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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Harvard Business School

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207589

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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 two 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. One supplier is 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 207589
Ingredient-typeVitamin D
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
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 N 50222-302-66
ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589 NDA LEO Pharma Inc. 50222-302 N 50222-302-60

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:Oct 16, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 10, 2031Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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