BEPREVE Drug Patent Profile

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When do Bepreve patents expire, and what generic alternatives are available?

Bepreve is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in eight countries.

The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bepreve

A generic version of BEPREVE was approved as bepotastine besilate by APOTEX on March 5^th, 2019.

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Summary for BEPREVE

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	7
Patent Applications:	138
Drug Prices:	Drug price information for BEPREVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEPREVE
What excipients (inactive ingredients) are in BEPREVE?	BEPREVE excipients list
DailyMed Link:	BEPREVE at DailyMed

Drug patent expirations by year for BEPREVE

Recent Clinical Trials for BEPREVE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Southern California College of Optometry	Phase 4
Southern California College of Optometry at Marshall B. Ketchum University	Phase 4
McCabe Vision Center	N/A

See all BEPREVE clinical trials

Pharmacology for BEPREVE

Drug Class	Histamine-1 Receptor Antagonist

Paragraph IV (Patent) Challenges for BEPREVE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEPREVE	Ophthalmic Solution	bepotastine besilate	1.5%	022288	3	2013-09-09

US Patents and Regulatory Information for BEPREVE

BEPREVE is protected by one US patents.

Patents protecting BEPREVE

Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BEPREVE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BEPREVE

See the table below for patents covering BEPREVE around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1022477		⤷ Sign Up
Japan	5518928		⤷ Sign Up
Taiwan	486475		⤷ Sign Up
Japan	2012180360	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE, AND METHOD FOR PRODUCING THE SAME	⤷ Sign Up
Australia	2003252746	AQUEOUS LIQUID PREPARATIONS AND LIGHT-STABILIZED AQUEOUS LIQUID PREPARATIONS	⤷ Sign Up
South Korea	101016595		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration