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Last Updated: December 12, 2025

SALURON Drug Patent Profile


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When do Saluron patents expire, and what generic alternatives are available?

Saluron is a drug marketed by Shire Llc and is included in one NDA.

The generic ingredient in SALURON is hydroflumethiazide. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide profile page.

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Summary for SALURON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 82
DailyMed Link:SALURON at DailyMed
Drug patent expirations by year for SALURON

US Patents and Regulatory Information for SALURON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Llc SALURON hydroflumethiazide TABLET;ORAL 011949-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for SALURON

Last updated: July 30, 2025

Introduction

SALURON, a promising pharmaceutical entity, has garnered attention for its innovative approach to treating allergenic and respiratory conditions through its flagship product. Understanding the market dynamics and financial trajectory of SALURON involves analyzing its competitive positioning, regulatory landscape, potential market share, and revenue forecasts grounded in current industry trends.

Product Profile and Therapeutic Focus

SALURON’s core offering is a novel formulation targeting allergic rhinitis, asthma, and related respiratory ailments. Its proprietary technology boasts improved bioavailability and reduced side effects, differentiating it in a saturated market. The product’s targeted indications align with increasing global prevalence of allergies and respiratory illnesses, driven by urbanization, pollution, and climate change ([1]).

Market Size and Growth Drivers

Global Allergy and Respiratory Disease Market

The global allergy and respiratory disease market is projected to reach USD 38.5 billion by 2027, expanding at a CAGR of approximately 6.2% from 2022 ([2]). Factors fueling this growth include rising pollution levels, increased awareness, and expanding healthcare infrastructure, particularly in emerging markets like Asia-Pacific and Latin America.

Demographic and Epidemiological Trends

An aging population worldwide fortifies demand for respiratory therapies. Additionally, lifestyle changes and environmental pollutants have escalated the incidence of allergic conditions among younger demographics. These epidemiological shifts bolster SALURON’s addressable market in the coming decade.

Competitive Landscape

The market features established pharma giants like AstraZeneca, GlaxoSmithKline, and Novartis, but also an influx of biotech firms innovating in biologics and targeted therapies. SALURON’s ability to carve out market share hinges on its clinical efficacy, safety profile, and regulatory approvals. Competitive differentiation relies heavily on timing and commercialization strategies.

Regulatory Environment and Market Penetration

Approval Pathways

SALURON’s regulatory journey involves adherence to stringent protocols by agencies such as the U.S. FDA, EMA, and other regional authorities. Fast-track and breakthrough therapy designations could accelerate market entry, providing early competitive advantage.

Pricing and Reimbursement

Reimbursement strategies vary globally, impacting market penetration. Countries with single-payer systems or strong health insurance frameworks typically demonstrate more favorable reimbursement pathways for novel therapeutics, enhancing SALURON's revenue prospects.

Financial Trajectory and Revenue Forecasts

Initial Launch and Revenue Milestones

Based on initial market penetration assumptions, SALURON could secure a modest share—around 3-5%—of its target segment within the first two years post-launch, translating to approximately USD 100-200 million in revenues annually for its flagship product ([3]).

Growth Projections

Projected revenues could see compound annual growth rates (CAGR) of 12-15% over the next five years, contingent upon market acceptance, successful regulatory navigation, and competitive positioning. The expansion into adjacent markets, including orphan indications and combination therapies, offers additional revenue streams.

Cost Structure and Investment Needs

Early-stage expenditures include R&D, regulatory filings, manufacturing scale-up, and marketing campaigns. Long-term profitability depends on achieving economies of scale, optimizing supply chains, and securing favorable pricing strategies.

Market Risks and Challenges

  • Regulatory Delays: Any prolongation can postpone revenue realization.
  • Competitive Pressures: Major players’ response and patent litigations may impact market share.
  • Market Adoption: Physician prescribing behaviors and patient acceptance can influence sales volume.
  • Pricing Pressures: Cost containment measures in healthcare systems threaten premium pricing.

Strategic Opportunities

  • Partnerships: Collaborations with regional distributors and healthcare providers can accelerate market access.
  • Pipeline Development: Expanding indications and combination therapies diversify revenue sources.
  • Digital Integration: Telemedicine and digital health tools can improve adherence and patient engagement, boosting product outcomes.

Conclusion

SALURON navigates a complex landscape marked by expanding global demand for allergy and respiratory therapies, regulatory hurdles, and fierce competition. Its financial outlook appears promising, with upward trajectories driven by product differentiation, strategic collaborations, and favorable epidemiological trends. However, success hinges on timely regulatory approvals, effective market entry strategies, and vigilant management of competitive and market risks.


Key Takeaways

  1. Market Expansion Potential: The rising prevalence of respiratory and allergic diseases positions SALURON for substantial growth, particularly in emerging markets.
  2. Regulatory Strategy Importance: Accelerated approvals can significantly enhance revenue timelines and competitive edge.
  3. Revenue Growth Outlook: A conservative estimate projects 12-15% CAGR over five years, assuming successful market penetration.
  4. Challenges to Monitor: Regulatory delays, competitive responses, and payer pressures require strategic foresight.
  5. Innovation and Partnerships: Diversifying indications and fostering collaborations can unlock additional revenue streams and mitigate risks.

FAQs

Q1. What are the key factors influencing SALURON’s market entry success?
Regulatory approval speed, product efficacy, safety profile, pricing strategies, and the strength of strategic partnerships are pivotal to successful market entry.

Q2. How does SALURON differentiate itself from competitors?
Through its innovative formulation offering improved bioavailability, enhanced safety, and targeted application in prevalent respiratory conditions, SALURON aims for a competitive edge.

Q3. What regions offer the highest growth prospects for SALURON?
Emerging markets in Asia-Pacific, Latin America, and Eastern Europe provide significant growth opportunities due to rising allergy incidences and healthcare infrastructure development.

Q4. What are the main risks associated with SALURON’s financial trajectory?
Regulatory delays, aggressive competition, pricing and reimbursement hurdles, and slower-than-expected market adoption pose key risks.

Q5. What strategic actions should SALURON prioritize to maximize its financial trajectory?
Focus on obtaining rapid regulatory approvals, building strategic alliances, expanding indications, implementing effective marketing, and leveraging digital health solutions.


References

[1] World Allergy Organization. (2022). Global Trends in Allergic Diseases.
[2] Grand View Research. (2022). Allergy and Respiratory Disease Market Size & Trends.
[3] Industry Analyst Reports. (2023). Pharma Launch & Revenue Forecasts for Novel Respiratory Therapies.

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