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Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKesson
AstraZeneca
Moodys
Johnson and Johnson

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

BROMSITE Drug Profile

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When do Bromsite patents expire, and when can generic versions of Bromsite launch?

Bromsite is a drug marketed by Sun Pharma Global and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in six countries.

The generic ingredient in BROMSITE is bromfenac sodium. Five suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for BROMSITE
Drug patent expirations by year for BROMSITE
Drug Prices for BROMSITE

See drug prices for BROMSITE

Pharmacology for BROMSITE
Synonyms for BROMSITE
[2-Amino-3-(4-bromo-benzoyl)-phenyl]-acetic acid
[2-amino-3-(4-bromobenzoyl)phenyl]acetic acid
{2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic acid
120638-55-3
2-(2-Amino-3-(4-bromobenzoyl)phenyl)acetic acid
2-[2-amino-3-(4-bromobenzoyl)phenyl]acetic acid
2-[2-amino-3-[(4-bromophenyl)-oxomethyl]phenyl]acetic acid
2-[2-azanyl-3-(4-bromophenyl)carbonyl-phenyl]ethanoic acid
2-{2-amino-3-[(4-bromophenyl)carbonyl]phenyl}acetic acid
2-amino-3-(4-bromobenzoyl)benzene-acetic acid sodium salt sesquihydrate
2-Amino-3-(4-bromobenzoyl)benzeneacetic acid
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
2722AH
27R
2C15H11BrNO3.2Na.H2O
4CH-007116
4mjq
638B553
864P0921DW
8ECV571Y37
91714-93-1
91714-93-1 (Na salt)
91714-94-2
9X8YF771OU
A844048
AB0027651
AC-149
AC-9334
AC1L1TSW
AC1Q5DQ7
AHR 10282
AHR 10282B
AHR-10282
AHR-10282B
AJ-41875
AK-85648
AKOS000280377
AKOS015998697
AKOS016008745
AKOS025311220
AN-5545
AN-594
ANW-47053
API0000432
API0009095
AS-15991
AX8118731
BC005156
BC215663
BC238440
BDBM50225143
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-, monosodium salt
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-, monosodium salt, hydrate (2:3)
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-, monosodium salt, sesquihydrate
Benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-
Benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-,monosodium salt
BRD-K47679368-323-01-3
Bromday
Bromday (TN)
Bromfenac
Bromfenac (INN)
Bromfenac [INN]
Bromfenac monosodium salt sesquihydrate
Bromfenac ophthalmic
Bromfenac ophthalmic solution
BROMFENAC SODIUM
Bromfenac sodium (USAN)
Bromfenac sodium [USAN]
Bromfenac sodium anhydrous
Bromfenac sodium hydrate
Bromfenac sodium hydrate (JAN)
bromfenac sodium salt
bromfenac sodium salt sesquihydrate
Bromfenac Sodium Sesquihydrate
Bromfenac sodium, >=98% (HPLC)
Bromfenac(sodiumhydrate)
Bromfenaco
Bromfenaco [Spanish]
Bromfenacum
Bromfenacum [Latin]
Bronuck
C-23660
C15H11BrNNaO3.1.5H2O
C15H11BrNO3.Na
C15H11BrNO3.Na.H2O
C15H12BrNO3
CAS-120638-55-3
CC-25212
CHEBI:140536
CHEBI:240107
CHEBI:59176
CHEMBL1077
CHEMBL3181947
CHEMBL751
CTK8B5019
CTK8E6674
D03163
D07541
DA-01153
DB00963
disodium;2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate;trihydrate
DSSTox_CID_24206
DSSTox_GSID_44206
DSSTox_RID_80119
DTXSID70273981
DTXSID7040655
DTXSID8044206
Duract
EBD87057
EBD898487
FT-0080506
FT-0084337
FT-0602701
FT-0660252
FT-0710423
GS-3830
GTPL7131
HMS3652D21
HZFGMQJYAFHESD-UHFFFAOYSA-M
I14-15725
ISV-101
ISV-303
J-004372
J-519935
KB-295409
KS-00000654
KS-00000FTU
KS-00001FCL
LS-172462
LS-178156
MFCD03701673
MLS004774052
MolPort-000-883-091
MolPort-005-938-273
MolPort-023-220-529
MolPort-027-948-611
MP-1093
NCGC00164552-01
NCGC00263519-01
Prolensa
Prolensa (TN)
Q-200752
R722
Remura
RT-011819
s4248
SB17362
SB17363
SC-82804
SCHEMBL34411
SCHEMBL56644
SCHEMBL57565
SMR003500721
Sodium (2-amino-3-(4-bromobenzoyl)phenyl)acetate
Sodium (2-amino-3-(p-bromobenzoyl)phenyl)acetate sesquihydrate
sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate
sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate sesquihydrate
sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate--water (2/3)
sodium [2-amino-3-(p-bromobenzoyl)phenyl]acetate sesquihydrate
sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate
Sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate hydrate(2:2:3)
Sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate trihydrate
sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate
sodium 2-amino-3-(4-bromobenzoyl) phenylacetate
sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate
Sodium; [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetate
SR-01000941476
SR-01000941476-2
ST24027466
SW219148-1
TC-135798
Tox21_112181
Tox21_112181_1
UNII-864P0921DW
UNII-8ECV571Y37
UNII-9X8YF771OU
W9506
Xibrom
Xibrom (TN)
Xibrom QD
XiDay
Yellox
Yellox (TN)
ZBPLOVFIXSTCRZ-UHFFFAOYSA-N
ZINC2570817
Paragraph IV (Patent) Challenges for BROMSITE
Tradename Dosage Ingredient NDA Submissiondate
BROMSITE SOLUTION/DROPS;OPHTHALMIC bromfenac sodium 206911 2017-10-25

US Patents and Regulatory Information for BROMSITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 RX Yes Yes   Start Trial   Start Trial   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 BROMSITE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C 2011 004 Romania   Start 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 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 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316 2011C/027 Belgium   Start Trial PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Baxter
Medtronic
McKesson
Mallinckrodt

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