See the DrugPatentWatch profile for Stelara
The generic name for Stelara is ustekinumab [1].
What is Ustekinumab used to treat?
Ustekinumab is a medication used to treat several autoimmune conditions. It is approved for adults and children 12 years and older with moderate to severe plaque psoriasis who have had an inadequate response or are intolerant to other systemic therapies [2]. It is also used for adults with active psoriatic arthritis, adults with moderate to severe Crohn's disease, and adults with moderate to severe ulcerative colitis [2].
How does Ustekinumab work?
Ustekinumab is a human monoclonal antibody that targets the p19 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23) [3]. These cytokines play a role in inflammatory pathways that contribute to the symptoms of psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [3]. By blocking IL-12 and IL-23, ustekinumab helps to reduce inflammation [3].
When does the patent for Stelara expire?
The primary patents for Stelara are set to expire in 2023 and 2024 [4]. However, patent litigation and potential extensions can affect the exact timeline for generic availability [4]. Information on patent expirations and related legal challenges can be found at DrugPatentWatch.com [4].
Are there biosimilars or generics of Stelara available?
As of late 2023, there are no FDA-approved ustekinumab biosimilars or generics available in the United States. The expiry of key patents in 2023 and 2024 opens the door for potential biosimilar and generic competition in the near future, pending regulatory approvals [4].
What are the potential risks of taking Ustekinumab?
Like other immunosuppressants, ustekinumab carries risks. It can increase the risk of serious infections, including serious bacterial, fungal, viral, and opportunistic infections [2]. There is also a potential risk of certain cancers, particularly skin cancers, and malignancies of the lymphoid system [2]. Patients should discuss their full medical history and any concerns about these risks with their healthcare provider before starting treatment [2].