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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022428

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NDA 022428 describes MOXEZA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOXEZA profile page.

The generic ingredient in MOXEZA is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 022428
Tradename:MOXEZA
Applicant:Novartis
Ingredient:moxifloxacin hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022428
Suppliers and Packaging for NDA: 022428
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428 NDA Alcon Laboratories, Inc. 0065-0006 0065-0006-03 3 mL in 1 BOTTLE (0065-0006-03)
Paragraph IV (Patent) Challenges for 022428
Tradename Dosage Ingredient NDA Submissiondate
MOXEZA SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 022428 2012-02-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Nov 19, 2010TE:AT2RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Mar 29, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 29, 2029Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022428

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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