BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Citi
Queensland Health
Dow
Baxter
Fuji
Chubb
McKinsey
Express Scripts
Deloitte
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
Tradename:DUREZOL
Applicant:Novartis Pharms Corp
Ingredient:difluprednate
Patents:1
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:

Cerilliant
McKinsey
Dow
Colorcon
US Department of Justice
Cantor Fitzgerald
Harvard Business School
Baxter
Fish and Richardson

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.

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