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Summary for Patent: 10,159,733
|Title:||Stable aqueous formulations of adalimumab|
|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.|
|Inventor(s):||Manning; Mark (Johnstown, CO), Payne; Robert W. (Fort Collins, CO)|
|Assignee:||Coherus Biosciences, Inc. (Redwood City, CA)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent 10,159,733|
|Patent Claims:||1. A stable aqueous pharmaceutical composition comprising: i) adalimumab; ii) a single buffer; iii) a surfactant; and iv) a sugar, 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 2, wherein the single buffer is acetate.
4. The composition of claim 1, wherein the surfactant is polysorbate 80.
5. The composition of claim 1, wherein the sugar is sucrose.
6. The composition of claim 5, wherein the single buffer is acetate and the surfactant is polysorbate 80.
7. The composition of claim 6, wherein the composition is free of sodium chloride.
8. 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.
9. The composition of claim 8, wherein the single buffer is acetate, the surfactant is polysorbate 80, and the sugar is sucrose.
|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||Coherus Biosciences, Inc. (Redwood City, CA)||2039-02-16||RX||search|
|Abbvie Inc||HUMIRA||adalimumab||VIAL||125057||002||2002-12-31||Start Trial||Coherus Biosciences, Inc. (Redwood City, CA)||2039-02-16||RX||search|
|>Applicant||>Tradename||>Biologic Ingredient||>Dosage Form||>BLA||>Number||>Approval Date||>Patent No.||>Assignee||>Estimated Patent Expiration||>Status||>Orphan||>Source|
|Country||Patent Number||Publication Date|
|World Intellectual Property Organization (WIPO)||0174143||Oct 11, 2001|
|World Intellectual Property Organization (WIPO)||2014039903||Jun 26, 2014|
|World Intellectual Property Organization (WIPO)||2014039903||Mar 13, 2014|
|Uruguay||35351||Aug 29, 2014|
|United States of America||10155039||Dec 18, 2018|
|United States of America||10159732||Dec 25, 2018|
|>Country||>Patent Number||>Publication Date|
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