Details for New Drug Application (NDA): 203168

✉ Email this page to a colleague

NDA 203168 describes PROLENSA, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from three suppliers. 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. Thirteen 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 Action	Cyclooxygenase 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	24208-602-04	1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.07% ACID
Approval Date:	Apr 5, 2013	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 19, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 11, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jan 16, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203168

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.