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

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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020816

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NDA 020816 describes AZOPT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the AZOPT profile page.

The generic ingredient in AZOPT is brinzolamide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brinzolamide profile page.
Summary for 020816
Tradename:AZOPT
Applicant:Novartis
Ingredient:brinzolamide
Patents:0
Pharmacology for NDA: 020816
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 020816
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816 NDA Alcon Laboratories, Inc. 0065-0275 0065-0275-10 1 BOTTLE, PLASTIC in 1 CARTON (0065-0275-10) > 10 mL in 1 BOTTLE, PLASTIC
AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816 NDA Alcon Laboratories, Inc. 0065-0275 0065-0275-15 1 BOTTLE, PLASTIC in 1 CARTON (0065-0275-15) > 15 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength1%
Approval Date:Apr 1, 1998TE:RLD:Yes

Expired US Patents for NDA 020816

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998   Start Trial   Start Trial
Novartis AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998   Start Trial   Start Trial
Novartis AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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