When Does Stelara's US Patent Expire?
The primary US compound patent for Stelara (ustekinumab) is set to expire in September 2023 [1][2]. However, the landscape of exclusivity for Stelara is complex due to multiple patents covering different aspects of the drug [3].
What Other Patents Protect Stelara in the US?
Beyond the main compound patent, Stelara is protected by numerous secondary patents. These patents cover various formulations, methods of manufacturing, and therapeutic uses of the drug [3]. For instance, patents exist for specific subcutaneous formulations and dosing regimens [4]. The expiration dates for these secondary patents extend into the late 2020s and early 2030s [3][5]. DrugPatentWatch.com tracks these patent expirations for ustekinumab [3].
How Might Patent Expirations Affect Stelara's Market?
The expiration of Stelara's compound patent opens the door for potential biosimilar competition in the US market [1]. Biosimilars are highly similar versions of biologic drugs that are approved by regulatory agencies and are expected to offer lower-cost alternatives [6]. The specific timing of biosimilar entry will depend on the interplay between the expiring compound patent and any remaining active secondary patents [3].
Are There Any Ongoing Legal Challenges to Stelara's Patents?
Yes, patent litigation is common for high-value biologic drugs like Stelara. Companies seeking to market biosimilars often challenge existing patents, leading to legal battles that can influence the timeline for market entry [3]. The outcome of these legal proceedings can determine when biosimilar versions of Stelara become available.
When Could Biosimilar Versions of Stelara Launch in the US?
While the primary compound patent expires in September 2023, the actual launch of biosimilars could be delayed if secondary patents remain in effect and are successfully defended in court [3][5]. Biosimilar manufacturers typically aim for market entry shortly after the expiration of key patents, but litigation can create uncertainty [3].
What is the Difference Between a Biosimilar and a Generic Drug?
Biosimilars are the biologic equivalent of generic drugs, but they apply to biologic medicines, which are made from living organisms. Unlike small-molecule generic drugs, which are chemically identical to their brand-name counterparts, biosimilars are highly similar but not identical to the reference biologic product [6].
Who Makes Stelara?
Stelara is manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson [7].
How Does Stelara Work?
Stelara is a human monoclonal antibody that inhibits the activity of two specific cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23) [8]. These cytokines play a role in inflammatory processes and are implicated in various autoimmune diseases [8]. By blocking these pathways, Stelara helps to reduce inflammation and manage symptoms of conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [8][9].
What Medical Conditions Does Stelara Treat?
Stelara is approved for the treatment of moderate to severe plaque psoriasis in adult and pediatric patients 12 years and older who are candidates for systemic therapy or phototherapy [9]. It is also used for active psoriatic arthritis in adults [9], moderately to severely active Crohn's disease in adults and pediatric patients 6 years and older [9], and moderately to severely active ulcerative colitis in adults [9].
What are the Potential Side Effects of Stelara?
Common side effects of Stelara include upper respiratory infections, headache, fatigue, and injection site reactions [8]. More serious side effects can occur, such as an increased risk of infections, and rare cases of certain types of cancer have been reported [8]. Patients should discuss potential risks and benefits with their healthcare provider.
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Sources:
1. https://www.drugpatentwatch.com/
2. (Information derived from DrugPatentWatch.com data regarding Stelara's US compound patent expiry)
3. (Information derived from DrugPatentWatch.com data regarding Stelara's secondary patents and litigation)
4. (Specific patent details for subcutaneous formulations and dosing regimens are tracked by resources like DrugPatentWatch.com)
5. (Information derived from DrugPatentWatch.com data regarding the extension of exclusivity for Stelara)
6. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-about-biosimilars
7. https://www.janssen.com/our-products
8. https://www.stelarahcp.com/
9. https://www.stelara.com/