Gemtesa is a drug owned by Urovant Sciences Gmbh. It is protected by 4 US drug patents filed from 2021 to 2025 out of which none have expired yet. Gemtesa's patents have been open to challenges since 23 December, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 22, 2040. Details of Gemtesa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US12180219 | Process for preparing beta 3 agonists and intermediates |
Mar, 2034
(8 years from now) | Active |
| US8247415 | Hydroxymethyl pyrrolidines as β3 adrenergic receptor agonists |
Dec, 2030
(5 years from now) | Active |
| US8653260 | Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists |
Apr, 2029
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12102638 | Use of vibegron to treat overactive bladder |
Mar, 2040
(14 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gemtesa's patents.
Latest Legal Activities on Gemtesa's Patents
Given below is the list of recent legal activities going on the following patents of Gemtesa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8247415 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8653260 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Feb, 2024 | US8247415 |
| Second letter to regulating agency to determine regulatory review period | 06 Feb, 2023 | US8247415 |
| Second letter to regulating agency to determine regulatory review period | 06 Feb, 2023 | US8653260 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2023 | US8247415 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2023 | US8653260 |
| Initial letter Re: PTE Application to regulating agency | 30 Nov, 2021 | US8247415 |
| Initial letter Re: PTE Application to regulating agency | 30 Nov, 2021 | US8653260 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jul, 2021 | US8653260 |
FDA has granted several exclusivities to Gemtesa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gemtesa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gemtesa.
Exclusivity Information
Gemtesa holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Gemtesa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 23, 2025 |
| New Indication(I-955) | Dec 18, 2027 |
US patents provide insights into the exclusivity only within the United States, but Gemtesa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gemtesa's family patents as well as insights into ongoing legal events on those patents.
Gemtesa's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Gemtesa:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Gemtesa(Vibegron) has 3 clinical trials that have been verified in 2024.
Generic Launch
Generic Release Date:
Gemtesa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 22, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gemtesa Generics:
There are no approved generic versions for Gemtesa as of now.
About Gemtesa
Gemtesa is a drug owned by Urovant Sciences Gmbh. It is used for treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Gemtesa uses Vibegron as an active ingredient. Gemtesa was launched by Urovant in 2020.
Approval Date:
Gemtesa was approved by FDA for market use on 23 December, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Gemtesa is 23 December, 2020, its NCE-1 date is estimated to be 23 December, 2024.
Active Ingredient:
Gemtesa uses Vibegron as the active ingredient. Check out other Drugs and Companies using Vibegron ingredient
Treatment:
Gemtesa is used for treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Dosage:
Gemtesa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 75MG | TABLET | Prescription | ORAL |