prolensa Drug Patent Profile

Which patents cover Prolensa, 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. Ten suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prolensa

A generic version of prolensa was approved as bromfenac sodium by SENTISS on January 22^nd, 2014.

Summary for prolensa

International Patents:	24
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	5
Patent Applications:	5,335
Drug Prices:	Drug price information for prolensa
Drug Sales Revenues:	Drug sales revenues for prolensa
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for prolensa
What excipients (inactive ingredients) are in prolensa?	prolensa excipients list
DailyMed Link:	prolensa at DailyMed

See drug prices for prolensa

See drug sales revenues for prolensa

Recent Clinical Trials for prolensa

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wyse Eyecare	Phase 4
Sight Medical Doctors PLLC	Phase 4
Ocular Therapeutix, Inc.	Phase 4

See all prolensa clinical trials

Pharmacology for prolensa

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for prolensa

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for PROLENSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROLENSA	Ophthalmic Solution	bromfenac sodium	0.07%	203168	1	2013-07-26

US Patents and Regulatory Information for prolensa

prolensa is protected by ten US patents.

Patents protecting 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	AB	RX	Yes	Yes
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			Y
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			Y	Y
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	AB	RX	Yes	Yes			Y

Expired US Patents for prolensa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013

International Patents for prolensa

See the table below for patents covering prolensa around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2944832	PREPARATION LIQUIDE AQUEUSE CONTENANT DE L'ACIDE 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIQUE (AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID)
South Korea	20050092691	AQUEOUS LIQUID PREPARATION CONTAINING 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID
Canada	2852995	COMPOSITION OPHTALMIQUE QUI CONTIENT DU BROMFENAC PRESENTANT UNE BIODISPONIBILITE ACCRUE (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY)
Hungary	S1100022
Austria	393627
Portugal	1586316

Supplementary Protection Certificates for prolensa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	132011901975261	Italy		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	C300494	Netherlands		PRODUCT NAME: BROMFENAC, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C 2011 004	Romania		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	2011C/027	Belgium		PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	11C0031	France		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	SPC/GB11/054	United Kingdom		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