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
Japan	H02124817	TREATMENT MEDICINE OF INFLAMMATORY AILMENT FOR LOCAL DOSAGE
Spain	2052784

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	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); 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

Market Dynamics and Financial Trajectory for XIBROM (Bromfenac Sodium Ophthalmic Solution)

Last updated: March 8, 2026

What Is XIBROM and Its Approved Indications?

XIBROM (bromfenac sodium ophthalmic solution) is an NSAID developed for ophthalmic use. Approved by the FDA in 2005, it primarily treats postoperative inflammation and pain following ocular surgery, including cataract removal.[1]

Market Entry and Regulatory Timeline

• Initial FDA Approval: 2005
• Indications: Post-op ocular inflammation, pain
• Patent Life: Patent expired in the US in 2014; exclusivity extended through other IP rights and formulations.

Market Size and Growth Drivers

Global Ophthalmic NSAID Market

Projected to reach $1.5 billion by 2026, growing at a CAGR of approximately 4%. The primary drivers include increases in cataract surgeries, rising aging populations, and advancements in ophthalmic disease management.[2]

Regional Market Breakdown

Region	Market Share	Growth Rate (2021–2026)
North America	45%	3.5%
Europe	25%	3.8%
Asia-Pacific	20%	4.2%
Rest of World	10%	4.0%

North America dominates due to higher surgical volumes and reimbursement infrastructure. Asia-Pacific shows the highest growth rate driven by increasing healthcare access and economic development.

Competitive Landscape

Key competitors include:

• Nepafenac (Nevanac, Ilevro): Approved for postoperative pain and inflammation. Market share has increased due to its favorable efficacy profile.
• Ketorolac (Acular): Widely used, with over-the-counter options in some regions.
• Nepafenac (Nevanac, Ilevro): Noted for its improved penetration and reduced dosing frequency.

XIBROM's market share has declined post-patent expiry but remains relevant where branded preferences persist.

Pricing and Reimbursement Dynamics

• Average Wholesale Price (AWP) in the US: Approximately $50 per 5 mL vial.
• Post-patent expiry: Generic bromfenac became available around 2014, leading to significant price reductions—up to 50%—and increased accessibility.
• Reimbursement Policies: Covered widely under Medicare and private insurers, with formularies favoring branded drugs in certain cases.

Patent and Intellectual Property Strategy

With patent expiry in the US in 2014, Bayer shifted focus towards:

• Developing new formulations, including sustained-release delivery systems.
• Expanding approved indications, such as dry eye disease.
• Filing patents on these innovations to extend market exclusivity.

R&D Pipeline and Future Trajectory

Bayer's ongoing R&D efforts aim at:

• Ocular drug delivery innovations: sustained-release implants, nanoparticle formulations.
• New indications: diabetic retinopathy and age-related macular degeneration.
• Combination therapies with corticosteroids.

While no new formulations of XIBROM are publicly announced, innovation in delivery mechanisms may influence future market dynamics, potentially revitalizing the brand.

Financial Performance Indicators

• Sales: Peak global sales reached approximately $150 million annually around 2010. Post-generic entry, sales declined by over 70%.
• Research & Development Spending: Bayer invests around $2 billion annually globally; specific R&D devoted to ophthalmic NSAIDs remains undisclosed.
• Market Share Trends: From over 80% pre-patent expiry to less than 10% today in the US, replaced largely by generics and alternative branded therapies.

Regulatory Risks and Opportunities

• The potential for new formulations to extend exclusivity.
• Regulatory approval hurdles for innovative delivery methods.
• Reimbursement landscape favoring generics could pressure profit margins.

Key Takeaways

• XIBROM had a strong market presence from 2005 until patent expiry in 2014.
• Post-expiry, affordable generics and branded competitors have diminished sales.
• Growth is driven mainly by regional increases in ophthalmic surgeries, especially in Asia.
• Future revenue streams hinge on formulation innovation and expanding indications.
• Bayer’s strategic patent filings on new delivery systems could influence future market share.

FAQs

How has the patent expiry affected XIBROM’s market share?

It reduced sales in the US from over $100 million annually to a fraction, with generics capturing the bulk of prescriptions.

What are the primary competitors for XIBROM?

Nepafenac (Ilevro, Nevranac), ketorolac (Acular), and other emerging NSAID ophthalmic solutions.

Which regions offer the most growth potential?

Asia-Pacific and Latin America, due to expanding surgical volume and increasing healthcare access.

Could new formulations reverse declining sales?

Yes; sustained-release implants or novel delivery methods can create patentable products, potentially reviving market share.

What are the main risks for future revenue generation?

Generic competition, regulatory delays for new delivery systems, and reimbursement pressures.

References

[1] U.S. Food and Drug Administration. (2005). XIBROM (bromfenac sodium ophthalmic solution) NDA 21-343. Retrieved from https://www.accessdata.fda.gov

[2] Grand View Research. (2022). Ophthalmic Drugs Market Size, Share & Trends Analysis Report.