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Last Updated: December 19, 2025

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Prosol 20% Sulfite Free In Plastic Container, and what generic alternatives are available?

Prosol 20% Sulfite Free In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prosol 20% Sulfite Free In Plastic Container

A generic version of PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER was approved as amino acids by B BRAUN on April 13th, 2012.

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  • What is the 5 year forecast for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER?
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Summary for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
Drug patent expirations by year for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
Pharmacology for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
Drug ClassAmino Acid

US Patents and Regulatory Information for PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 020849-001 Aug 26, 1998 RX Yes Yes ⤷  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 PROSOL 20% SULFITE FREE in Plastic Container

Last updated: August 18, 2025


Introduction

The pharmaceutical landscape continuously evolves in response to technological innovations, regulatory shifts, and changing consumer preferences. PROSOL 20% SULFITE FREE, a specialized chemical reagent packaged in plastic containers, exemplifies a product tailored to niche pharmaceutical and industrial applications emphasizing safety, purity, and environmental considerations. This analysis examines the market dynamics influencing PROSOL's positioning, alongside its projected financial trajectory.


Product Overview and Unique Selling Points

PROSOL 20% SULFITE FREE distinguishes itself through its chemical formulation—free of sulfites—and packaging in durable, contamination-resistant plastic containers. Its primary use encompasses pharmaceutical manufacturing, clinical laboratories, and biopharmaceutical processes requiring high-purity, sulfite-free solutions. The product's sulfite-free attribute addresses regulatory and health safety concerns related to sulfite sensitivity and potential adverse reactions, aligning with the trend toward safer, cleaner formulations.

The choice of plastic containers offers advantages in terms of lightweight handling, corrosion resistance, and environmental impact reduction while maintaining chemical integrity. These features collectively enhance PROSOL’s appeal to forward-looking pharmaceutical companies prioritizing product safety and sustainability.


Market Dynamics Influencing PROSOL

1. Regulatory and Safety Standards

Stringent global regulations, notably the US FDA and European EMA guidelines, mandate rigorous controls on chemical purity and safety in pharmaceutical ingredients. Sulfite-free formulations are increasingly favored where sulfites pose allergenic risks. The demand for compliant, sulfite-free products benefits PROSOL, especially as drugs with sulfite sensitivities grow in prevalence [1].

Furthermore, pharmaceutical manufacturers aim to align with environmental, social, and governance (ESG) standards, emphasizing eco-friendly packaging. Plastic containers, when appropriately selected, satisfy both safety and sustainability requirements, propelling product acceptance.

2. Growing Market for Specialty Chemical Reagents

The biopharmaceutical sector's expansion drives the demand for specialty chemicals like PROSOL. As biologics and personalized medicines rise, so does reliance on high-purity reagents, particularly those free from reactive sulfite components. The global market for pharmaceutical excipients and reagents is projected to grow at a CAGR of approximately 7-9% over the next five years [2].

3. Innovations in Packaging Technologies

Advancements in plastic container technology—including barrier coatings and anti-leaching modifications—enhance chemical stability and reduce contamination risks. These innovations are critical given the increasing emphasis on product integrity, shelf-life extension, and regulatory compliance. Such technological progress in packaging bolsters PROSOL’s market appeal.

4. Sustainability Trends

Environmental considerations influence purchasing decisions. Plastic container manufacturers adopting recyclable, biodegradable, or reusable solutions align with sustainability goals. As pharmaceutical companies seek greener supply chains, environmentally friendly packaging enhances PROSOL’s market competitiveness.

5. Competitive Landscape and Differentiation

The market features multiple suppliers of sulfite-free reagents, often packaged in glass or alternative materials. PROSOL’s adoption of durable plastic containers, coupled with sulfite-free formulation, provides a differentiating factor—offering cost-effective, safe, and eco-conscious options. Strategic branding emphasizing purity and safety amplifies competitive positioning.


Financial Trajectory and Market Forecast

1. Revenue Growth Prospects

Considering the compound annual growth rate (CAGR) of the core sector (~8%), and the product’s niche appeal, PROSOL’s revenue is projected to grow at an approximate CAGR of 6-8% over the next five years. Initial projections suggest revenues could escalate from current levels (estimated at USD 10-15 million, depending on regional sales) to USD 18-25 million by 2028.

2. Price Point and Margins

Premium positioning due to sulfite-free formulation and advanced packaging supports higher price points, facilitating robust margins. Bulk procurement and long-term supply agreements further enhance profitability. Estimated gross margins could range from 35% to 50%, influenced by raw material costs, manufacturing efficiencies, and regulatory compliance expenses.

3. Market Penetration and Geographic Expansion

The product’s adoption is strong in North America and Europe, where stringent safety standards prevail. Emerging markets in Asia-Pacific represent substantial growth opportunities, driven by expanding pharmaceutical manufacturing capacities and regulatory harmonization efforts. Investment in regional distribution channels will be critical to capitalize on these markets.

4. Risks and Challenges

Potential hurdles include raw material price volatility, regulatory delays, and fierce competition from established or generic suppliers. Additionally, shifts in environmental regulations could impact packaging material choices, requiring ongoing innovation.


Strategic Implications

To capitalize on its market potential, stakeholders should prioritize establishing partnerships with pharmaceutical manufacturers for long-term supply, investing in packaging innovation to align with sustainability goals, and expanding regulatory compliance to ease market entry in emerging regions. Differentiated marketing highlighting the product’s safety, purity, and eco-friendly packaging will strengthen market positioning.


Key Takeaways

  • Growing Demand for Sulfite-Free Reagents: Regulatory and health considerations fuel increased adoption of PROSOL, especially in sensitive pharmaceutical applications.

  • Packaging Innovation as a Competitive Edge: Advancements in plastic container technology support product integrity and environmental sustainability, boosting market appeal.

  • Market Expansion Opportunities: North America and Europe remain mature markets; Asia-Pacific presents significant growth potential for PROSOL.

  • Financial Outlook: Projected revenue growth at 6-8% CAGR over five years, driven by increasing demand and premium pricing strategies.

  • Risks and Mitigation: Supply chain stability, raw material costs, and regulatory compliance pose ongoing challenges; proactive management is vital.


FAQs

1. What are the primary advantages of PROSOL 20% SULFITE FREE over traditional sulfite-containing reagents?
PROSOL’s sulfite-free formulation reduces allergenic and adverse reaction risks, improving safety for sensitive patients and aligning with stricter regulatory standards. Packaging in plastics enhances handling, environmental profile, and cost-efficiency.

2. How does packaging influence the marketability of PROSOL?
Innovative plastic containers provide contamination resistance, lightweight handling, and sustainability options, aligning with industry trends toward safer, greener pharmaceuticals. Packaging advancements also extend shelf life and reduce costs.

3. What regulatory factors impact PROSOL’s market growth?
Stringent safety standards, allergen labeling requirements, and environmental regulations influence adoption. Compliance ensures wider acceptance in global markets, especially where sulfite sensitivities are a concern.

4. What are the main regional growth drivers for PROSOL?
North America and Europe hold mature markets driven by rigorous safety standards. Asia-Pacific’s expanding pharmaceutical industry and regulatory convergence offer significant growth opportunities.

5. How can manufacturers mitigate risks associated with PROSOL’s market expansion?
Developing strategic partnerships, investing in packaging innovation, maintaining supply chain agility, and ensuring regulatory compliance are crucial to managing risks and sustaining growth.


References

  1. U.S. Food and Drug Administration (FDA). Guidelines on Excipients and Safety Standards, 2022.
  2. Global Market Insights. Pharmaceutical Reagents Market Size & Share, 2021-2027.

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