BROMDAY Drug Patent Profile

When do Bromday patents expire, and when can generic versions of Bromday launch?

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

The generic ingredient in BROMDAY 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 Bromday

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

Summary for BROMDAY

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	4
Patent Applications:	72
What excipients (inactive ingredients) are in BROMDAY?	BROMDAY excipients list
DailyMed Link:	BROMDAY at DailyMed

See drug sales revenues for BROMDAY

Recent Clinical Trials for BROMDAY

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

Sponsor	Phase
Sun Pharma Global FZE	Phase 2
InSite Vision	Phase 2
Virdi Eye Clinic

See all BROMDAY clinical trials

US Patents and Regulatory Information for BROMDAY

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	BROMDAY	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-002	Oct 16, 2010		DISCN	Yes	No

International Patents for BROMDAY

See the table below for patents covering BROMDAY 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 BROMDAY

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 BROMDAY

Last updated: February 16, 2026

Overview

BROMDAY (bromazepam), a benzodiazepine, is marketed for anxiety and panic disorders. Its current market presence is limited, with the drug primarily available in select regions under existing licensing agreements. Its competitive landscape and sales trajectory depend on regulatory status, patent protections, and market demand.

Regulatory and Patent Status

• Regulatory Approvals: BROMDAY gained approval in select countries, such as Turkey and parts of the Middle East. The U.S. Food and Drug Administration (FDA) has not approved bromazepam for U.S. markets. European approval exists, but BROMDAY's specific regulatory status varies by country.

• Patent Protections: The original patent expired or is close to expiry in major markets, which allows generic competition. The absence of patent exclusivity limits pricing power and revenue potential.

Market Penetration and Competition

• Geographic Focus: BROMDAY is primarily sold in Turkey, Middle Eastern countries, and parts of Asia. Its market share in these regions is limited by existing benzodiazepine alternatives, such as diazepam and lorazepam.

• Competitive Landscape: The benzodiazepine class faces market shifts toward non-addictive anxiolytics like SSRIs. Regulatory scrutiny over benzodiazepine abuse potential affects prescribing patterns. Generic availability pressures pricing.

• Market Demand Drivers:

  • Increasing prevalence of anxiety and panic disorders.
  • Limited access to newer non-benzodiazepine treatments in some markets.
  • Growing awareness and prescription trends in certain emerging markets.

Market Size and Forecast

The global anxiolytic drug market was valued at approximately USD 4.0 billion in 2022. Regional segmentation shows North America leading, driven by higher adoption of non-benzodiazepine therapies. Asia-Pacific, however, demonstrates the fastest growth, compounding at a CAGR of 6% from 2023 to 2030 (source: GlobalData).

Financial Trajectory

• Current Sales: BROMDAY's sales are modest, estimated between USD 10–20 million annually, primarily driven by local pharmaceutical distributors.

• Revenue Growth Potential:

  • Market expansion prospects hinge on regional approval and a shift in prescribing habits.
  • Absence of patent exclusivity constrains premium pricing.
  • Introduction into new markets via licensing or regulatory approval could increase sales by 50–200% over five years if favorable market conditions are achieved.

• R&D and Marketing Expenses: Minimal for generic or mature formulations; strategic investment could include marketing in obstinate markets or formulation innovations.

Key Factors Influencing Financial Trajectory

1. Regulatory approvals in new regions. Approvals could expand access and sales; delays or rejections limit growth.
2. Market acceptance amid emerging competition and regulatory scrutiny. Shifts to non-benzodiazepines may reduce prescribing.
3. Pricing strategies amid generic competition. Lower prices could maintain volume but reduce profitability.
4. Product line extensions or formulations. Extended-release or combination products could command higher prices.

Risks and Opportunities

Risks	Opportunities
Regulatory restrictions on benzodiazepines	Expand into markets with high demand for anxiolytics
Increasing cultural awareness of abuse potential	Develop formulations with lower dependency risks
Competition from non-benzodiazepine drugs	Diversify into new indications like sleep disorders

Summary

BROMDAY's market remains niche, primarily driven by regional approvals and existing benzodiazepine demand. Revenue prospects depend on regulatory expansion, market acceptance, and competition dynamics. The potential for growth exists but is constrained by patent expiration, competitive pressures, and evolving prescribing behaviors.

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Key Takeaways

• BROMDAY sales are approximately USD 10–20 million annually, with limited growth outside regional markets.
• Patent expiry and market saturation restrict pricing power; future growth relies on geographic expansion and formulation innovation.
• Regulatory approval in new regions could boost sales by up to 200% over five years.
• Market shifts toward non-addictive therapies pose long-term risks.
• The global anxiolytic market is expected to grow at a CAGR of 5–6%, primarily in emerging markets.

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FAQs

1. What factors influence BROMDAY's sales growth?
Regulatory approvals, competition from generic benzodiazepines, prescriber preferences, and market demand fluctuations influence sales.

2. How does patent expiry affect BROMDAY's financial prospects?
Patent expiration allows generic manufacturers to produce cheaper versions, reducing BROMDAY's market share and profit margins.

3. Are there opportunities for BROMDAY in the sleep disorder market?
Potential exists for off-label use or formulations targeting sleep disorders, which could expand revenue streams.

4. What are the primary risks associated with investing in BROMDAY?
Regulatory restrictions, declining demand due to safety concerns with benzodiazepines, and aggressive generic competition.

5. How does regional market size impact BROMDAY's outlook?
Regions with high anxiety prevalence and limited access to newer therapies present growth opportunities, notably in Asia and Middle East.

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References

[1] GlobalData, "Global anxiolytic drugs market report," 2022.