Adalimumab patent expiry?

What is the current Adalimumab patent situation?

Adalimumab, a widely used immunosuppressive treatment primarily for rheumatoid arthritis, is marketed under the brand name Humira. As of [1], the patent for the originator Humira was set to expire in the United States in 2023. However, due to complex patent law and litigation, the situation is more nuanced.

Who has the patent, and what's their timeline?

The original patent for Adalimumab was assigned to Abbott Laboratories and later acquired by AbbVie. According to [2], AbbVie's US patent (US 6,879,783) for Humira expired in June 2023. However, the company has secured additional patents for various modifications and improvements to the original formulation.

Are there generic versions of Adalimumab?

Despite the patent expirations, AbbVie continues to fight against generic versions of Adalimumab with multiple lawsuits and patent challenges. However, [3] DrugPatentWatch.com indicates that several generic manufacturers have secured FDA approval, awaiting the expiration of the remaining patents.

What about biosimilars and competition?

Several biosimilars, often less expensive alternatives to the originator product, are already available internationally. However, their US entry has been delayed by AbbVie's ongoing legal battles. Some biosimilars like [4] Samsung Bioepis' Imraldi, may still be available in certain scenarios.

What happens next?

As AbbVie's remaining patents expire and the FDA approves more generic Adalimumab products, competition in the market for this treatment is expected to intensify, potentially leading to reduced prices and increased accessibility.

References:

[1] AbbVie's Humira patent expiration date
[2] AbbVie US patent US 6,879,783
[3] DrugPatentWatch.com - Adalimumab patent expiry
[4] Samsung Bioepis Imraldi biosimilar