How to Keep Humira Stable in a Liquid Medicine Bottle
A recipe for a stable, liquid version of the drug Humira that stays effective at high concentrations without spoiling or clumping.
Original patent title: “Formulation of human antibodies for treating TNF-α associated disorders”
A recipe for a stable, liquid version of the drug Humira that stays effective at high concentrations without spoiling or clumping. Granted to Abbott Biotech Ltd Bermuda in 2012 with 21 claims and 58 forward citations.
Key facts
Coverage
What does this patent actually cover?
This patent describes a specific chemical mixture that keeps a powerful antibody drug, known as D2E7 (Humira), stable in liquid form. Because antibodies are fragile proteins, they often clump together or break down when stored in water. The inventors created a precise buffer system using citrate and phosphate, combined with mannitol (a sugar alcohol) and polysorbate 80 (a surfactant), to protect the antibody at high concentrations. This allows the medicine to be injected easily without the need for the patient to mix a powder with liquid beforehand.
The gap
What does this patent NOT cover?
- Does not cover the antibody D2E7 itself, only this specific liquid formulation.
- Does not cover formulations that use different buffer systems, such as those using only acetate or histidine.
- Does not cover freeze-dried or solid powder versions of the medication.
- Does not cover antibody concentrations outside the specified 20-150 mg/ml range.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The inventors discovered that a specific combination of citrate and phosphate buffers, when paired with a surfactant like polysorbate 80, prevents the antibody from unfolding or sticking to the walls of the syringe, which was a major hurdle for high-concentration protein drugs.
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Humira (adalimumab) injection pens
Why it matters
The bigger picture
This formulation is the backbone of Humira, one of the best-selling drugs in history. By enabling a stable, ready-to-use liquid injection, it made the drug significantly easier for patients with conditions like rheumatoid arthritis to self-administer at home. It set a high bar for the pharmaceutical industry in how to stabilize complex protein-based therapies.
Filed
August 15, 2003
Granted
July 10, 2012
Market context
Who's building on this
Companies in this space
AbbVie, the company that spun off from Abbott, continues to manage the legacy of this formulation. Many biosimilar manufacturers have also had to navigate this patent landscape to develop their own versions of adalimumab that use different, non-infringing stabilization techniques.
Market impact
This patent helped secure the commercial dominance of Humira for nearly two decades. By protecting the specific liquid formulation, it created a significant barrier to entry for competitors, leading to extensive litigationlitigationA lawsuit over patent infringement. Litigated patents often signal commercial importance.Read more → and patent thickets as other companies attempted to bring biosimilar versions to market.
Claim 1 — Plain English
What this patent covers
This patent describes a specific chemical mixture that keeps a powerful antibody drug, known as D2E7 (Humira), stable in liquid form. Because antibodies are fragile proteins, they often clump together or break down when stored in water. The inventors created a precise buffer system using citrate and phosphate, combined with mannitol (a sugar alcohol) and polysorbate 80 (a surfactant), to protect the antibody at high concentrations. This allows the medicine to be injected easily without the need for the patient to mix a powder with liquid beforehand.
The clever bit
The inventors discovered that a specific combination of citrate and phosphate buffers, when paired with a surfactant like polysorbate 80, prevents the antibody from unfolding or sticking to the walls of the syringe, which was a major hurdle for high-concentration protein drugs.
What it does not cover
- Does not cover the antibody D2E7 itself, only this specific liquid formulation.
- Does not cover formulations that use different buffer systems, such as those using only acetate or histidine.
- Does not cover freeze-dried or solid powder versions of the medication.
- Does not cover antibody concentrations outside the specified 20-150 mg/ml range.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Moderate
Citation count
35/40
Highly cited
Claim breadth
14/20
Broad claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →
Recency
5/20
Granted 10–20 years ago
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$132K – $421K
Midpoint $263K · expired or expiring · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
The original legal language
Original claims
21 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Baust, L., Kruase, H., & Dickes, M. (2012). How to Keep Humira Stable in a Liquid Medicine Bottle (U.S. Patent No. 8,216,583). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/8216583/humira-dosing-regimen
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does How to Keep Humira Stable in a Liquid Medicine Bottle cover?
A recipe for a stable, liquid version of the drug Humira that stays effective at high concentrations without spoiling or clumping.
Who owns patent US 8216583?
Abbott Biotech Ltd Bermuda owns this patent, granted in 2012.
When does this patent expire?
This patent is expected to expire on July 10, 2032, when the invention enters the public domain.
What is patent US 8216583 cited by?
This patent has been cited by 58 later patents that build on its ideas.
What problem does this patent solve?
This formulation is the backbone of Humira, one of the best-selling drugs in history. By enabling a stable, ready-to-use liquid injection, it made the drug significantly easier for patients with conditions like rheumatoid arthritis to self-administer at home. It set a high bar for the pharmaceutical industry in how to stabilize complex protein-based therapies.
What does this patent NOT cover?
Does not cover the antibody D2E7 itself, only this specific liquid formulation.
Patent monitoring