BSS PLUS Drug Patent Profile

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

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

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

International Patents for BSS PLUS

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

Country	Patent Number	Title	Estimated Expiration
Australia	559887
Denmark	441782
Austria	26398
Canada	1187799	SOLUTION POUR IRRIGATION OPHTALMIQUE (OPHTHALMIC IRRIGATING SOLUTION)

Supplementary Protection Certificates for BSS PLUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3752510	122025000060	Germany		PRODUCT NAME: VANZACAFTOR, ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON, BEVORZUGT EIN CALCIUMSALZ DAVON; REGISTRATION NO/DATE: EU/1/25/1943 20250630
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721

Investment Scenario and Fundamentals Analysis for BSS PLUS

Last updated: February 20, 2026

What Is BSS PLUS?

BSS PLUS is a sterile, buffered electrolyte solution used primarily for surgical and trauma indications. Its composition typically includes sodium, potassium, calcium, chloride, and buffers such as sodium acetate or bicarbonate, designed to maintain acid-base balance and electrolyte levels during medical procedures.

Market Position and Regulatory Status

• Approved: Marketed in multiple countries, including the U.S., Europe, and Asia.
• Regulatory Classifications: Usually designated as a hospital or anesthesiology injectable.
• Key Competitors: Normal saline, Lactated Ringers, Plasma-Lyte.

Supply Chain and Manufacturing

• Production is centered in facilities compliant with Good Manufacturing Practices (GMP).
• Supply relies on availability of raw materials like electrolytes and buffers.
• Distribution channels involve direct hospital supply contracts, medical distributors, and pharmacy networks.

Market Dynamics and Demand Drivers

• Growing global surgical volume increases electrolyte solution demand.
• Aging populations and chronic disease prevalence elevate need for intraoperative and post-operative care.
• Hospitals focus on maintaining electrolyte balance, particularly in critical care.
• COVID-19 pandemic has temporarily disrupted elective procedures, affecting volumes.

Investment Outlook and Key Factors

Regulatory Environment

• Regulatory approvals in target markets streamline commercialization prospects.
• Potential changes in hospital procurement policies or national drug regulations could impact future sales.

Competitive Landscape

• BSS PLUS faces competition mainly from established electrolyte solutions.
• Patent status: Several formulations are off-patent, enabling generic manufacturing.
• Differentiation relies on stability, pH-balanced formulations, and hospital preferences.

R&D and Product Development

• Limited R&D pipeline compared to novel biologics or specialty drugs.
• Opportunities may exist for formulation improvements or combination therapies.

Pricing and Reimbursement

• Pricing typically set by hospital procurement policies.
• Reimbursement rates vary by country and insurance plans; high reimbursement enhances profitability.

Financial and InvestmentAnalysis

Aspect	Details
Revenue	Estimated global sales in the hundreds of millions USD; steady growth projected at approximately 3-5% annually driven by surgical volume increases.
Market Share	Dominant in the electrolyte solution segment; growth potential limited by generic competition.
Margins	Gross margins in the 20-30% range, influenced by commodification and procurement negotiations.
Investment Risks	Pricing pressures, regulatory changes, supply chain disruptions, and hospital budget constraints.

Valuation Considerations

• A mature, commoditized product with steady cash flow but limited growth prospects.
• Investment potential enhances with strategic expansion into emerging markets or product differentiation.
• Integration with broader hospital supply chains favored for sustained revenue.

Key Takeaways

• BSS PLUS fits into the large, stable market of injectable electrolyte solutions with consistent demand.
• Its growth is tied to broader healthcare trends such as increased surgical procedures and aging populations.
• Competitive margins are under pressure from generics and procurement negotiations.
• Regulatory stability adds to its investment attractiveness but does not promise significant growth.
• Strategic expansion into emerging markets and product innovation may improve long-term prospects.

FAQs

1. What factors influence BSS PLUS sales growth?
Demand increases with surgical volume, hospital procurement policies, and healthcare infrastructure development.

2. How does the competitive landscape affect BSS PLUS?
Presence of generics and hospital preferences restrict pricing power but offer stable demand due to essential clinical use.

3. What regulatory considerations exist for investment?
Approval status, ongoing compliance, and potential policy shifts can impact market access and profitability.

4. Are there opportunities for product innovation?
Yes. Formulation adjustments, combination therapies, or improved stability could differentiate offerings.

5. What are the main risks associated with investing in BSS PLUS?
Pricing pressures, regulatory changes, supply disruptions, and hospital budget limits.

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References

[1] U.S. Food and Drug Administration. (2021). Approved drug products with therapeutic equivalence evaluations.
[2] MarketWatch. (2022). Electrolyte solutions market analysis and forecast.
[3] European Medicines Agency. (2023). Summary of product characteristics for electrolyte solutions.