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Last Updated: April 25, 2024

Claims for Patent: 9,321,846

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Summary for Patent: 9,321,846

Title:	Compositions and methods comprising binding proteins for adalimumab
Abstract:	Compositions and methods comprising proteins that bind specifically to adalimumab are disclosed herein. Adalimumab is a monoclonal antibody specific for the cytokine TNF-.alpha. and was developed to treat TNF-.alpha. mediated inflammatory diseases. In one aspect of the instant invention, the binding proteins are antibodies directed toward adalimumab. These antibodies, including binding fragments thereof, can be used in a clinical setting as well as for research and development. For example, these anti-adalimumab antibodies can be employed to neutralize adalimumab.
Inventor(s):	Kaymakcalan; Zehra (Westborough, MA), Xiong; Limin (Shrewsbury, MA)
Assignee:	ABBVIE BIOTECHNOLOGY LTD. (Hamilton, BM)
Application Number:	14/630,322
Patent Claims:	1. An isolated monoclonal antibody, or an antigen binding portion thereof, which specifically binds adalimumab and comprises the amino acid sequences of all the complementarity determining regions (CDRs) of antibody 5A1-2A8, produced by a hybridoma having ATCC accession number PTA-8513. 2. The antibody, or the antigen binding portion thereof, of claim 1, wherein said antibody, or antigen binding portion thereof, binds to adalimumab with a dissociation equilibrium constant (K.sub.D) ranging from about 10.sup.-6 M to about 10.sup.-12 M. 3. A pharmaceutical composition comprising the antibody, or the antigen binding portion thereof, of claim 1 and a pharmaceutically acceptable carrier. 4. The composition of claim 3 further comprising a therapeutic agent. 5. The composition of claim 4, wherein said agent is another antibody. 6. An immunoconjugate comprising said antibody, or the antigen binding portion thereof, of claim 1 and a therapeutic agent. 7. A pharmaceutical composition comprising said immunoconjugate of claim 6 and a pharmaceutically acceptable carrier. 8. A method of detecting adalimumab in a sample, comprising contacting said sample with the antibody, or antigen-binding portion thereof, of claim 1 under conditions suitable for antibody-antigen complex formation, followed by detecting presence or amount of said complex formation as indicative of the presence or amount of adalimumab in the sample. 9. The method of claim 8, wherein said detecting is accomplished with an assay selected from the group consisting of an EIA (enzyme immunoassay), an ELISA (enzyme linked immunosorbent assay), an RIA (radioimmunoassay), an indirect competitive immunoassay, a direct competitive immunoassay, a non-competitive immunoassay, a sandwich immunoassay, and an agglutination assay. 10. A kit comprising the antibody, or antigen binding portion thereof, of claim 1, and a reagent for detecting binding of the adalimumab antibody, or the antigen binding portion thereof, to adalimumab. 11. An isolated monoclonal antibody, or an antigen binding portion thereof, which specifically binds adalimumab and comprises the amino acid sequences of all the complementarity determining regions (CDRs) of antibody 1H11-2E10, produced by a hybridoma having ATCC accession number PTA-8512. 12. A pharmaceutical composition comprising the antibody, or the antigen binding portion thereof, of claim 11 and a pharmaceutically acceptable carrier. 13. A method of detecting adalimumab in a sample, comprising contacting said sample with the antibody, or antigen-binding portion thereof, of claim 11 under conditions suitable for antibody-antigen complex formation, followed by detecting presence or amount of said complex formation as indicative of the presence or amount of adalimumab in the sample. 14. A kit comprising the antibody, or antigen binding portion thereof, of claim 11, and a reagent for detecting binding of the antibody, or antigen binding portion thereof, to adalimumab.

Details for Patent 9,321,846

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2027-08-28
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2027-08-28
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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