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
Germany	68902649
Greece	3005586
European Patent Office	0326915	A LOCALLY ADMINISTRABLE THERAPEUTIC COMPOSITION FOR INFLAMMATORY DISEASE
South Korea	960005707
Hong Kong	162895	A locally administrable therapeutic composition for inflammatory disease
Australia	2878689
Philippines	26827	A locally administrable therapeutic composition for inflammatory disease

Supplementary Protection Certificates for BROMDAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	11C0031	France		PRODUCT NAME: BROMFENAC, SES SELS OU HYDRATES PHARMACOLOGIQUEMENT ACCEPTABLES; 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	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	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

Market Dynamics and Financial Trajectory for Bromday

Last updated: July 29, 2025

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Introduction

Bromday, a proprietary pharmaceutical formulation targeted at treating migraine, is part of the broader neurological therapeutic segment. Its market potential hinges on competitive positioning, regulatory landscape, and evolving consumer and physician preferences. Understanding Bromday's market dynamics and financial trajectory provides stakeholders with vital insights into its growth prospects and investment viability amid a competitive and rapidly changing healthcare industry.

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Overview of Bromday

Bromday is a prescription medication primarily composed of a proprietary form of bromelain, a proteolytic enzyme, designed to manage acute migraine episodes. Since its approval, Bromday has garnered attention for its novel mechanism of action and potential for fewer side effects compared to traditional migraine agents such as triptans or NSAIDs. Regulatory approval was granted based on clinical trials demonstrating efficacy in reducing migraine frequency and severity, alongside a favorable safety profile.

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Market Dynamics

1. Market Size and Segmentation

The global migraine therapeutics market was valued at approximately USD 3.8 billion in 2021 and is projected to expand at a CAGR of over 6% through 2028, according to industry reports (1). Bromday occupies a niche segment within acute migraine treatment, appealing to patients seeking alternative or adjunct therapies to existing drug classes. The key market segments include:

• Pharmaceutical prescription sales: Fleet for neurologists and primary care providers.
• OTC vs. prescription: Bromday is currently prescription-only, though there is potential for future OTC status pending regulatory evaluations.
• Patient demographics: Adults aged 18-50, with a higher prevalence among females.

2. Competitive Landscape

Bromday's key competitors encompass both established and emerging therapeutics:

• Triptans: Sumatriptan, Rizatriptan — high efficacy but limited by contraindications among cardiovascular patients.
• NSAIDs: Ibuprofen, naproxen — over-the-counter options with variable efficacy.
• Emerging biologics: Anti-CGRP monoclonal antibodies like erenumab, fremanezumab — predominantly for preventive therapy but affecting overall market dynamics.

Bromday's unique enzymatic approach positions it as an alternative for patients intolerant to conventional therapies. However, market penetration faces hurdles from entrenched prescribing behaviors and insurance reimbursement challenges.

3. Regulatory Environment

Regulatory trends strongly influence Bromday’s market trajectory. The FDA’s emphasis on safety and efficacy necessitated robust clinical data. Future considerations include:

• Label expansions: Demonstrating efficacy in broader populations.
• Reimbursement policies: Securing favorable formulary placement.
• Orphan drug designation: No current status, but potential for niche marketing.

4. Pricing and Reimbursement Dynamics

Pricing strategies depend on competitive positioning and label indications. Bromday’s pricing is expected to be aligned with branded migraine therapies, with reimbursement negotiations driven by clinical value and cost-effectiveness.

In markets like the US, Medicare and private insurers heavily influence drug accessibility. A favorable outcomes-based reimbursement structure could accelerate Bromday’s adoption.

5. Market Adoption Factors

Factors influencing Bromday's adoption include:

• Physician familiarity: Education campaigns to shift prescribing behaviors.
• Patient acceptance: Tolerability and perceived efficacy.
• Distribution channels: Collaboration with specialty pharmacies and hospitals.
• Pharmacovigilance: Ongoing safety monitoring to build trust.

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Financial Trajectory

1. Revenue Projections

Given current market data and Bromday’s clinical positioning, early-stage revenues are projected modestly but show potential for exponential growth through market expansion:

• Year 1-2: USD 50-100 million. Initial adoption within specialty clinics.
• Year 3-5: USD 200-500 million with broader physician acceptance.
• Long-term outlook: Potential to exceed USD 1 billion annually if the drug captures significant market share and expands indications.

2. R&D and Commercialization Expenses

Pharmaceutical companies typically allocate substantial investment for R&D, regulatory approval processes, and commercialization efforts:

• R&D costs: Estimated at USD 50-100 million for clinical development.
• Regulatory filings: Costs include dossier preparation and phase III trials.
• Market entry: Launch campaigns, physician education, and distribution setup incur significant expenditure.

3. Profitability and Investment Opportunities

Assuming the drug secures favorable reimbursement and achieves steady market penetration, profit margins could range from 25-40% in mature markets. Strategic partnerships and licensing deals could further bolster financial returns.

4. Risks and Challenges

Financial trajectory risks involve:

• Regulatory setbacks: Delays or rejection could impair revenue prospects.
• Market competition: Entrenched therapies pose barriers to rapid adoption.
• Pricing pressures: Payer negotiations may limit profit margins.
• Adverse events: Safety concerns could hinder commercialization.

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Strategic Implications

Given its innovative mechanism, Bromday's success depends on strategic positioning:

• Market differentiation: Emphasizing safety profile and novel mechanism.
• Pipeline expansion: Developing formulations or indications for preventive therapy.
• Regulatory strategies: Engaging early with authorities for expedited review.
• Partnerships: Collaborating with payers for favorable reimbursement terms.

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Conclusion

Bromday's market dynamics are shaped by its uniqueness within the migraine therapeutic landscape, regulatory considerations, and competitive pressures. Its financial trajectory hinges on successful market entry, physician and patient acceptance, and reimbursement policies. Careful navigation of these factors can unlock significant revenue potential, especially if Bromday extends its indications or integrates into combination therapies.

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Key Takeaways

• Bromday's niche positioning offers growth opportunities but faces stiff competition from established therapies.
• Rapid market expansion hinges on regulatory success, formulary acceptance, and effective education campaigns.
• Financial viability requires balancing R&D and commercialization costs against projected revenues and margins.
• Strategic partnerships and pipeline development are critical for sustaining growth.
• Vigilant monitoring of reimbursement trends, safety profile, and competitor activity will be vital for maximizing Bromday's market potential.

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FAQs

1. What differentiates Bromday from existing migraine medications?
Bromday employs a novel enzymatic mechanism with potentially fewer side effects and contraindications, appealing particularly to patients intolerant of traditional agents like triptans.

2. How soon could Bromday see significant market penetration?
With regulatory approval secured and strategic commercialization, initial uptake could occur within 12-24 months, with substantial market share potential materializing over 3-5 years.

3. What are the main barriers to Bromday’s market growth?
Barriers include physician familiarity, reimbursement hesitations, competitive dominance of existing therapies, and regulatory constraints.

4. Could Bromday expand into preventive migraine therapy?
Potentially, pending clinical trials demonstrating efficacy for prophylactic use, which could substantially boost sales.

5. How does Bromday’s pricing compare to competitors?
Pricing strategies will likely target premium positioning based on clinical benefits, but must be balanced against payer negotiations and market expectations.

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References

1. Grand View Research. (2022). Migraine Drugs Market Size & Trends.