BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
US Army

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022212

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NDA 022212 describes DUREZOL, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the DUREZOL profile page.

The generic ingredient in DUREZOL is difluprednate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
Summary for 022212
Applicant:Novartis Pharms Corp
Suppliers and Packaging for NDA: 022212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUREZOL difluprednate EMULSION;OPHTHALMIC 022212 NDA Alcon Laboratories, Inc. 0065-9240 0065-9240-07 1 BOTTLE in 1 CARTON (0065-9240-07) > 5 mL in 1 BOTTLE
DUREZOL difluprednate EMULSION;OPHTHALMIC 022212 NDA Alcon Laboratories, Inc. 0065-9240 0065-9240-08 1 BOTTLE in 1 CARTON (0065-9240-08) > 1 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Jun 23, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 13, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 13, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 22, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Harvard Business School
Fish and Richardson

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