XIBROM Drug Patent Profile

Which patents cover Xibrom, and when can generic versions of Xibrom launch?

Xibrom is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

The generic ingredient in XIBROM 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 Xibrom

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

Summary for XIBROM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	9
Patent Applications:	4,489
DailyMed Link:	XIBROM at DailyMed

Recent Clinical Trials for XIBROM

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

Sponsor	Phase
Sun Pharma Global FZE	Phase 1/Phase 2
InSite Vision	Phase 1/Phase 2
Allergan	Phase 4

See all XIBROM clinical trials

US Patents and Regulatory Information for XIBROM

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 Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005		DISCN	Yes	No

Expired US Patents for XIBROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005

International Patents for XIBROM

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

Country	Patent Number	Title	Estimated Expiration
Austria	80043
Greece	3005586
Japan	H02124817	TREATMENT MEDICINE OF INFLAMMATORY AILMENT FOR LOCAL DOSAGE
Philippines	26827	A locally administrable therapeutic composition for inflammatory disease
European Patent Office	0326915	A LOCALLY ADMINISTRABLE THERAPEUTIC COMPOSITION FOR INFLAMMATORY DISEASE

Supplementary Protection Certificates for XIBROM

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	132011901975261	Italy		PRODUCT NAME: BROMFENAC(YELLOX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/692/001, 20110518
1586316	2011C/027	Belgium		PRODUCT NAME: BROMFENAC; AUTHORISATION NUMBER AND DATE: EU/1/11/692/001 20110523
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
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

Market Dynamics and Financial Trajectory for XIBROM

Last updated: July 29, 2025

Introduction

XIBROM (bromfenac ophthalmic solution) is a non-steroidal anti-inflammatory drug (NSAID) primarily used to manage postoperative ocular inflammation and pain following cataract surgery. Since its approval, its market performance and financial prospects are influenced by evolving clinical practices, competitive landscape, regulatory environments, and broader healthcare trends. This analysis elucidates the current market dynamics and projects its financial trajectory, providing insight into strategic opportunities for stakeholders.

Market Overview

Therapeutic Role and Clinical Application

XIBROM serves as a topical NSAID targeting ocular inflammation, a common complication post-cataract surgery. Its efficacy in reducing inflammation and pain has been well-established, leading to widespread adoption in ophthalmology. The drug's targeted mechanism and favorable safety profile position it as a preferred choice among ophthalmic NSAIDs, especially in surgical settings.

Market Penetration and Adoption

Since its launch in 2008, XIBROM has gained significant market share within the ophthalmic NSAID sector. Its adoption relies heavily on ophthalmologists' preferences, surgical volume, and reimbursement policies. The drug's integration into standard postoperative care protocols has cemented its role, but competition from generic NSAIDs and alternative formulations influences market dynamics.

Regulatory and Patent Landscape

XIBROM's patent estate has historically provided exclusivity, safeguarding its market position. However, patent expirations and entry of generics—such as bromfenac-based formulations from other manufacturers—have intensified price competition. Regulatory approvals in multiple regions expand its global footprint but also subject it to diverse regulatory standards, influencing commercialization strategies.

Competitive and Market Forces

Competitive Landscape

The OR (ophthalmic NSAID) market is fragmented, with key competitors including alternatives like Nepafenac (e.g., Nevenac, Ilevro), Diclofenac, and Ketorolac formulations. Generics have eroded XIBROM's market share, especially in price-sensitive environments. Innovations in drug delivery, such as sustained-release implants or new topical formulations, may threaten traditional NSAID products.

Pricing and Reimbursement

Reimbursement policies significantly impact XIBROM’s market penetration. The presence of cheaper generics forces pricing strategies to balance profitability with market competitiveness. Insurance coverage and healthcare provider incentives also influence prescribing patterns.

Clinical Guidelines and Physician Preferences

Evolving clinical guidelines favor NSAID use in preventing cystoid macular edema (CME) post-cataract surgery, sustaining demand for XIBROM. Physician familiarity and clinical experience further embed the drug into standard care, although preferences for newer or more convenient formulations may shift demand.

Regulatory Initiatives and Safety Profile

Regulatory bodies prioritize safety, efficacy, and cost-effectiveness. XIBROM’s favorable safety profile promotes ongoing usage; any safety concerns or new efficacy data could influence its market dynamics. Regulatory approvals for extended indications or new formulations open avenues for growth.

