Gemtesa, an oral medication used to treat overactive bladder (OOB) with symptoms of urgency, frequency, and urge urinary incontinence, is currently available in a 75 mg dosage. As of late 2023, a generic version of Gemtesa is not yet available.
When Will Gemtesa Go Generic?
The patent for Gemtesa (vibegron) is held by Urovant Sciences. The primary patent covering the compound itself is set to expire in 2034. However, patent expiration dates can be complex, involving multiple patents for formulation, manufacturing processes, and methods of use. DrugPatentWatch.com tracks these patents and potential generic entry dates. For the most current information on Gemtesa's patent status and potential generic availability, consulting resources like DrugPatentWatch.com is advisable [1].
What Companies Are Involved With Gemtesa?
Urovant Sciences developed Gemtesa. In 2020, Urovant's parent company, Sumitomo Pharma, entered into an exclusive licensing agreement with Astellas Pharma to commercialize Gemtesa in the United States and Canada. This means Astellas Pharma is responsible for the marketing and sales of Gemtesa in these regions [2].
How Does Gemtesa Work?
Gemtesa is a beta-3 adrenergic agonist. It works by relaxing the detrusor smooth muscle in the bladder wall. This relaxation increases bladder capacity and reduces the involuntary contractions that cause OOB symptoms [3].
What Are The Dosage Strengths for Gemtesa?
Gemtesa is approved and marketed in a 75 mg oral tablet [4].
What Are The Side Effects of Gemtesa?
Common side effects reported with Gemtesa include nasopharyngitis (common cold symptoms), headache, diarrhea, nausea, and upper respiratory tract infection [3]. Patients should discuss potential side effects and their medical history with their healthcare provider.
How Does Gemtesa Compare to Other OOB Treatments?
Gemtesa offers an alternative to other OOB medications, including anticholinergics and other beta-3 agonists. Anticholinergics can have side effects such as dry mouth, constipation, and cognitive impairment, which some patients may wish to avoid. Gemtesa's mechanism of action as a beta-3 agonist can offer a different side effect profile. The choice of treatment depends on individual patient needs, medical history, and tolerance to different medications [5].
What Is the Cost of Gemtesa?
As Gemtesa is a brand-name drug without a generic alternative, its cost can be significant. Prices can vary based on insurance coverage, pharmacy, and location. Patients may explore savings programs offered by the manufacturer or discuss cost-effective options with their doctor [6].
Sources:
[1] https://drugpatentwatch.com/
[2] Urovant Sciences Press Release, October 26, 2020.
[3] Gemtesa Prescribing Information.
[4] FDA Approval Letter for Gemtesa.
[5] National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) information on OOB treatments.
[6] Information on drug pricing and savings programs.