Details for New Drug Application (NDA): 215888
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NDA 215888 describes VIVJOA, which is a drug marketed by Mycovia Pharms 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 VIVJOA profile page.
The generic ingredient in VIVJOA is oteseconazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oteseconazole profile page.
The generic ingredient in VIVJOA is oteseconazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the oteseconazole profile page.
Summary for 215888
| Tradename: | VIVJOA |
| Applicant: | Mycovia Pharms |
| Ingredient: | oteseconazole |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215888
Generic Entry Date for 215888*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 215888
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors |
Suppliers and Packaging for NDA: 215888
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIVJOA | oteseconazole | CAPSULE;ORAL | 215888 | NDA | Mycovia Pharmaceuticals, Inc. | 74695-823 | 74695-823-18 | 1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 26, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 26, 2032 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Apr 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,414,751 | Patent Expiration: | Mar 17, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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