Details for New Drug Application (NDA): 214900
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NDA 214900 describes BREXAFEMME, which is a drug marketed by Glaxosmithkline and is included in one NDA. There are five patents protecting this drug. Additional details are available on the BREXAFEMME profile page.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. There is one drug master file entry for this compound. Additional details are available on the ibrexafungerp citrate profile page.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. There is one drug master file entry for this compound. Additional details are available on the ibrexafungerp citrate profile page.
Summary for 214900
| Tradename: | BREXAFEMME |
| Applicant: | Glaxosmithkline |
| Ingredient: | ibrexafungerp citrate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214900
Generic Entry Date for 214900*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW 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.
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 | ||||||||
| Patent: | 10,174,074 | Patent Expiration: | Jan 19, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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