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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203168

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NDA 203168 describes PROLENSA, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PROLENSA profile page.

The generic ingredient in PROLENSA is bromfenac sodium. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 203168
Tradename:PROLENSA
Applicant:Bausch And Lomb
Ingredient:bromfenac sodium
Patents:9
Pharmacology for NDA: 203168
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 203168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168 NDA Bausch & Lomb Incorporated 24208-602 24208-602-03 1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) > 3 mL in 1 BOTTLE, DROPPER
PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168 NDA Bausch & Lomb Incorporated 24208-602 24208-602-06 1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) > .6 mL in 1 BOTTLE, DROPPER
Paragraph IV (Patent) Challenges for 203168
Tradename Dosage Ingredient NDA Submissiondate
PROLENSA SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 203168 2013-07-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.07% ACID
Approval Date:Apr 5, 2013TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 19, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jan 16, 2024Product Flag?YSubstance Flag?Delist Request?

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