Gemtesa Patent Expiration

Gemtesa is a drug owned by Urovant Sciences Gmbh. It is protected by 2 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2030. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8653260 Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Apr, 2029

(4 years from now)

Active
US8247415 Hydroxymethyl pyrrolidines as β3 adrenergic receptor agonists
Dec, 2030

(6 years from now)

Active


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 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. 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

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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

Gemtesa has patent protection in a total of 40 countries. It's US patent count contributes only to 14.8% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Gemtesa.

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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 Dec 01, 2030 (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.

Market Authorisation Date:

Gemtesa was approved by FDA for market use on 23 December, 2020.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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