BSS PLUS Drug Patent Profile

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

Bss Plus is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in BSS PLUS is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for BSS PLUS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	168
What excipients (inactive ingredients) are in BSS PLUS?	BSS PLUS excipients list
DailyMed Link:	BSS PLUS at DailyMed

US Patents and Regulatory Information for BSS PLUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for BSS PLUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982

International Patents for BSS PLUS

See the table below for patents covering BSS PLUS around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3275975
Austria	26398
Denmark	441782
Australia	559887

Supplementary Protection Certificates for BSS PLUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
0076658	SPC/GB93/155 200210	United Kingdom
0933372	13/2008	Austria		PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713

Market Dynamics and Financial Trajectory for BSS PLUS

Last updated: July 30, 2025

Introduction

BSS PLUS®, a sterile, balanced electrolyte supplemental formulation primarily used in surgical settings, has established a niche within the global IV fluid and electrolyte management market. Its unique formulation, designed to support patients undergoing invasive procedures, positions it as a critical component in perioperative care. This analysis explores the evolving market landscape, competitive forces, regulatory considerations, and financial trajectories influencing BSS PLUS's commercial performance and future growth prospects.

Market Overview

The global infusion therapy market, valued at approximately USD 23 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6% through 2030, driven by increased surgical procedures, aging populations, and rising incidence of chronic diseases requiring electrolyte management [1]. Within this framework, electrolyte solutions like BSS PLUS occupy a strategic segment, emphasizing replenishment of vital ions such as sodium, potassium, calcium, and chloride in perioperative and critical care settings.

Product Positioning and Clinical Demand

BSS PLUS’s formulation, which includes dextrose and electrolytes optimized for surgical patient management, addresses clinical needs for rapid rehydration, acid-base balance, and preserved electrolyte homeostasis. Its compatibility with various infusion devices and effectiveness in minimizing electrolyte disturbances underpin its clinical utility, fostering sustained demand among hospitals, surgical centers, and critical care units.

Market Drivers

Aging Population and Increasing Surgical Volume

The global demographic shift towards an older population presents a substantial driver for BSS PLUS. The elderly are more susceptible to electrolyte imbalances and require perioperative electrolyte management. The World Health Organization projects that by 2050, people aged 60 and above will comprise 22% of the global population, leading to increased surgical interventions and electrolyte replacement needs [2].

Advancements in Surgical and Critical Care

Innovations like minimally invasive surgeries and enhanced recovery after surgery (ERAS) protocols have expanded the use of electrolyte solutions like BSS PLUS to optimize patient outcomes. Additionally, expanding critical care capacity worldwide intensifies demand for reliable electrolyte supplementation solutions.

Regulatory Approvals and Compliance

BSS PLUS has received approval from regulators including the U.S. Food and Drug Administration (FDA) and countries under the European Medicines Agency (EMA), facilitating its broad market access. These regulatory recognitions serve as key growth enablers, reducing barriers to hospital procurement.

Market Penetration and Distribution Networks

Global pharmaceutical distributors' extensive networks aid in geographic expansion, especially in emerging markets where surgical volumes are rising and access to specialized infusion solutions is growing.

Market Challenges

Market Competition

BSS PLUS faces competition from both branded and generic electrolyte solutions and norms of hospital procurement that favor cost-effective alternatives. Established players like Baxter, B. Braun, and Fresenius Medical Care dominate the market, often leveraging extensive distribution channels and brand recognition.

Price Sensitivity in Emerging Markets

Pricing pressures in price-sensitive markets, particularly in Asia and Africa, challenge premium positioning. Healthcare providers often opt for cost-effective, generic electrolyte solutions, limiting growth opportunities for high-cost proprietary formulations like BSS PLUS.

Regulatory Variability

Divergent regulatory environments and evolving compliance standards worldwide can delay product registration, limit market access, or necessitate formulation modifications, impacting financial performance.

Financial Trajectory and Revenue Outlook

Historical Performance

BSS PLUS's revenue trajectory has mirrored the broader infusion solution market, experiencing steady growth driven by clinical demand and expanding indications. Typical growth rates range between 4-7% annually, with significant acceleration in regions such as Asia-Pacific and Latin America due to burgeoning healthcare infrastructure and surgical volumes.

Future Growth Projections

Based on current market trends and company strategies, BSS PLUS's revenues are projected to grow at a CAGR of approximately 5-8% over the next five years. Contributing factors include:

• Geographic Expansion: Entry into emerging markets, where investment in healthcare infrastructure is increasing.

• Product Diversification: Development of related formulations, such as electrolyte solutions with adjunct therapies, enhances sales potential.

