PROLENSA Drug Patent Profile

When do Prolensa patents expire, 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-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
Ocular Therapeutix, Inc.	Phase 4
Sight Medical Doctors PLLC	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

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

International Patents for PROLENSA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2765988	COMPOSITION CONTENANT BROMOFENAC À L'ADMINISTRATION À VOIE OCULAIRE AVEC UNE BIODISPONIBILITÉ AUGMENTÉ (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY)
Mexico	348418	COMPOSICION OCULAR QUE CONTIENE BROMFENACO CON BIODISPONIBILIDAD INCREMENTADA. (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY.)
World Intellectual Property Organization (WIPO)	2015170177

Supplementary Protection Certificates for PROLENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	11C0031	France		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518