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BEPREVE Drug 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 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. Two suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.

DrugPatentWatch^® Generic Entry Outlook for Bepreve

Bepreve was eligible for patent challenges on September 8, 2013.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There is one tentative approval for the generic drug (bepotastine besilate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BEPREVE

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	5
Patent Applications:	15
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
McCabe Vision Center	N/A
Minnesota Eye Consultants, P.A.	Phase 4

See all BEPREVE clinical trials

Pharmacology for BEPREVE

Drug Class

Histamine-1 Receptor Antagonist

Paragraph IV (Patent) Challenges for BEPREVE

Tradename	Dosage	Ingredient	NDA	Submissiondate
BEPREVE	SOLUTION/DROPS;OPHTHALMIC	bepotastine besilate	022288	2013-09-09

US Patents and Regulatory Information for 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		RX	Yes	Yes			Y
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009		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

Country	Patent Number	Estimated Expiration
Malaysia	118016
Japan	3157117
Japan	3107784
Japan	2016006059
Austria	528003
Portugal	949260