Market Drivers and Restraints

Drivers

• Increasing cataract surgeries globally: The expanding aging population and technological advancements in surgical techniques drive demand for postoperative anti-inflammatory agents.
• Clinical guideline endorsements: Recommendations supporting NSAID use enhance market stability.
• Product innovation: Formulation improvements offering convenience may attract new users.
• Expanding markets: Growth in emerging economies extends XIBROM’s reach.

Restraints

• Patent expiry and generic competition: Reduced pricing power and market share erosion threaten profitability.
• Cost containment pressures: Payers demanding cost-effective alternatives push prescriptions toward less expensive generics.
• Emergence of alternative therapies: Sustained-release implants and combination products could displace traditional topical NSAIDs.

Financial Trajectory and Forecasting

Historical Performance

Initially, XIBROM demonstrated robust revenue growth during the late 2000s and early 2010s, supported by post-market adoption and clinical guideline endorsements. However, revenue growth has plateaued owing to patent expiration, heightened generic competition, and pricing pressures.

Projected Revenue Trends

Forecasting suggests a moderate decline in proprietary sales over the next five years, primarily attributable to generic erosion. Nonetheless, geographic expansion, especially into emerging markets, could moderate revenue decline, complemented by strategic launches of new formulations or indications.

Impact of Patent Expiry and Generics

The expiration of key patents—such as the core formulation patent—has initiated increased generic penetration. Industry estimates indicate that generic bromfenac formulations could account for over 70% of ophthalmic NSAID sales in mature markets within five years, substantially impacting XIBROM's revenue.

Strategic Growth Opportunities

• Diversification into new indications: Extending XIBROM’s use beyond postoperative inflammation (e.g., dry eye disease) could diversify revenue streams.
• Innovative delivery systems: Investment in sustained-release implants or combination therapies can enhance differentiation and retain customer loyalty.
• Global expansion: Penetrating underpenetrated markets with tailored pricing strategies could sustain overall sales.

Potential Revenue Outlook

Under conservative assumptions, XIBROM’s global sales may decline by approximately 10-15% annually over the next three years absent strategic interventions. However, proactive diversification and market expansion could temper this decline or foster stabilization.

Regulatory and Industry Outlook

Regulatory agencies worldwide are emphasizing safety and efficacy data transparency. Approvals for new formulations or extended indications will influence market trajectory. Industry consolidation, collaborations, and licensing could create licensing income and market synergies, impacting revenue flow.

Key Takeaways

• The XIBROM market is facing inherent challenges from patent expirations and increasing generic competition, constraining top-line growth.
• Strategic deployment of new formulations, indications, and market expansion initiatives remain critical to offset revenue erosion.
• The expanding volume of cataract surgeries and evolving clinical guidelines favor continued, albeit moderated, demand.
• Price sensitivity driven by payer policies necessitates innovative pricing and access strategies.
• Future growth hinges on diversification, delivery innovations, and successful penetration into emerging markets.

FAQs

1. How will patent expirations impact XIBROM’s market share?
Patent expirations open the market to generics, significantly reducing proprietary sales and pressuring prices. The extent of market share decline depends on the success of generic entrants and the company's strategic responses.

2. What competitive advantages can XIBROM leverage amid growing generic competition?
XIBROM’s established safety profile, clinician familiarity, and potential for new indications or formulations can sustain demand. Investing in innovative delivery systems offers further differentiation.

3. Which markets represent the most promising growth opportunities for XIBROM?
Emerging markets with rising cataract surgery volumes and expanding healthcare infrastructure present significant growth opportunities, especially with tailored pricing and localized regulatory strategies.

4. How might regulatory developments affect XIBROM’s future?
Approval of new formulations, extended indications, and favorable safety profiles will bolster market prospects. Conversely, safety concerns or regulatory delays could hinder product adoption.

5. What strategic steps should stakeholders consider to enhance XIBROM’s financial trajectory?
Invest in pipeline diversification, pursue formulation innovations, expand into underpenetrated markets, and strengthen relationships with ophthalmologists through education and evidence-based outcomes.

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Sources:

1. U.S. FDA drug approval databases and label information.
2. Market research reports on ophthalmic NSAIDs, including EvaluatePharma and IQVIA insights.
3. Industry publications and ophthalmology practice guidelines.
4. Patent databases and regulatory filings related to XIBROM and its generics.