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, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Rising, Sun Pharm, and Bausch And Lomb, and is included in thirteen 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.

Seven suppliers are listed for this compound.

Summary for bromfenac sodium

International Patents:	30
US Patents:	10
Tradenames:	5
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	6
Patent Applications:	719
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
Ministry of Health, China	N/A
Sun Yat-sen University	N/A

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	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		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eugia Pharma	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	204813-001	Mar 18, 2022	AT2	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Amring Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	202030-001	Jan 9, 2013		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Alembic Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	210560-001	Jun 21, 2019	AT2	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
>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
Germany	602004013420		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2004064828		See Plans and Pricing
Mexico	2014004347	COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.)	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2015170177		See Plans and Pricing
European Patent Office	2765988	COMPOSITION CONTENANT BROMOFENAC À L'ADMINISTRATION À VOIE OCULAIRE AVEC UNE BIODISPONIBILITÉ AUGMENTÉ (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY)	See Plans and Pricing
Portugal	2403493		See Plans and Pricing
>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	SPC/GB11/054	United Kingdom	See Plans and Pricing	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	1190018-0	Sweden	See Plans and Pricing	RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	2011C/027	Belgium	See Plans and Pricing	PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	11C0031	France	See Plans and Pricing	PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C 2011 004	Romania	See Plans and Pricing	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	122011100019	Germany	See Plans and Pricing	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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