Details for New Drug Application (NDA): 208945
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NDA 208945 describes XEPI, which is a drug marketed by Ferrer Internacional and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XEPI profile page.
The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ozenoxacin profile page.
The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ozenoxacin profile page.
Summary for 208945
| Tradename: | XEPI |
| Applicant: | Ferrer Internacional |
| Ingredient: | ozenoxacin |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208945
Generic Entry Date for 208945*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*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: 208945
Suppliers and Packaging for NDA: 208945
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XEPI | ozenoxacin | CREAM;TOPICAL | 208945 | NDA | Biofrontera Inc. | 70621-103 | 70621-103-03 | 1 TUBE in 1 CELLO PACK (70621-103-03) / 3 g in 1 TUBE |
| XEPI | ozenoxacin | CREAM;TOPICAL | 208945 | NDA | Biofrontera Inc. | 70621-103 | 70621-103-10 | 1 TUBE in 1 BOX (70621-103-10) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Dec 11, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 11, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 9, 2023 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 29, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES | ||||||||
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