Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 23, 2019

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four 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
Drug Prices for PROLENSA

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Drug Sales Revenue Trends for PROLENSA

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Recent Clinical Trials for PROLENSA

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SponsorPhase
Silverstein Eye CentersPhase 4
Churchhill CommunicationsPhase 4
Statistics & Data CorporationPhase 4

See all PROLENSA clinical trials

Recent Litigation for PROLENSA

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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

See all PROLENSA litigation

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

See all PROLENSA litigation

Pharmacology for PROLENSA
Synonyms for PROLENSA
[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)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
4CH-007116
4mjq
638B553
864P0921DW
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
AKOS025311220
AN-5545
AN-594
ANW-47053
API0000432
API0009095
AS-15991
AX8118731
BC005156
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)-
Benzeneacetic acid,2-amino-3-(4-bromobenzoyl)-,monosodium salt
BRD-K47679368-323-01-3
Bromday
Bromfenac
Bromfenac (INN)
Bromfenac [INN]
Bromfenac monosodium salt sesquihydrate
BROMFENAC SODIUM
Bromfenac sodium anhydrous
Bromfenac sodium hydrate
bromfenac sodium salt
bromfenac sodium salt sesquihydrate
Bromfenac sodium, >=98% (HPLC)
Bromfenaco
Bromfenaco [Spanish]
Bromfenacum
Bromfenacum [Latin]
BromSite
Bronuck
C-23660
C15H11BrNNaO3.1.5H2O
C15H11BrNO3.Na
C15H11BrNO3.Na.H2O
C15H12BrNO3
CC-25212
CHEBI:140536
CHEBI:240107
CHEMBL1077
CHEMBL751
CTK8B5019
CTK8E6674
D07541
DA-01153
DB00963
DTXSID70273981
DTXSID7040655
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
LS-178156
MFCD03701673
MLS004774052
MolPort-000-883-091
MolPort-005-938-273
MolPort-023-220-529
MP-1093
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-(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
SR-01000941476
SR-01000941476-2
ST24027466
SW219148-1
TC-135798
UNII-864P0921DW
UNII-9X8YF771OU
W9506
Xibrom
Xibrom QD
XiDay
Yellox
ZBPLOVFIXSTCRZ-UHFFFAOYSA-N
ZINC2570817

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   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 Y Y   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
Bausch And Lomb PROLENSA bromfenac sodium SOLUTION/DROPS;OPHTHALMIC 203168-001 Apr 5, 2013 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
Paragraph IV (Patent) Challenges for PROLENSA
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Solution 0.07% ➤ Subscribe   Start Trial

Supplementary Protection Certificates for PROLENSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 1190018-0 Sweden   Start Trial RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
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Harvard Business School
Mallinckrodt
Merck
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.