# 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.

- **Patent:** US 8216583
- **Original title:** Formulation of human antibodies for treating TNF-α associated disorders
- **Owner:** Abbott Biotech Ltd Bermuda
- **Granted:** 2012
- **Status:** Public domain (expired)
- **Times cited:** 58
- **Field:** biotech, pharmaceutical

## What it does

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.

## 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.

## 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.

## Real-world examples

1. Humira (adalimumab) injection pens

## Why it matters

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.

## 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.

**Full plain-English explainer:** https://patentbrief.org/patent/us/8216583/humira-dosing-regimen

**Original patent:** https://patents.google.com/patent/US8216583

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_Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._