Mirabegron, marketed as Myrbetriq and Betanis, is expected to have its generic availability in 2026, contingent on the resolution of patent disputes [1].
When does Mirabegron exclusivity expire?
The primary patent protecting Mirabegron is set to expire in 2026. However, a secondary patent, which extends protection, is slated to expire in 2029 [1]. The earlier expiration date in 2026 is particularly relevant for generic manufacturers aiming to enter the market.
Why are companies challenging Mirabegron patents?
Generic drug manufacturers often challenge existing patents to gain early market entry. For Mirabegron, this involves scrutinizing the validity and scope of its patent protections, potentially leading to legal battles that can influence the timeline for generic versions [1]. DrugPatentWatch.com tracks these patent challenges and their implications for market exclusivity [1].
Can biosimilars enter before patent expiry?
Mirabegron is a small molecule drug, not a biologic. Therefore, the concept of biosimilars, which applies to biologic drugs, is not relevant in this context. Generic versions of Mirabegron are the relevant alternative, and their availability is directly tied to patent expiry and any associated litigation [1].
What is Mirabegron used for?
Mirabegron is used to treat overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency [2]. It works by relaxing the detrusor muscle of the bladder [2].
How does Mirabegron compare to other OAB treatments?
Mirabegron belongs to a class of drugs called beta-3 adrenergic agonists. Unlike anticholinergic medications, which are also commonly used for OAB, Mirabegron targets a different pathway in the bladder muscle, potentially offering an alternative for patients who do not respond well to or cannot tolerate anticholinergics [2].
What are the potential risks or side effects of Mirabegron?
Common side effects of Mirabegron include increased blood pressure, urinary tract infection, and headache [2]. Patients taking Mirabegron should have their blood pressure monitored regularly [2].
Who manufactures Mirabegron?
Mirabegron was originally developed by Astellas Pharma [2]. Generic versions will be manufactured by various pharmaceutical companies once patent exclusivity is no longer a barrier.
Sources:
1. https://drugpatentwatch.com/mirabegron/
2. https://www.drugs.com/mirabegron.html