IP Library › Granted Patent US 12,466,882
Granted Patent B2
US 12,466,882 · App. 17/673,149 · Granted Nov 11, 2025

Pharmaceutical formulations for adalimumab

Inventors: Gudrun Bachmann (Reykjavik, IS); Elin Edwald (Reykjavik, IS)
Assignee: ALVOTECH HF
C07K16/241A61K47/02A61K47/10A61K47/26
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Quick Facts
Patent No.
US 12,466,882
App. No.
17/673,149
Granted
Nov 11, 2025
Kind
B2
Abstract

A pharmaceutical composition comprises a buffer-less aqueous formulation of adalimumab, a salt, a polyol, and a polysorbate. The formulation is suitable for injection.

Claims (25)

1 . A pharmaceutical composition, comprising:

pharmaceutical-grade water having dissolved and/or suspended therein:

(a) 90-110 mg/ml of adalimumab;

(b) 5 mM to 25 mM of a chloride salt;

(c) 180 mM to 300 mM of a polyol; and

(d) 0.1% (w/v) of a polysorbate;

wherein said composition is buffer-less.

2 . The pharmaceutical composition according to claim 1 , wherein said salt is NaCl.

3 . The pharmaceutical composition according to claim 1 , wherein said polyol is at least one selected from the group consisting of mannitol and sucrose.

4 . The pharmaceutical composition according to claim 3 , wherein said polyol is mannitol and said polyol concentration is between 220 mM and 240 mM.

5 . The pharmaceutical composition according to claim 3 , wherein said polyol is sucrose and said polyol concentration is between 240 mM and 270 mM.

6 . The pharmaceutical composition according to claim 1 , wherein said polysorbate is polysorbate 80 or polysorbate 20.

7 . The pharmaceutical composition according to claim 1 , wherein said salt concentration is from 10 mM to 20 mM.

8 . The pharmaceutical composition according to claim 6 , wherein said salt is NaCl, said salt concentration is 10 mM, said polyol is mannitol, and said polyol concentration is 230 mM.

9 . The pharmaceutical composition according to claim 6 , wherein said salt is NaCl, said salt concentration is 10 mM, said polyol is sucrose, and said polyol concentration is 255 mM.

10 . The pharmaceutical composition according to claim 1 , wherein said composition has an osmolality within the range of 300 to 400 mOsm/kg.

11 . The pharmaceutical composition according to claim 1 , wherein said composition has a pH between 4.9 and 5.5.

12 . The pharmaceutical composition according to claim 1 , wherein said salt is at least one selected from the group consisting of MgCl 2 , KCl, NaCl, and CaCl 2 .

13 . The pharmaceutical composition according to claim 12 , wherein said salt concentration is from 10 mM to 20 mM.

14 . The pharmaceutical composition according to claim 13 , wherein said salt is NaCl.

15 . The pharmaceutical composition according to claim 10 , wherein said composition has an osmolality within the range of 330 to 380 mOsm/kg.

16 . The pharmaceutical composition according to claim 11 , wherein said composition has a pH of 5.2±0.2.

17 . The pharmaceutical composition according to claim 8 , wherein said polysorbate is polysorbate 80.

18 . The pharmaceutical composition according to claim 17 , wherein said composition has a pH of 5.2±0.2.

19 . The pharmaceutical composition according to claim 9 , wherein said polysorbate is polysorbate 80.

Assignments (4)
SUPER-PRIORITY TERM LOAN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jan 12, 2026
From: ALVOTECH HF
To: GLAS AMERICAS LLC, AS COLLATERAL AGENT
Reel/Frame 074320/0378 →
RELEASE OF SECURITY INTEREST Recorded Aug 19, 2024
From: MADISON PACIFIC TRUST LIMITED
To: ALVOTECH; ALVOTECH HF.; ALVOTECH HANNOVER GMBH; ALVOTECH GERMANY GMBH; ALVOTECH SWISS AG
Reel/Frame 068325/0797 →
TERM LOAN INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Aug 15, 2024
From: ALVOTECH HF
To: GLAS AMERICAS LLC, AS COLLATERAL AGENT
Reel/Frame 068630/0214 →
SECURITY INTEREST Recorded Jan 12, 2023
From: ALVOTECH, AS ISSUER AND CHARGOR; ALVOTECH HF., AS CHARGOR; ALVOTECH HANNOVER GMBH, FKA GLYCOTHERA GMBH, AS CHARGOR; ALVOTECH GERMANY GMBH, FKA BALIOPHARM GMBH, AS CHARGOR; ALVOTECH SWISS AG, AS CHARGOR
To: MADISON PACIFIC TRUST LIMITED, AS AGENT AND SECURITY TRUSTEE
Reel/Frame 062381/0052 →
Continuity (3)
Continuation 16646864
Provisional Application 62560889 · Sep 20, 2017
Related Publication 20220169716A1 · Jun 2, 2022
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