See the DrugPatentWatch profile for stelara
The primary patent protecting Stelara (ustekinumab) is set to expire in the United States in September 2023, and in the European Union in October 2023 [1]. This expiration marks a significant point for potential generic competition for the widely used medication.
What does patent expiration mean for Stelara?
When a drug's main patent expires, it generally opens the door for other companies to develop and market biosimilar versions of the medication [2]. Biosimilars are highly similar to the original biologic drug and are approved by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on rigorous scientific evidence demonstrating no clinically meaningful differences in safety, purity, and potency [2][3]. The introduction of biosimilars can lead to increased competition and potentially lower prices for patients and healthcare systems [3].
Are there other patents on Stelara that could affect competition?
While the September 2023 and October 2023 dates refer to the expiration of the main compound patent for Stelara, there may be other patents related to its formulation, method of use, or manufacturing processes [1]. These secondary patents can sometimes extend market exclusivity beyond the primary patent's expiration, though their enforceability can be subject to legal challenges [4]. DrugPatentWatch.com tracks these complex patent landscapes, providing detailed information on patent status and potential litigation [1].
What is Stelara used for?
Stelara is a biologic medication used to treat several chronic inflammatory conditions. In the U.S., it is approved for adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for adults and children 12 years and older with active psoriatic arthritis [5]. It is also indicated for adults with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis [5].
Who manufactures Stelara?
Stelara is manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson [5].
How do biosimilars get approved?
The approval process for biosimilars is designed to ensure they are safe and effective. Regulatory bodies compare the proposed biosimilar to the reference biologic drug using analytical studies, animal studies, and clinical studies, including pharmacokinetic and pharmacodynamic studies, as well as immunogenicity assessments [3]. The goal is to confirm that there are no significant differences in how the biosimilar works or how it affects the body compared to the original drug [3].
What are the potential benefits of Stelara biosimilars?
The availability of biosimilars can offer several advantages. Increased competition can drive down costs, making treatments more affordable for patients and reducing the financial burden on healthcare providers and insurers [3]. This can also expand patient access to important therapies for chronic conditions [3].
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Sources
[1] DrugPatentWatch.com. (n.d.). Stelara Patent Expirations. https://drugpatentwatch.com/medications/stelara
[2] U.S. Food & Drug Administration. (n.d.). Biosimilar Product Information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
[3] European Medicines Agency. (n.d.). Biosimilar medicines. https://www.ema.europa.eu/en/medicines/biosimilar-medicines
[4] DrugPatentWatch.com. (n.d.). Understanding Drug Patents. https://drugpatentwatch.com/resources/drug-patents
[5] Janssen Biotech, Inc. (n.d.). STELARA® (ustekinumab) prescribing information. https://www.janssenlabels.com/stelara/prescribing-information.pdf