BEPOTASTINE BESILATE - Generic Drug Details

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What are the generic sources for bepotastine besilate and what is the scope of freedom to operate?

Bepotastine besilate is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Mylan, Somerset Theraps Llc, and Bausch And Lomb Inc, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bepotastine besilate has eleven patent family members in eight countries.

There are seven drug master file entries for bepotastine besilate. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BEPOTASTINE BESILATE

International Patents:	11
US Patents:	1
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	23
Patent Applications:	265
Drug Prices:	Drug price trends for BEPOTASTINE BESILATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEPOTASTINE BESILATE
What excipients (inactive ingredients) are in BEPOTASTINE BESILATE?	BEPOTASTINE BESILATE excipients list
DailyMed Link:	BEPOTASTINE BESILATE at DailyMed

See drug prices for BEPOTASTINE BESILATE

Recent Clinical Trials for BEPOTASTINE BESILATE

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

Sponsor	Phase
Laboratorios Poen	Phase 4
Laboratorios Sophia S.A de C.V.	Phase 1
Dong-A ST Co., Ltd.	N/A

See all BEPOTASTINE BESILATE clinical trials

Generic filers with tentative approvals for BEPOTASTINE BESILATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1.5%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BEPOTASTINE BESILATE

Drug Class	Histamine-1 Receptor Antagonist

Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE

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 BEPOTASTINE BESILATE

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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
Apotex	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	206066-001	Mar 5, 2019	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	206220-001	Mar 18, 2019	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	214588-001	Apr 5, 2023	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 BEPOTASTINE BESILATE

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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 BEPOTASTINE BESILATE

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Country	Patent Number	Title	Estimated Expiration
Japan	3631748		⤷ Sign Up
South Korea	101016595		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004011001		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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