Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Boehringer Ingelheim
Harvard Business School
Medtronic
Johnson and Johnson

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022212

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 022212 describes DUREZOL, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. 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 four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the difluprednate profile page.
Summary for 022212
Tradename:DUREZOL
Applicant:Novartis
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
Paragraph IV (Patent) Challenges for 022212
Tradename Dosage Ingredient NDA Submissiondate
DUREZOL EMULSION;OPHTHALMIC difluprednate 022212 2014-05-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.05%
Approval Date:Jun 23, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 13, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jun 13, 2019
Regulatory Exclusivity Use:TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
Patent:  Start TrialPatent Expiration:Nov 18, 2019Product 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:

Mallinckrodt
Colorcon
McKinsey
Merck
Express Scripts
Johnson and Johnson

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.