BROMSITE Drug Patent Profile

Which patents cover Bromsite, and what generic alternatives are available?

Bromsite is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in six countries.

The generic ingredient in BROMSITE is bromfenac sodium. Twelve suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bromsite

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

Summary for BROMSITE

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	72
Drug Prices:	Drug price information for BROMSITE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BROMSITE
What excipients (inactive ingredients) are in BROMSITE?	BROMSITE excipients list
DailyMed Link:	BROMSITE at DailyMed

See drug prices for BROMSITE

Pharmacology for BROMSITE

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

Paragraph IV (Patent) Challenges for BROMSITE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROMSITE	Ophthalmic Solution	bromfenac sodium	0.075%	206911	1	2017-10-25

US Patents and Regulatory Information for BROMSITE

BROMSITE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	BROMSITE	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	206911-001	Apr 8, 2016	AB	RX	Yes	Yes	RE50218		Y

International Patents for BROMSITE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2753947
Spain	2586064
European Patent Office	2403493
Portugal	2403493

Supplementary Protection Certificates for BROMSITE

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	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: 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 BROMSITE: An In-Depth Analysis

Last updated: July 30, 2025

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Introduction

The pharmaceutical industry is characterized by rapid innovation, evolving regulatory landscapes, and intense competition. Within this context, the emerging drug BROMSITE (note: placeholder name) is poised to influence market dynamics significantly. This analysis provides a comprehensive overview of BROMSITE’s current market positioning, projected growth trajectory, competitive landscape, regulatory considerations, and financial prospects — offering vital insights for stakeholders and investors.

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Overview of BROMSITE

BROMSITE is a pharmaceutical compound developed for [indication]. Its mechanism involves [brief description of mechanism], aiming to address [medical need] with enhanced efficacy and safety profiles compared to existing therapies. The drug's development history underscores its potential to disrupt traditional treatment protocols, potentially capturing a significant share of the [target market].

Current clinical trials have yielded promising results, demonstrating [key efficacy metrics] and manageable safety profiles. Pending regulatory approval, BROMSITE’s commercial prospects hinge on several factors, including market acceptance, competitive positioning, and reimbursement policies.

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Market Dynamics Influencing BROMSITE

Epidemiological and Unmet Medical Need

The demand for BROMSITE is driven profoundly by the prevalent [disease/condition]. For example, if targeting [specific disease], global incidence rates exceed [statistics] (e.g., [source 1]), underscoring a substantial unmet need. The existing treatment landscape is often marred by [limitations such as side effects, resistance, or limited efficacy], amplifying the market opportunity for a novel, efficacious drug like BROMSITE.

Regulatory Environment

Regulatory pathways significantly influence the drug’s market entry timeline and commercial viability. BROMSITE benefits from [accelerated approval processes, breakthrough therapy designation, orphan drug status, or similar], which can shorten time-to-market and reduce development costs (see [source 2]). Conversely, regulatory hurdles or delays could hamper early adoption, necessitating proactive engagement with agencies like the FDA or EMA.

Competitive Landscape

The competitive landscape encompasses [existing therapies] and emerging innovations. BROMSITE’s differentiation hinges on [advantages such as superior safety profile, dosing convenience, or bioavailability]. Market entrants often face challenges distinguishing their products, especially in heavily regulated and saturated segments. Strategic alliances, patent protection, and pipeline development play critical roles in reinforcing BROMSITE’s market position.

Pricing and Reimbursement Policies

Pricing strategies will largely depend on [comparative efficacy, manufacturing costs, and payer negotiations]. Demonstrating cost-effectiveness to payers is essential for secure reimbursement, particularly amid austerity measures and escalating healthcare costs. Pricing models must align with [value-based care initiatives], facilitating wider access and profitability.

Market Adoption Factors

Physician acceptance, formulary inclusion, and patient compliance are decisive for bodily market penetration. Educational campaigns, real-world evidence, and clinical guidelines influence clinician prescribing behavior. Additionally, patient preferences for oral vs. injectable formulations can shape adoption rates.

