When Does Stelara's Core Patent Expire?
Stelara, a medication used to treat conditions like plaque psoriasis, psoriatic arthritis, and Crohn's disease, faces patent expirations that could open the door for generic alternatives. The primary patent for Stelara (ustekinumab) is slated to expire in September 2023 [1].
What Happens After the Main Patent Expires?
Following the expiry of the core patent, the market for Stelara is expected to change. This usually paves the way for the introduction of biosimilar versions of the drug, which are highly similar to the original biologic medication and are approved by regulatory agencies based on evidence of similarity [2].
Are There Other Patents Protecting Stelara?
In addition to the primary patent, there can be secondary patents covering aspects like manufacturing processes, specific formulations, or methods of use. These secondary patents can sometimes extend market exclusivity beyond the expiration of the main patent [3]. Information regarding the specific landscape of Stelara's secondary patents and any ongoing litigation can be found on resources like DrugPatentWatch.com [1].
How Do Biosimilars Work?
Biosimilars are approved by regulatory bodies like the U.S. Food and Drug Administration (FDA) after demonstrating that they are highly similar to an already approved biologic, known as the reference product. They are not identical, but they are expected to have no clinically meaningful differences in terms of safety, purity, and potency [2].
What Are the Potential Cost Implications?
The introduction of biosimilar competition can often lead to reduced prices for biologic medications. Patients and healthcare systems may see cost savings as more treatment options become available [2].
Who Makes Stelara?
Stelara is manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson [1].