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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022288

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NDA 022288 describes BEPREVE, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BEPREVE profile page.

The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bepotastine besilate profile page.
Summary for 022288
Tradename:BEPREVE
Applicant:Bausch And Lomb Inc
Ingredient:bepotastine besilate
Patents:3
Generic Entry Opportunity Date for 022288
Generic Entry Date for 022288*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022288
Suppliers and Packaging for NDA: 022288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288 NDA Bausch & Lomb Incorporated 24208-629 24208-629-01 1 BOTTLE, DROPPER in 1 CARTON (24208-629-01) > 10 mL in 1 BOTTLE, DROPPER
BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288 NDA Bausch & Lomb Incorporated 24208-629 24208-629-02 1 BOTTLE, DROPPER in 1 CARTON (24208-629-02) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1.5%
Approval Date:Sep 8, 2009TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Sep 5, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 30, 2023Product Flag?YSubstance Flag?Delist Request?

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