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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, Akorn, Alembic Pharms Ltd, Amring Pharms, Apotex, Coastal Pharms, Gland Pharma Ltd, 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
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	5
Patent Applications:	26
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
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

Anatomical Therapeutic Chemical (ATC) Classes for bromfenac sodium

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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			Y	Y
Coastal Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201211-001	May 11, 2011		DISCN	No	No
Vistapharm	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201941-001	Feb 10, 2015		DISCN	No	No
Akorn	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203395-001	Jan 22, 2014	AT2	RX	No	Yes
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013		RX	Yes	Yes			Y

Expired US Patents for bromfenac sodium

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

International Patents for bromfenac sodium

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004064828
Canada	2753947
Germany	122011100019
Austria	393627
Canada	3043910

Supplementary Protection Certificates for bromfenac sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	C 2011 004	Romania		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		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	SPC/GB11/054	United Kingdom		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		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22