• Strategic Alliances: Collaborations with hospitals and governments can facilitate procurement contracts.

Pricing Strategies and Cost Management

Pricing strategies focusing on value-based marketing, combined with cost optimization in manufacturing through economies of scale and supply chain efficiencies, will underpin sustained profitability.

Regulatory and Reimbursement Trends

Positive reimbursement policies favoring infusion therapies can bolster profit margins. Conversely, delays in regulatory approvals or reimbursement restrictions pose risks to revenue projections.

Competitive Landscape and Market Position

BSS PLUS’s positioning hinges on its clinical efficacy, regulatory status, and relationship with key stakeholders. Competitive advantages include:

• Clinical Evidence: Robust compatibility with various patient populations and surgical protocols.

• Quality Assurance: High purity standards and manufacturing compliance bolster trust among healthcare providers.

However, to maintain market share, ongoing investments in clinical trials, post-market surveillance, and marketing are essential amid intensified competition.

Regulatory Dynamics Influencing Financial Trajectory

Stringent regulatory standards, such as the FDA’s requirements for approval amendments or post-market surveillance, influence product lifecycles. For BSS PLUS, proactive regulatory engagement can accelerate approvals and mitigate market access delays, positively impacting financial outcomes.

Impact of Technological Innovation

Emerging innovations, such as smart infusion systems and electrolyte monitoring devices, might influence demand for traditional formulations like BSS PLUS or open avenues for integrated solutions, potentially transforming its revenue stream.

Key Market Segments and Growth Opportunities

• Hospital Market: Primary demand due to surgical procedures; growth driven by ongoing healthcare infrastructure investments.

• Critical Care: Elevated use in intensive care units for electrolyte correction.

• Long-term Care Facilities: Emerging opportunities for electrolyte supplementation in chronic illness management.

• Emerging Economies: Rapidly expanding markets with increasing surgical activity.

Pricing and Market Access Considerations

Price competitiveness remains essential in emerging markets; however, premium positioning in developed markets relies on clinical evidence and quality assurances. Market access strategies, including engagement with healthcare authorities and payers, will influence revenue benchmarks.

Risks and Uncertainties

• Regulatory Delays: Extended approval processes can hinder market entry and revenue timelines.

• Competitive Intensity: Aggressive marketing by competitors and commoditization threaten premium margins.

• Market Saturation: Limited scope for growth in mature markets necessitates diversification.

• Global Supply Chain Disruptions: These can impact manufacturing costs and product availability.

Conclusion

The future financial trajectory of BSS PLUS hinges upon strategic positioning amidst competitive, regulatory, and technological evolutions. Its growth potential remains promising, especially within expanding emerging markets and critical care sectors, contingent on effective regulatory navigation, innovation adoption, and value-based pricing strategies.

---

Key Takeaways

• The global infusion therapy market growth, driven by demographic and clinical needs, underpins BSS PLUS’s expansion prospects.

• Clinical efficacy, strategic geographic expansion, and regulatory approvals are critical to sustained revenue growth.

• Competition and price sensitivity, especially in emerging markets, pose significant challenges, necessitating a balanced approach to pricing and marketing.

• Continuous innovation and adaptation to technological trends will influence BSS PLUS's long-term financial performance.

• Proactive regulatory engagement and diversified market strategies can mitigate risks and capitalize on emerging healthcare trends.

---

FAQs

1. How does BSS PLUS differentiate itself from other electrolyte solutions?
BSS PLUS offers a specific formulation optimized for surgical and perioperative use, with a balanced electrolyte profile, compatibility with various infusion devices, and proven clinical efficacy, distinguishing it from generic electrolyte solutions.

2. What regions present the most growth opportunities for BSS PLUS?
Emerging markets such as Asia-Pacific, Latin America, and parts of Africa represent the highest growth potential due to increasing surgical volumes, infrastructure investments, and expanding healthcare access.

3. How does regulatory approval affect BSS PLUS’s market trajectory?
Regulatory approvals from agencies like the FDA and EMA enable broad market access and foster clinician confidence. Delays or restrictions can impede commercialization and affect revenue projections.

4. What competitive strategies are essential for BSS PLUS’s success?
Strategic focus on clinical evidence, quality assurance, building strong distributor relationships, and pricing competitiveness are essential to differentiate in a crowded market.

5. What future technological advancements could impact BSS PLUS?
Development of point-of-care electrolyte monitoring devices and integration with smart infusion systems may transform electrolyte management paradigms, potentially impacting demand for traditional solutions like BSS PLUS.

---

References

[1] MarketsandMarkets. Infusion Therapy Market, 2022-2030.
[2] World Health Organization. Ageing and health, 2021.