BROMFENAC SODIUM - Generic Drug Details

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What are the generic 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, Amneal, 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 nineteen 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.

Thirteen suppliers are listed for this compound.

Summary for BROMFENAC SODIUM

International Patents:	30
US Patents:	10
Tradenames:	5
Applicants:	14
NDAs:	19
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	6
Patent Applications:	382
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
Coastal Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201211-001	May 11, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201941-001	Feb 10, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	207334-001	Jul 8, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	202620-001	Jun 23, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	214340-001	Jul 8, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes	⤷ 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 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	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	⤷ Sign Up	⤷ Sign Up
>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
Canada	3043910	PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID)	⤷ Sign Up
Canada	2753947	COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STEROIDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS)	⤷ Sign Up
Denmark	2403493		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013055856		⤷ Sign Up
Canada	2944832	PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID)	⤷ Sign Up
Spain	2301964		⤷ Sign Up
>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	2011C/027	Belgium	⤷ Sign Up	PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	132011901975261	Italy	⤷ Sign Up	PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	11C0031	France	⤷ Sign Up	PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	1190018-0	Sweden	⤷ Sign Up	RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	SPC/GB11/054	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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