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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Boehringer Ingelheim
Citi
Chinese Patent Office
Fuji
Farmers Insurance
Healthtrust
Chubb

Generated: December 18, 2018

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PROLENSA Drug Profile

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Which patents cover Prolensa, and when can generic versions of Prolensa launch?

Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in thirteen countries.

The generic ingredient in PROLENSA 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.

Drug patent expirations by year for PROLENSA
Pharmacology for PROLENSA
Synonyms for PROLENSA
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 PROLENSA

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 PROLENSA
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.07% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PROLENSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90018-0 Sweden ➤ Sign Up RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
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
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
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:

Daiichi Sankyo
Express Scripts
Boehringer Ingelheim
Citi
Chinese Patent Office
Fuji
Farmers Insurance
Healthtrust
Chubb

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