IP Library › Granted Patent US 10,159,732
Granted Patent B2
US 10,159,732 · App. 15/726,165 · Granted Dec 25, 2018

Stable aqueous formulations of adalimumab

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Quick Facts
Patent No.
US 10,159,732
App. No.
15/726,165
Granted
Dec 25, 2018
Kind
B2
Abstract

The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Claims (17)

1. A stable aqueous pharmaceutical composition comprising:

i) adalimumab;

ii) a buffer; and

iii) a stabilizer;

wherein the composition is free of mannitol and has a pH of about 5 to about 6.

2. The composition of claim 1 , wherein the composition is free of citrate buffer.

3. The composition of claim 1 , wherein the composition further comprises a surfactant.

4. The composition of claim 1 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

5. The composition of claim 1 , wherein the composition is free of sodium chloride.

6. The composition of claim 5 , wherein the composition further comprises a surfactant.

7. The composition of claim 6 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

8. A stable aqueous pharmaceutical composition comprising adalimumab and a citrate-free buffer, wherein the composition is free of mannitol and has a pH of about 5 to about 6.

9. The composition of claim 8 , wherein the composition further comprises a surfactant.

10. The composition of claim 8 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

11. The composition of claim 8 , wherein the composition is free of sodium chloride.

12. The composition of claim 11 , wherein the composition further comprises a surfactant.

13. The composition of claim 12 , wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

Assignments (6)
TERMINATION AND RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY AT REEL/FRAME NO. 59436/0055 Recorded May 9, 2024
From: BIOPHARMA CREDIT PLC, AS COLLATERAL AGENT
To: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
Reel/Frame 067378/0256 →
SECURITY INTEREST Recorded May 8, 2024
From: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.; SURFACE ONCOLOGY, LLC; COHERUS ONCOLOGY SUPPORTIVE CARE LLC
To: ANKURA TRUST COMPANY, LLC
Reel/Frame 067348/0160 →
SECURITY INTEREST Recorded Mar 18, 2022
From: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 059436/0055 →
RELEASE OF NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS AT REEL/FRAME NO. 048021/0975 Recorded Jan 11, 2022
From: HCR COLLATERAL MANAGEMENT, LLC
To: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
Reel/Frame 058692/0665 →
SECURITY INTEREST Recorded Jan 7, 2019
From: COHERUS BIOSCIENCES, INC.; COHERUS INTERMEDIATE CORP.; INTEKRIN THERAPEUTICS INC.
To: HCR COLLATERAL MANAGEMENT, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 048021/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2018
From: MANNING, MARK; PAYNE, ROBERT W.
To: COHERUS BIOSCIENCES, INC.
Reel/Frame 047386/0687 →
Cited By (1)
US 12,247,071