The primary patent for Tremfya (guselkumab) is set to expire in September 2034 [1]. This expiration date pertains to U.S. Patent No. 9,597,412 [1].
What are Tremfya's other patent protections?
Beyond the primary patent, Tremfya benefits from a portfolio of other patents covering various aspects of its development and use. These include patents related to its manufacturing process, specific formulations, and methods of treatment [2]. For instance, U.S. Patent No. 10,729,476, concerning a method of treating psoriasis, is also listed as expiring in 2034 [1]. Other patents are set to expire later, with some extending into 2037 and 2039 [2].
Can biosimilars be approved before the main patent expires?
While the main patent expiration in 2034 provides a clear timeline for potential generic competition, the regulatory pathway for biosimilars, particularly for complex biologic drugs like Tremfya, can be intricate [3]. Biosimilar manufacturers may seek to challenge existing patents to gain earlier market entry [4]. The process involves demonstrating that their product is highly similar to the reference biologic with no clinically meaningful differences [3].
Who is developing Tremfya?
Tremfya is developed and marketed by Janssen Biotech, a subsidiary of Johnson & Johnson [5].
What is Tremfya used for?
Tremfya is an interleukin-23 (IL-23) inhibitor approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy [6]. It is also indicated for adults with active psoriatic arthritis [7].
How does Tremfya work?
Tremfya targets the p19 subunit of IL-23, a cytokine that plays a role in inflammatory processes [6]. By inhibiting IL-23, Tremfya helps to reduce inflammation and the symptoms associated with psoriasis and psoriatic arthritis [6][7].
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Sources:
1. DrugPatentWatch.com. (n.d.). Tremfya. Retrieved from https://drugpatentwatch.com/drugs/tremfya
2. DrugPatentWatch.com. (n.d.). Guselkumab Patents. Retrieved from https://drugpatentwatch.com/drugs/tremfya/patents
3. Food and Drug Administration. (n.d.). Biosimilar Basics. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-basics
4. DrugPatentWatch.com. (n.d.). Patent Litigation. Retrieved from https://drugpatentwatch.com/ (General information on patent litigation)
5. Janssen Biotech, Inc. (n.d.). TREMFYA® (guselkumab) Prescribing Information. Retrieved from https://www.janssenlabels.com/tremfya/prescribing-information.pdf
6. U.S. Food and Drug Administration. (n.d.). FDA Approves Tremfya (guselkumab) For Adults With Moderate To Severe Plaque Psoriasis. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremfya-guselkumab-adults-moderate-severe-plaque-psoriasis
7. U.S. Food and Drug Administration. (n.d.). FDA Approves Tremfya (guselkumab) For Adults With Active Psoriatic Arthritis. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-tremfya-guselkumab-adults-active-psoriatic-arthritis