Bromfenac sodium - Generic Drug Details

What are the generic drug sources for bromfenac sodium and what is the scope of patent protection?

Bromfenac sodium is the generic ingredient in five branded drugs marketed by Bausch And Lomb Inc, Alembic, Amneal, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland, Lupin Ltd, Rising, Sentiss, Sun Pharm, and Bausch And Lomb, and is included in nineteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bromfenac sodium has thirty-nine patent family members in nineteen countries.

Thirteen suppliers are listed for this compound.

Summary for bromfenac sodium

International Patents:	39
US Patents:	4
Tradenames:	5
Applicants:	14
NDAs:	19
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Drug Prices:	Drug price trends for bromfenac sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bromfenac sodium
What excipients (inactive ingredients) are in bromfenac sodium?	bromfenac sodium excipients list
DailyMed Link:	bromfenac sodium at DailyMed

See drug prices for bromfenac sodium

Recent Clinical Trials for bromfenac sodium

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

Sponsor	Phase
Seoul National University Hospital	Phase 2
Bausch & Lomb Incorporated	PHASE4
Retina Research Institute, LLC	PHASE4

See all bromfenac sodium clinical trials

Pharmacology for bromfenac sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for bromfenac sodium

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

Paragraph IV (Patent) Challenges for BROMFENAC SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROMSITE	Ophthalmic Solution	bromfenac sodium	0.075%	206911	1	2017-10-25
PROLENSA	Ophthalmic Solution	bromfenac sodium	0.07%	203168	1	2013-07-26

US Patents and Regulatory Information for bromfenac sodium

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	8,129,431		Y	Y
Sentiss	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203395-001	Jan 22, 2014	AT2	RX	No	No
Bausch And Lomb Inc	BROMDAY	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-002	Oct 16, 2010		DISCN	Yes	No
Coastal Pharms	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	201211-001	May 11, 2011		DISCN	No	No
Sun Pharm	BROMSITE	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206911-001	Apr 8, 2016	AB	RX	Yes	Yes	RE50218		Y
Lupin Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206027-001	Nov 22, 2023	AB	RX	No	No
Lupin Ltd	BROMFENAC SODIUM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	202903-001	Aug 15, 2023	AT2	RX	No	No

Expired US Patents for bromfenac sodium

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	9,561,277
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,129,431
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	9,144,609
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,871,813
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,927,606
Bausch And Lomb	PROLENSA	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	203168-001	Apr 5, 2013	8,754,131
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005	4,910,225

International Patents for bromfenac sodium

Country	Patent Number	Title	Estimated Expiration
South Korea	101059711
Spain	2301964
World Intellectual Property Organization (WIPO)	2013055856
Canada	2852995	COMPOSITION OPHTALMIQUE QUI CONTIENT DU BROMFENAC PRESENTANT UNE BIODISPONIBILITE ACCRUE (OCULAR COMPOSITION CONTAINING BROMFENAC WITH INCREASED BIOAVAILABILITY)
World Intellectual Property Organization (WIPO)	2010102192
Hungary	E069597
Germany	602004013420

Supplementary Protection Certificates for bromfenac sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1586316	1190018-0	Sweden		RAETTELSE AV SKYDDSTID: 2024-01-17 TILL OCH MED DEN 2026-05-22
1586316	2011C/027	Belgium		PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
1586316	132011901975261	Italy		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): 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

Market Dynamics and Financial Trajectory for Bromfenac Sodium

Last updated: July 27, 2025

Introduction

Bromfenac sodium is a non-steroidal anti-inflammatory drug (NSAID) primarily utilized in ophthalmology to manage postoperative inflammation and pain associated with ocular surgeries such as cataract extraction. Its unique pharmacological profile has positioned it as a key player within the ocular anti-inflammatory market. This analysis evaluates the current market landscape, growth drivers, competitive environment, regulatory influences, and future financial outlook for bromfenac sodium.

Pharmacological Profile and Clinical Application

Bromfenac sodium, marketed under brands like Xibrom and BromSite, functions as a potent cyclooxygenase (COX) inhibitor, reducing inflammation and pain by suppressing prostaglandin synthesis. Its high lipophilicity facilitates ocular penetration, enabling effective treatment of intraocular and periocular inflammation. The drug’s favorable ocular bioavailability and once-daily dosing schedule enhance patient compliance, bolstering its clinical adoption.

Market Drivers

Rising Incidence of Cataract Surgeries

The global increase in cataract surgeries is a principal growth driver. According to the World Health Organization (WHO), cataracts are responsible for approximately 51% of global blindness, with surgical interventions increasing annually [1]. The expanding aging population and improved surgical techniques contribute to this surge, necessitating effective anti-inflammatory agents like bromfenac sodium.

Advancements in Ophthalmic Therapeutics

Innovations in ophthalmic drug delivery systems and formulation enhancements, including preservative-free options, have improved drug efficacy and safety profiles. These advances attract ophthalmologists toward bromfenac sodium-based therapies for postoperative care.

Regulatory Approvals and Expanded Indications

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved bromfenac formulations for various ocular inflammatory conditions, widening its market scope. Ongoing clinical trials examining off-label and extended-use applications may further expand its indications.

Market Penetration of Branded and Generic Formulations

While branded products hold significant market share, the introduction of generic bromfenac sodium formulations offers cost advantages, improving access in Tier 2 and Tier 3 markets. This price competitiveness is vital for capturing emerging economies’ markets.

