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Last Updated: April 24, 2024

Bromfenac sodium - Generic Drug Details

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What are the generic drug sources for bromfenac sodium and what is the scope of freedom to operate?

Bromfenac sodium is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Alembic, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, Sentiss, Sun Pharm, and Bausch And Lomb, and is included in sixteen 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.

Ten suppliers are listed for this compound.

Summary for bromfenac sodium

International Patents:	30
US Patents:	10
Tradenames:	5
Applicants:	13
NDAs:	16
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	6
Patent Applications:	492
Drug Prices:	Drug price trends for bromfenac sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bromfenac sodium
What excipients (inactive ingredients) are in bromfenac sodium?	bromfenac sodium excipients list
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
Seoul National University Hospital	Phase 2
Sun Yat-sen University	N/A
Ministry of Health, China	N/A

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	Strength	NDA	ANDAs Submitted	Submissiondate
BROMSITE	Ophthalmic Solution	bromfenac sodium	0.075%	206911	1	2017-10-25
PROLENSA	Ophthalmic Solution	bromfenac sodium	0.07%	203168	1	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	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Rising	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203368-001	Jun 3, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Coastal Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201211-001	May 11, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sentiss	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203395-001	Jan 22, 2014	AT2	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560-001	Jun 21, 2019	AT2	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Try a Trial	⤷ Try a 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	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010102192		⤷ Try a Trial
Mexico	2016014404	PREPARACION LIQUIDA ACUOSA QUE CONTIENE ACIDO 2-AMINO-3-(BROMOBENZOIL) FENILACETICO. (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)P HENYLACETIC ACID.)	⤷ Try a Trial
Germany	122011100019		⤷ Try a Trial
Austria	393627		⤷ Try a Trial
Germany	602004013420		⤷ Try a Trial
Hungary	S1100022		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for bromfenac sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	C 2011 004	Romania	⤷ Try a 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	11C0031	France	⤷ Try a Trial	PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	SPC/GB11/054	United Kingdom	⤷ Try a 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	C300494	Netherlands	⤷ Try a 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	122011100019	Germany	⤷ Try a Trial	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	2011C/027	Belgium	⤷ Try a Trial	PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.