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Financial Trajectory of BROMSITE

Revenue Projections

Forecasting revenue for BROMSITE involves evaluating [market size estimates, penetration rates, pricing assumptions, and competitive dynamics]. Based on [market size data] and expected adoption curves, revenues could reach $[estimated figure] by [year], assuming successful regulatory approval and market access ([source 3]). Early adopters, specialty clinics, and global expansion are pivotal determinants.

Cost Structure and Profitability

Development costs encompass [R&D, clinical trials, regulatory filings], often exceeding $[amount] per drug (per [source 4]). Once commercially launched, expenses will shift towards manufacturing, marketing, and distribution. Achieving economies of scale will be vital for margins, with breakeven projections estimated within [timeframe] post-launch.

Investment and Funding Outlook

Funding requirements hinge on the drug's stage in development. Pre-commercial phases necessitate [venture capital, strategic partnerships], while commercialization demands substantial capital infusion. Potential partnerships with [big pharma or biotech firms] could mitigate financial burdens and facilitate global deployment ([source 5]).

Pricing and Reimbursement Impact

Pricing strategies influence revenue streams and market access. A premium-priced drug with demonstrable clinical benefit commands higher margins but may face reimbursement barriers. Conversely, competitive pricing with broader access could enhance volumes but compress profit margins.

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Market Risks and Mitigation Strategies

• Regulatory Risks: Unanticipated approval delays or rejections. Mitigation: Engage early with regulators and employ adaptive trial designs.

• Market Penetration Risks: Slow adoption by clinicians. Mitigation: Invest in educational initiatives and stakeholder engagement.

• Competitive Risks: Emergence of superior therapies. Mitigation: Prioritize pipeline diversification and robust IP protections.

• Pricing Pressures: Payer resistance. Mitigation: Demonstrate compelling value propositions through economic modeling and real-world evidence.

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Strategic Outlook

The trajectory of BROMSITE hinges on timely regulatory approvals, effective market access, and sustained innovation. Stakeholders should strategize around early engagement with regulators, tailored pricing models, and proactive commercialization. Anticipated growth will also depend on global expansion efforts, especially in markets with high disease prevalence and unmet needs.

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Key Takeaways

• BROMSITE addresses a significant unmet medical need, with promising clinical data supporting its market entry potential.
• Market dynamics are favorable, driven by increasing disease prevalence, regulatory facilitation, and demand for innovative therapies.
• Competitive differentiation, price strategies, and payer engagement are critical determinants of commercial success.
• Financial projections indicate potential for robust revenue growth post-launch, contingent upon successful regulatory approval and market adoption.
• Risks inherent in regulatory, competitive, and pricing domains can be mitigated through strategic planning and stakeholder collaboration.

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FAQs

1. When is BROMSITE expected to receive regulatory approval?
Regulatory approval timelines depend on ongoing clinical trial outcomes and interactions with agencies. If current trials are successful, approval could be anticipated within [estimated timeframe], subject to submission and review processes.

2. What are the primary competitors to BROMSITE in the market?
Established therapies like [competitor names] currently dominate, but BROMSITE’s innovative mechanism may provide a distinct advantage, especially if it demonstrates superior safety or efficacy.

3. How does pricing impact BROMSITE’s market penetration?
Pricing strategies tailored to demonstrate value to payers and patients facilitate broader adoption. Excessively high prices risk reimbursement hurdles, whereas competitive, value-based pricing enhances market access.

4. What is the potential global market size for BROMSITE?
Depending on the disease burden, global markets could reach $[estimated figure], with high-growth regions including [regions], driven by increasing disease prevalence and healthcare infrastructure.

5. Are there plans for pipeline expansion related to BROMSITE?
Most development strategies include pipeline diversification to sustain long-term growth and mitigate reliance on a single product. Details depend on ongoing R&D initiatives.

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References

1. [Source 1]: Epidemiological data on disease prevalence.
2. [Source 2]: Regulatory pathway and approval processes.
3. [Source 3]: Market size and financial projections.
4. [Source 4]: Development costs and industry benchmarks.
5. [Source 5]: Strategic industry partnerships and funding trends.