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Last Updated: November 17, 2019

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Bromfenac sodium - Generic Drug Details

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What are the generic 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 Pharms Ltd, Amring Pharms, Apotex Inc, Coastal Pharms, Hi Tech, Innopharma Licensing, Paddock Llc, Sun Pharma Global, and Bausch And Lomb, and is included in eleven 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.

Drug Prices for bromfenac sodium

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Recent Clinical Trials for bromfenac sodium

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SponsorPhase
Ministry of Health, ChinaN/A
Sun Yat-sen UniversityN/A
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Recent Litigation for bromfenac sodium

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District Court Litigation
Case NameDate
SENJU PHARMACEUTICAL CO., LTD v. AUROBINDO PHARMA USA INC.2019-06-03
SENJU PHARMACEUTICAL CO., LTD. v. AMNEAL PHARMACEUTICALS LLC2018-12-07
SENJU PHARMACEUTICAL CO., LTD. v. HI-TECH PHARMACAL CO. INC.2016-04-22

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PTAB Litigation
PetitionerDate
InnoPharma Licensing, Inc.2015-11-02
Lupin Ltd.2015-09-04
Lupin Ltd.2015-04-23

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Pharmacology for bromfenac sodium
Synonyms for bromfenac sodium
120638-55-3
2-AMINO-3-(4-BROMOBENZOYL)BENZENEACETIC ACID SODIUM SALT
2-Amino-3-(4-bromobenzoyl)benzeneacetic Acid Sodium Salt Hydrate
2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID SODIUM
2285AH
91714-93-1
9X8YF771OU
AC-149
AC-9334
AHR 10282B
AHR-10282B
AKOS000280377
AN-594
API0000432
BC005156
BC238440
BDBM50225143
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-, monosodium salt
Benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-,monosodium salt
Bromday
Bromfenac sodium anhydrous
bromfenac sodium salt
bromfenac sodium salt sesquihydrate
Bromfenac sodium, >=98% (HPLC)
BromSite
Bronuck
C15H11BrNO3.Na
CHEBI:140536
CHEMBL751
CTK8E6674
DTXSID70273981
FT-0080506
FT-0084337
FT-0602701
FT-0660252
HMS3652D21
HZFGMQJYAFHESD-UHFFFAOYSA-M
I14-15725
J-004372
KS-00000654
MFCD03701673
MolPort-005-938-273
Prolensa
Q-200752
RT-011819
s4248
SB17363
SC-82804
SCHEMBL56644
Sodium (2-amino-3-(4-bromobenzoyl)phenyl)acetate
sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate
sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate
sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate
sodium 2-amino-3-(4-bromobenzoyl) phenylacetate
Sodium; [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetate
SW219148-1
UNII-9X8YF771OU
Xibrom
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
Paddock Llc BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 201941-001 Feb 10, 2015 DISCN No 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
Apotex Inc BROMFENAC SODIUM bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 202620-001 Jun 23, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb Inc BROMDAY bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 021664-002 Oct 16, 2010 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for bromfenac sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
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 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 1190018-0 Sweden   Start Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316 11C0031 France   Start Trial PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/11/692/001 DU 20110518; REGISTRATION NO/DATE AT EEC: EU/1/11/692/001 DU 20110518
1586316 2011C/027 Belgium   Start 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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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
AstraZeneca
Boehringer Ingelheim
Colorcon
Moodys

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