Details for New Drug Application (NDA): 214900
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NDA 214900 describes BREXAFEMME, which is a drug marketed by Scynexis 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 BREXAFEMME profile page.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. One supplier is listed for this compound. Additional details are available on the ibrexafungerp citrate profile page.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. One supplier is listed for this compound. Additional details are available on the ibrexafungerp citrate profile page.
Summary for 214900
| Tradename: | BREXAFEMME |
| Applicant: | Scynexis |
| Ingredient: | ibrexafungerp citrate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214900
Generic Entry Date for 214900*:
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: 214900
| Mechanism of Action | Glucan Synthase Inhibitors |
Suppliers and Packaging for NDA: 214900
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900 | NDA | SCYNEXIS, INC. | 75788-115 | 75788-115-04 | 1 BLISTER PACK in 1 CARTON (75788-115-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jun 1, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 1, 2031 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Jun 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 30, 2025 | ||||||||
| Regulatory Exclusivity Use: | REDUCTION IN THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN ADULT AND POST-MENARCHAL PEDIATRIC FEMALES | ||||||||
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