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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213006


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NDA 213006 describes GEMTESA, which is a drug marketed by Urovant and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the GEMTESA profile page.

The generic ingredient in GEMTESA is vibegron. One supplier is listed for this compound. Additional details are available on the vibegron profile page.
Summary for 213006
Tradename:GEMTESA
Applicant:Urovant
Ingredient:vibegron
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213006
Generic Entry Date for 213006*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 213006
Mechanism of ActionAdrenergic beta3-Agonists
Suppliers and Packaging for NDA: 213006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMTESA vibegron TABLET;ORAL 213006 NDA Sumitomo Pharma America, Inc. 73336-075 73336-075-07 1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLE
GEMTESA vibegron TABLET;ORAL 213006 NDA Sumitomo Pharma America, Inc. 73336-075 73336-075-30 30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Dec 23, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 23, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Mar 22, 2040Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
Patent:⤷  Sign UpPatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.