Details for New Drug Application (NDA): 213006
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NDA 213006 describes GEMTESA, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the GEMTESA profile page.
The generic ingredient in GEMTESA is vibegron. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vibegron profile page.
The generic ingredient in GEMTESA is vibegron. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vibegron profile page.
Summary for 213006
| Tradename: | GEMTESA |
| Applicant: | Sumitomo Pharma Am |
| Ingredient: | vibegron |
| Patents: | 5 |
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 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH) | ||||||||
| Patent: | 12,102,638 | 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: | 12,180,219 | Patent Expiration: | Mar 12, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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