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Serving 500+ biopharmaceutical companies globally:

Merck
Covington
McKinsey
Citi
UBS
Colorcon
Accenture
US Army
Healthtrust
Express Scripts

Generated: September 21, 2017

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 NDA: 022212

Tradename:
1
Applicant:
1
Ingredient:
1
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

Summary 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 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Dow
Cipla
Daiichi Sankyo
Teva
UBS
US Department of Justice
Boehringer Ingelheim
Mallinckrodt

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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