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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Chinese Patent Office
Fish and Richardson
Moodys
Argus Health
US Department of Justice
Julphar
Mallinckrodt

Generated: May 27, 2018

DrugPatentWatch Database Preview

PROLENSA Drug Profile

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When do Prolensa patents expire, and what generic alternatives are available?

Prolensa is a drug marketed by Bausch And Lomb and is included in one NDA. There are eight 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. Five 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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 Submissiondate
➤ Subscribe Ophthalmic Solution 0.07% ➤ Subscribe 2013-07-26

Non-Orange Book US Patents for PROLENSA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,497,304 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PROLENSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90018-0 Sweden ➤ Try a Free Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
C0031 France ➤ Try a Free 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
00494 Netherlands ➤ Try a Free Trial PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
C/GB11/054 United Kingdom ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Baxter
Farmers Insurance
Johnson and Johnson
Accenture
Dow
Daiichi Sankyo
UBS

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