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Details for New Drug Application (NDA): 203567
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NDA 203567 describes JUBLIA, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JUBLIA profile page.
The generic ingredient in JUBLIA is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.
The generic ingredient in JUBLIA is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.
Summary for 203567
| Tradename: | JUBLIA |
| Applicant: | Bausch |
| Ingredient: | efinaconazole |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 203567
Generic Entry Date for 203567*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 203567
Suppliers and Packaging for NDA: 203567
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567 | NDA | Bausch Health US LLC | 0187-5400 | 0187-5400-02 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) > 2 mL in 1 BOTTLE, WITH APPLICATOR |
| JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567 | NDA | Bausch Health US LLC | 0187-5400 | 0187-5400-04 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) > 4 mL in 1 BOTTLE, WITH APPLICATOR |
Paragraph IV (Patent) Challenges for 203567
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| JUBLIA | SOLUTION;TOPICAL | efinaconazole | 203567 | 2018-06-06 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 10% | ||||
| Approval Date: | Jun 6, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 27, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jul 8, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Oct 2, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES | ||||||||
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