BROMSITE Drug Patent Profile

✉ Email this page to a colleague

Which patents cover Bromsite, and what generic alternatives are available?

Bromsite is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in six countries.

The generic ingredient in BROMSITE is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bromsite

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

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for BROMSITE?
What are the global sales for BROMSITE?
What is Average Wholesale Price for BROMSITE?

Summary for BROMSITE

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	204
Patent Applications:	171
Drug Prices:	Drug price information for BROMSITE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BROMSITE
What excipients (inactive ingredients) are in BROMSITE?	BROMSITE excipients list
DailyMed Link:	BROMSITE at DailyMed

Drug patent expirations by year for BROMSITE

Pharmacology for BROMSITE

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

Paragraph IV (Patent) Challenges for BROMSITE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROMSITE	Ophthalmic Solution	bromfenac sodium	0.075%	206911	1	2017-10-25

US Patents and Regulatory Information for BROMSITE

BROMSITE is protected by one US patents.

Patents protecting BROMSITE

Non-steroidal anti-inflammatory ophthalmic compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	BROMSITE	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206911-001	Apr 8, 2016	AB	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

International Patents for BROMSITE

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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Canada	2753947	COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STEROIDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS)	⤷ Sign Up
Spain	2586064		⤷ Sign Up
Portugal	2403493		⤷ Sign Up
Denmark	2403493		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010102192		⤷ Sign Up
European Patent Office	2403493	COMPOSITIONS OPHTALMIQUES ANTI-INFLAMMATOIRES NON STÉROÏDIENNES (NON-STEROIDAL ANTI-INFLAMMATORY OPHTHALMIC COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BROMSITE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	C300494	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
1586316	132011901975261	Italy	⤷ Sign Up	PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	2011C/027	Belgium	⤷ Sign Up	PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	SPC/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
1586316	122011100019	Germany	⤷ Sign Up	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	C 2011 004	Romania	⤷ Sign Up	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	11C0031	France	⤷ Sign Up	PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description