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Generated: December 16, 2018

DrugPatentWatch Database Preview

BROMSITE Drug Profile

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Which patents cover Bromsite, and what generic alternatives are available?

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. There are ten drug master file entries for this compound. Four 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
Pharmacology for BROMSITE
Synonyms for BROMSITE
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
AKOS000280377
AN-594
API0000432
BC005156
BC238440
Benzeneacetic acid, 2-amino-3-(4-bromobenzoyl)-, monosodium salt
Benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-,monosodium salt
BROMFENAC SODIUM
Bromfenac sodium anhydrous
bromfenac sodium salt
Bromfenac sodium, >=98% (HPLC)
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
KS-1199
MFCD03701673
MolPort-005-938-273
Q-200752
RT-011819
s4248
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-amino-3-(4-bromobenzoyl) phenylacetate
Sodium; [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetate
UNII-9X8YF771OU

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharma Global BROMSITE bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 206911-001 Apr 8, 2016 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

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Paragraph IV (Patent) Challenges for BROMSITE
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.075% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for BROMSITE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0031 France ➤ Sign Up 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
C/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
00494 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Accenture
McKesson
Cantor Fitzgerald
Baxter
US Department of Justice
AstraZeneca
US Army
Deloitte

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