Bromfenac sodium - Generic Drug Details

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What are the generic drug sources for bromfenac sodium and what is the scope of patent protection?

Bromfenac sodium is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Alembic Pharms Ltd, Amring Pharms, Apotex, Coastal Pharms, Gland Pharma Ltd, Hi Tech, Mylan, Vistapharm, Sun Pharma Global, and Bausch And Lomb, and is included in twelve NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bromfenac sodium has thirty patent family members in fourteen countries.

Five suppliers are listed for this compound.

Summary for bromfenac sodium

International Patents:	30
US Patents:	10
Tradenames:	5
Applicants:	11
NDAs:	12
Suppliers / Packagers:	5
Bulk Api Vendors:	68
Clinical Trials:	5
Patent Applications:	24
Drug Prices:	Drug price trends for bromfenac sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bromfenac sodium
DailyMed Link:	bromfenac sodium at DailyMed

See drug prices for bromfenac sodium

Recent Clinical Trials for bromfenac sodium

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

Sponsor	Phase
Ministry of Health, China	N/A
Sun Yat-sen University	N/A
Federal University of São Paulo	Phase 4

See all bromfenac sodium clinical trials

Pharmacology for bromfenac sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for BROMFENAC SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
BROMSITE	SOLUTION/DROPS;OPHTHALMIC	bromfenac sodium	206911	2017-10-25
PROLENSA	SOLUTION/DROPS;OPHTHALMIC	bromfenac sodium	203168	2013-07-26

US Patents and Regulatory Information for bromfenac sodium

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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	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Alembic Pharms Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560-001	Jun 21, 2019	AT2	RX	No	No	Start Trial	Start Trial				Start Trial
Gland Pharma Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	211029-001	Mar 17, 2020	AT2	RX	No	No	Start Trial	Start Trial				Start Trial
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	202435-001	Jun 19, 2014		DISCN	No	No	Start Trial	Start Trial				Start Trial
Hi Tech	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203395-001	Jan 22, 2014	AT2	RX	No	Yes	Start Trial	Start Trial				Start Trial
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
>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 bromfenac sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for bromfenac sodium

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Country	Patent Number	Estimated Expiration
Hong Kong	1083468	Start Trial
Austria	393627	Start Trial
Mexico	2014004347	Start Trial
Canada	2944832	Start Trial
Japan	WO2004064828	Start Trial
China	1700913	Start Trial
Portugal	2403493	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for bromfenac sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	11C0031	France	Start Trial	PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C 2011 004	Romania	Start Trial	PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316	SPC/GB11/054	United Kingdom	Start Trial	PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1586316	132011901975261	Italy	Start Trial	PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	2011C/027	Belgium	Start Trial	PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	C300494	Netherlands	Start Trial	PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	1190018-0	Sweden	Start Trial	RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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