Skyrizi patent expiration?

When Does the Skyrizi Patent Expire?

Skyrizi, a medication used to treat moderate to severe plaque psoriasis, was first approved by the U.S. Food and Drug Administration (FDA) in 2018 [1]. The medication's patent is held by Abvie, Inc. (AbbVie) and is currently set to expire on December 19, 2057, according to records on DrugPatentWatch.com, a database that tracks pharmaceutical patents [2].

Why Is the Patent Expiration of Skyrizi Important?

The expiration of the Skyrizi patent will enable generic or biosimilar versions of the medication to enter the market, potentially increasing competition and reducing prices. Generic and biosimilar versions of medications often enter the market after the original patent expires, resulting in lower prices for consumers due to savings from reduced research and development costs, marketing, and other expenses.

What Side Effects Are Patients Concerned About?

Skyrizi, a monoclonal antibody medication, can cause side effects such as injection-site reactions (like redness and swelling), headache, and fatigue, according to the medication's prescribing information. Patients are encouraged to discuss potential side effects with their healthcare providers before starting treatment [3].

Will Biosimilars Enter the Market Before the Patent Expiration?

While the patent for Skyrizi is set to expire in 2057, biosimilar manufacturers may begin seeking FDA approval for their versions before the patent expires. Biosimilar approval is typically granted through the 351(k) pathway, which allows the FDA to approve a biosimilar without requiring full human clinical pharmacology and safety studies.

How Does This Impact the Skyrizi Medication Price?

The introduction of generic or biosimilar medications may lead to price competition, enabling patients to access the medication at a lower cost. However, Abvie, Inc. may continue to sell Skyrizi during the patent expiration transition, and the price may remain high until the generic versions enter the market.

Sources:

[1] U.S. Food and Drug Administration. (2018). Skyrizi Approval Letter.

[2] DrugPatentWatch.com. (n.d.). Skyrizi Patent Expiration.

[3] U.S. Food and Drug Administration. (n.d.). Skyrizi Package Insert.