Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203567

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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 nine 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.
Summary for 203567
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203567
Generic Entry Date for 203567*:
Constraining patent/regulatory exclusivity:

*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 Valeant Pharmaceuticals North America 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 Valeant Pharmaceuticals North America 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:RXDosage:SOLUTION;TOPICALStrength10%
Approval Date:Jun 6, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 6, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jul 8, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 5, 2021Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.