Stelara, a medication for plaque psoriasis, psoriatic arthritis, and Crohn's disease, is expected to face loss of exclusivity in the United States in late 2023 [1][2]. This marks a significant point for generic competition to enter the market [2].
When does Stelara's patent protection end?
Stelara's primary U.S. patent is set to expire in September 2023 [1][3]. This expiration is a key driver for the anticipated loss of exclusivity [2].
What does loss of exclusivity mean for Stelara?
Loss of exclusivity, often referred to as "patent cliff," signifies the end of a drug's market exclusivity granted by patents [4]. Following this, generic versions of the drug can be manufactured and marketed, typically leading to a substantial decrease in price [4]. For Stelara, this means that other companies will be able to introduce their own versions of the medication [2].
What is the difference between Stelara and its generic versions?
Generic versions of Stelara will contain the same active ingredient, ustekinumab, and are expected to be therapeutically equivalent [4]. They will be bioequivalent, meaning they perform the same way as the branded drug in the body [4]. The primary difference will likely be in the brand name, inactive ingredients, and cost [4].
When can generic Stelara become available?
While the patent expiration is in September 2023, the actual availability of generic Stelara depends on regulatory approvals and any ongoing patent litigation [2][3]. Companies are actively seeking approval for generic ustekinumab, and the first generics could become available around the patent expiration date [3].
Who are the companies developing generic Stelara?
Several pharmaceutical companies have been developing generic versions of Stelara. For example, Amneal Pharmaceuticals and Teva Pharmaceuticals have been involved in the development and potential market entry of ustekinumab generics [3][5].
How will generic Stelara impact treatment costs?
The introduction of generic ustekinumab is expected to significantly lower the cost of treatment for Stelara [4]. This can increase patient access to the therapy and reduce the financial burden on healthcare systems [4].
Are there any patent challenges or litigation for Stelara?
Patent challenges and litigation are common surrounding significant drug patent expirations [3]. Companies often file Paragraph IV certifications to challenge existing patents, which can lead to legal battles and potentially earlier market entry for generics [3]. Information on specific ongoing litigation can be tracked through resources like DrugPatentWatch.com [3].
What are the approved uses for Stelara?
Stelara (ustekinumab) is approved for the treatment of moderate to severe plaque psoriasis in adult and adolescent patients who are candidates for phototherapy or systemic therapy [1]. It is also approved for active psoriatic arthritis in adults, and for moderately to severely active Crohn's disease and ulcerative colitis in adult patients [1].
Sources:
[1] https://www.janssen.com/us/our-products/stelara
[2] https://www.drugpatentwatch.com/blog/2023/02/06/biosimilar-and-generic-drug-competition-tracker-2023/
[3] https://www.drugpatentwatch.com/drug/ustekinumab
[4] https://www.fda.gov/drugs/generic-drugs/what-generic-drugs-are-and-how-they-work
[5] https://www.amneal.com/news-releases/press-release-details/2023/Amneal-Announces-First-Generic-Launch-of-Stelara-ustekinumab-Injection-2023/