Is there a generic version of Myrbetriq available?
No, there is no FDA-approved generic version of Myrbetriq (mirabegron) available in the U.S. as of now. Myrbetriq remains under patent protection, with the primary formulation patent (U.S. Patent 6,777,423) expiring in 2023, but key extended-release patents extend exclusivity until 2033.[1][2]
When does Myrbetriq's patent expire?
The main compound patent expired in 2023, but formulation patents for the extended-release tablets (covering strengths like 25 mg and 50 mg) run until January 2033. Pediatric exclusivity adds six months, pushing full market exclusivity to mid-2033. No generics can launch until these expire or are successfully challenged.[2][3]
Are there any generic approvals or ANDAs pending?
The FDA has not approved any abbreviated new drug applications (ANDAs) for generic mirabegron. Several companies, including Alembic, Apotex, and Lupin, have filed Paragraph IV challenges against Astellas' patents, triggering potential litigation. These could lead to earlier generic entry if challengers win, but no settlements or approvals have been announced.[1][2]
What are authorized generics or alternatives to Myrbetriq?
No authorized generics exist from Astellas. For overactive bladder (OAB), alternatives include generics of other drugs like oxybutynin (available since 2000), tolterodine (since 2007), or solifenacin (generic since 2020). Gemtesa (vibegron), a newer beta-3 agonist competitor, has no generic yet and costs similarly to Myrbetriq.[4]
How much does Myrbetriq cost without insurance?
A 30-day supply of brand-name Myrbetriq 50 mg tablets averages $500-$550 without insurance or discounts. Patient assistance programs from Astellas or coupons via GoodRx can reduce it to $20-$50 for eligible patients.[5]
[1]: FDA Orange Book for Myrbetriq
[2]: DrugPatentWatch.com - Myrbetriq Patents
[3]: FDA Patent Certifications
[4]: GoodRx - OAB Medications
[5]: GoodRx - Myrbetriq Pricing