BEPREVE Drug Patent Profile

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 are two patents 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. Three 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.

Summary for BEPREVE

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	7
Patent Applications:	189
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

See drug prices 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 two US patents.

Patents protecting BEPREVE

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			Y
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	AT	RX	Yes	Yes			Y

Expired US Patents for BEPREVE

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

International Patents for BEPREVE

When does loss-of-exclusivity occur for BEPREVE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

China

European Patent Office

Japan

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	118016	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE COMPOUND AND PROCESS FOR PREPARING THE SAME
Japan	2012180360	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE, AND METHOD FOR PRODUCING THE SAME
Japan	2014169294	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE AND MANUFACTURING METHOD THEREOF
Austria	528003
Japan	2000159763	OPTICAL RESOLUTION OF PIPERIDINE DERIVATIVE USING ACYLAMINO ACID