Details for New Drug Application (NDA): 213006
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The generic ingredient in GEMTESA is vibegron. One supplier is listed for this compound. Additional details are available on the vibegron profile page.
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 Action | Adrenergic 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: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Dec 23, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 23, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 22, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 1, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY |
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