You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

Last Updated: August 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207589

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 207589 describes ENSTILAR, which is a drug marketed by Leo Pharma As 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 ENSTILAR profile page.

The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.
Summary for 207589
Applicant:Leo Pharma As
Ingredient:betamethasone dipropionate; calcipotriene
Pharmacology for NDA: 207589
Suppliers and Packaging for NDA: 207589
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589 NDA LEO Pharma Inc. 50222-302 50222-302-60 1 CAN in 1 CARTON (50222-302-60) > 60 g in 1 CAN
ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589 NDA LEO Pharma Inc. 50222-302 50222-302-66 2 CAN in 1 CARTON (50222-302-66) > 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.064%;0.005%
Approval Date:Oct 16, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 30, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 30, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Dec 10, 2031Product Flag?Substance Flag?Delist Request?Y

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

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 verification 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.