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Generated: January 20, 2019

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
Applicant:Bausch And Lomb Inc
Ingredient:bepotastine besilate
Generic Entry Opportunity Date for 022288
Generic Entry Date for 022288*:
Constraining patent/regulatory exclusivity:

*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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Serving hundreds of leading biopharmaceutical companies globally:

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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 verifification 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.