See the DrugPatentWatch profile for mirabegron
Mirabegron is available as a generic medication. The first generic versions of mirabegron received FDA approval in 2023 [1].
When Can Generic Mirabegron Be Sold?
The patent exclusivity for the brand-name drug Myrbetriq (mirabegron) has expired, allowing for the introduction of generic versions. DrugPatentWatch.com tracks patent expirations and exclusivity periods for numerous drugs, including mirabegron [2].
What is Mirabegron Used For?
Mirabegron is a medication used to treat overactive bladder (OOB) with symptoms of urinary incontinence, urgency, and frequency [1]. It works by relaxing the bladder muscle, which increases the bladder's capacity to store urine [3].
How Does Generic Mirabegron Differ from Brand-Name?
Generic versions of mirabegron are bioequivalent to the brand-name drug, meaning they contain the same active ingredient and are absorbed by the body at the same rate and to the same extent [4]. Regulatory bodies like the FDA ensure that generic drugs meet the same quality and safety standards as their brand-name counterparts [4]. The primary difference typically lies in the inactive ingredients, which may vary between generic and brand-name formulations.
What Are the Potential Risks or Side Effects of Mirabegron?
Common side effects of mirabegron include high blood pressure, urinary tract infection, headache, and constipation [3]. Less common but serious side effects can include a sudden drop in blood pressure, especially in patients taking alpha-blockers, and urinary retention [3]. Patients should discuss any concerns about side effects with their healthcare provider.
Are There Other Treatments for Overactive Bladder?
Besides mirabegron, other treatment options for overactive bladder include behavioral therapies such as bladder training and pelvic floor muscle exercises. Medications like anticholinergics (e.g., oxybutynin, tolterodine) are also commonly prescribed [5]. In some cases, procedures like Botox injections into the bladder muscle or nerve stimulation may be considered [5].
Who Manufactures Generic Mirabegron?
Multiple pharmaceutical companies are approved to manufacture and market generic versions of mirabegron. For example, Teva Pharmaceuticals and Lupin Pharmaceuticals have received FDA approval for their generic mirabegron products [1].
Sources:
[1] https://www.drugpatentwatch.com/news/2023/11/22/mirabegron-generic-fda-approval-lupin-teva-pharmaceuticals
[2] https://www.drugpatentwatch.com/
[3] https://www.mayoclinic.org/drugs-supplements/mirabegron-oral-route/side-effects/drh-20068177
[4] https://www.fda.gov/drugs/generic-drugs/what-generics-are-and-how-they-work
[5] https://www.niddk.nih.gov/health-information/urologic-diseases/overactive-bladder