Competitive Landscape

The bromfenac sodium market features key players such as Alcon (BromSite), Sun Pharma (rIVA), and Novartis (Bromfenac ophthalmic solutions). The competitive environment emphasizes product differentiation through formulation improvements, preservative-free options, and combination therapies.

Alcon’s BromSite, combining bromfenac with dexamethasone, exemplifies a strategic move toward multi-mechanistic approaches for pain and inflammation management, expanding their market dominance. Meanwhile, Sun Pharma has gained significant market traction through cost-effective generic formulations.

Emerging competitors are focusing on novel delivery devices and biosimilar development to gain comparative advantages, thereby intensifying competitive pressures.

Regulatory and Patent Landscape

Patent expirations have facilitated the proliferation of generics, impacting pricing and market share dynamics. For instance, Alcon’s patents for BromSite faced challenges in key jurisdictions, paving the way for generic entrants.

Regulatory pathways for new formulations, such as preservative-free drops and sustained-release implants, are under development, aiming to improve patient outcomes and compliance.

Market Challenges

Pricing Pressures and Reimbursement Policies

Price sensitivity, especially in developing countries, constrains revenue growth. Reimbursement algorithms favor cost-effective generic options, reducing profit margins for branded products.

Safety and Tolerability Concerns

Although generally well tolerated, NSAID-associated risks such as corneal melts and delayed wound healing remain concerns. Enhanced safety profiles and clinician awareness impact prescribing patterns.

Competition from Alternative Therapies

Emerging anti-inflammatory agents, including corticosteroids and novel biologics, challenge bromfenac sodium’s market position, requiring continuous innovation and positioning strategies.

Financial Trajectory and Revenue Forecasts

Historical Market Performance

The global ophthalmic anti-inflammatory drugs market was valued at approximately USD 1.2 billion in 2020, with bromfenac sodium constituting a significant share due to its efficacy and ease of use. The market has shown compound annual growth rates (CAGR) of approximately 5-7% over the past five years [2].

Projected Growth and Revenue Streams

Forecasts suggest the bromfenac sodium market will expand at a CAGR of 6-8% through 2030, driven by increasing cataract surgeries, product innovation, and expanding geographical reach. North America currently dominates with an estimated 45% market share; however, Asia-Pacific is poised for the highest growth rates (~9-10%) due to burgeoning healthcare infrastructure and disease prevalence.

Impact of Patent Expirations and Generics

Patent expirations over the next five years will catalyze an influx of generic formulations, likely reducing branded drug revenues by 20-25%. Nevertheless, premium formulations and combination drugs will sustain profitability for key innovators.

Emerging Opportunities

Development of sustained-release implants and preservative-free drops represent new revenue avenues, potentially increasing overall market size by 10-15%. Clinical trials targeting new indications could further propel financial growth.

Strategic Outlook

To capitalize on emerging trends, pharmaceutical companies should prioritize:

• Investment in novel delivery technologies to enhance patient compliance and treatment efficacy.
• Strategic collaborations and licensing to expand geographical presence.
• R&D focused on safety enhancements and extended indications.
• Market segmentation targeting aging populations and regions with expanding ocular disease burdens.

Regulatory and Policy Influences

Evolving regulatory frameworks emphasizing drug safety and affordability will influence market dynamics. Governments promoting biosimilars and generics will accelerate price competition, necessitating agile strategic responses from market incumbents.

Conclusion

Bromfenac sodium retains a robust position in the ophthalmic anti-inflammatory space, buoyed by the rising volume of ocular surgeries and ongoing innovation. While patent expirations and competitive pressures pose challenges, strategic investments in formulation and delivery advancements, coupled with expanding global access, promise sustained growth. Companies that adapt swiftly to regulatory changes and consumer preferences, while maintaining cost-effective offerings, will dominate the evolving market landscape.

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Key Takeaways

• The increasing global burden of cataracts and ocular surgeries drives demand for bromfenac sodium-based therapies.
• Innovation in formulations—especially preservative-free options—and combination therapies support market expansion.
• Patent expiries facilitate the entry of generics, exerting downward pressure on prices but creating opportunities for cost-effective alternatives.
• Strategic investments in delivery technologies and geographic expansion are critical for sustained growth.
• Regulatory shifts toward safety and affordability influence product development and market positioning.

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FAQs

1. What are the primary clinical uses of bromfenac sodium?
Bromfenac sodium is primarily indicated for reducing postoperative inflammation and pain following ocular surgeries such as cataract extraction and intraocular lens implantation.

2. How does patent expiration affect the bromfenac sodium market?
Patent expirations lead to increased generic competition, reducing prices and margins for branded formulations while expanding access through more affordable options, especially in emerging markets.

3. What innovations are shaping the future of bromfenac sodium formulations?
Developments include preservative-free eye drops, sustained-release implants, and combination therapies designed to improve patient comfort, compliance, and therapeutic efficacy.

4. Which regions are expected to drive most of the growth for bromfenac sodium?
While North America currently dominates, rapid growth is anticipated in Asia-Pacific nations due to increasing surgical procedures and expanding healthcare infrastructure.

5. What are the main challenges facing bromfenac sodium market growth?
Price competition, safety concerns related to NSAID use, regulatory hurdles, and competition from alternative anti-inflammatory therapies represent significant challenges.

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Sources

[1] World Health Organization (WHO). "Global Data on Visual Impairment." 2020.
[2] MarketWatch. "Ophthalmic Anti-Inflammatory Drugs Market Size, Share & Trends Analysis Report." 2022.