claim 17, wherein the antibody is adalimumab.

19. The method of claim 15, wherein the method further comprises administering to the subject a subsequent subcutaneous injection of 40 mg of the antibody two weeks following administration of the second dose.

20. The method of claim 19, wherein the method further comprises administering to the subject additional subsequent subcutaneous injections of 40 mg of the antibody, wherein the subsequent subcutaneous injections are administered two weeks apart.

21. The method of claim 19, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

22. The method of claim 20, wherein the heavy chain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2, and the light chain comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:1.

23. The method of claim 21, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

24. The method of claim 22, wherein the heavy chain comprises an IgG1 heavy chain constant region and the light chain comprises a kappa light chain constant region.

25. The method of claim 23, wherein the antibody is adalimumab.

26. The method of claim 24, wherein the antibody is adalimumab.

27. The method of claim 15, wherein each subcutaneous injection is administered to the subject using a prefilled syringe.

28. The method of claim 19, wherein each subcutaneous injection is administered to the subject using a prefilled syringe.

Details for Patent 8,961,974

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial AbbVie Biotechnology Ltd. (Hamilton, BM) 2021-03-07 RX Orphan search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial AbbVie Biotechnology Ltd. (Hamilton, BM) 2021-03-07 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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