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Last Updated: December 16, 2025

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Drug Patent Profile


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When do Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride patents expire, and what generic alternatives are available?

Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride is a drug marketed by Extrovis, Novel Labs Inc, Solis Pharms, and Strides Pharma. and is included in four NDAs.

The generic ingredient in PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

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Summary for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Drug patent expirations by year for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Recent Clinical Trials for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nextrast, Inc.PHASE1
Shiyou WeiNA
Shanghai East Hospital of Tongji UniversityNA

See all PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE clinical trials

US Patents and Regulatory Information for PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Extrovis PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 090409-001 Apr 2, 2010 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 204559-001 Apr 13, 2015 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Novel Labs Inc PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 090019-001 May 27, 2009 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Solis Pharms PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 202060-001 Mar 8, 2017 DISCN No 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 the Pharmaceutical Drugs: PEG-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Last updated: November 8, 2025


Introduction

The pharmaceutical landscape for electrolyte solutions and laxatives—specifically PEG-3350, potassium chloride, sodium bicarbonate, and sodium chloride—has experienced significant evolution driven by clinical needs, regulatory shifts, manufacturing innovations, and healthcare policies. These compounds serve vital roles in gastrointestinal management, electrolyte replenishment, and acid-base correction, underpinning their sustained demand across hospitals, clinics, and home care settings.

This analysis explores the current market dynamics, growth drivers, challenges, and financial trajectories shaping these drugs, offering actionable insights for stakeholders and investors.


Market Overview and Segment-specific Analysis

Polyethylene Glycol 3350 (PEG-3350)

PEG-3350 is a non-absorbable osmotic laxative widely prescribed for chronic constipation and bowel preparation. Its patent expiration, coupled with over-the-counter (OTC) availability, has facilitated widespread use.

Market drivers:

  • Aging populations globally heighten constipation prevalence, expanding PEG-3350 consumption.
  • Rising awareness of minimally invasive bowel prep techniques bolsters demand.
  • Generic formulations and OTC availability reduce costs, increasing accessibility.

Challenges:

  • Competition from other laxatives and natural remedies.
  • Regulatory scrutiny over safety profiles, especially concerning long-term use.

Financial trajectory:
The global PEG laxative market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% through 2027, driven by broad consumer adoption and expanding indications [1].

Potassium Chloride

A vital electrolyte supplement for hypokalemia, potassium chloride formulations are predominantly used in hospital settings, chronic care, and emergency medicine.

Market drivers:

  • Growing prevalence of chronic kidney disease and electrolyte imbalances.
  • Increase in cardiac diseases requiring electrolyte management.
  • The surge in inpatient and outpatient electrolyte replacement therapies.

Challenges:

  • Potential for severe hyperkalemia if improperly administered.
  • Competition from alternative electrolyte products.

Financial trajectory:
The potassium chloride market anticipates a steady CAGR of roughly 3-4% over the coming years, with North America commanding a significant share due to high chronic disease prevalence and advanced healthcare infrastructure [2].

Sodium Bicarbonate

Used extensively as an antacid, alkalinizing agent, and systemic buffer, sodium bicarbonate's utilization spans emergency corrections of acidosis to chronic gastrointestinal conditions.

Market drivers:

  • Growing incidence of metabolic acidosis and renal conditions.
  • Emergency care applications, especially in trauma and cardiac events.
  • Increasing use in dialysis and intensive care units.

Challenges:

  • Competition from other antacids and bicarbonate alternatives.
  • Variability in formulations influencing efficacy and safety perceptions.

Financial trajectory:
The sodium bicarbonate market is expected to expand modestly at a CAGR of around 3% through 2027, heavily influenced by hospital demand and global health trends [3].

Sodium Chloride

As a core electrolyte and intravenous (IV) fluid component, sodium chloride is essential in hydration therapy and repletion protocols.

Market drivers:

  • Increasing hospitalization rates for dehydration, trauma, and surgical procedures.
  • Growing adoption of IV therapy worldwide.
  • Rising prevalence of infectious diseases leading to electrolyte disturbances.

Challenges:

  • Variability in global healthcare infrastructure affects access.
  • Regulatory concerns regarding contamination and purity standards.

Financial trajectory:
Projected to grow at a CAGR of 2-3%, the sodium chloride segment’s trajectory aligns with infrastructural development in emerging markets and expanding hospital networks [4].


Market Dynamics Influencing Growth

Regulatory Environment
Stringent quality standards, especially in developed markets, influence manufacturing costs and product pricing. The US FDA and EMA enforce rigorous safety and efficacy evaluations, impacting both branded and generic products. Recent focus on purity standards and labeling drives innovation and compliance costs.

Patent and Generic Competition
Many formulations, such as PEG-3350 and sodium bicarbonate, have off-patent status, fostering intense price competition. This commoditization pressure suppresses margins yet broadens supply, enhancing accessibility.

Manufacturing Innovations
Advances in formulation technology improve stability, bioavailability, and patient compliance. Continuous process improvements reduce costs and ensure consistent product quality, benefiting market growth.

Distribution Channels
Expanding OTC channels and e-commerce platforms elevate product reach, particularly for PEG-3350. Hospital procurement and partnerships with pharmacy chains sustain steady demand for electrolyte solutions and IV therapies.


Financial Outlook and Investment Considerations

The compounded growth across these drugs encapsulates a resilient yet competitive market landscape. Investment prospects lie in differentiated formulations, innovative delivery methods, and emerging markets.

Revenue Forecast Estimates:

  • PEG-3350: CAGR of ~4-5%, potentially surpassing \$1.2 billion globally by 2027.
  • Potassium Chloride: CAGR of 3-4%, with revenues exceeding \$600 million.
  • Sodium Bicarbonate: CAGR around 3%, with market size approaching \$400 million.
  • Sodium Chloride: Growth modest at 2-3%, with revenues exceeding \$2 billion driven by hospital uses.

Emerging markets in Asia-Pacific and Latin America are poised for higher double-digit growth rates due to expanding healthcare infrastructure and affordability.

Risk Factors:

  • Regulatory delays or bans stemming from safety concerns.
  • Competitive pressures from generics.
  • Fluctuating raw material prices, especially for salt-based compounds.

Key Market Drivers

  • Demographic Trends: Aging populations with chronic health conditions elevate demand.
  • Healthcare Policy Shifts: Emphasis on outpatient care and minimally invasive procedures expand OTC and home-use markets.
  • Technological Progress: Improvements in formulation stability and delivery enhance compliance and safety.
  • Global Health Initiatives: Increased focus on managing electrolyte imbalances and GI conditions worldwide.

Challenges and Market Barriers

  • Regulatory Stringency: Focus on safety and quality standards increases compliance costs.
  • Competitive Landscape: Loss of exclusivity and pricing pressures from generics constrain margins.
  • Supply Chain Constraints: Raw material variability and geopolitical issues affect manufacturing stability.
  • Public Perception and Safety: Concerns over long-term use, especially for PEG-3350, necessitate ongoing safety evaluations and consumer education.

Conclusion

The market trajectories for PEG-3350, potassium chloride, sodium bicarbonate, and sodium chloride reflect a combination of steady growth driven by demographic and clinical trends, balanced against regulatory and competitive challenges. While mature markets face margin pressures, emerging regions offer substantial upside, especially through increased healthcare infrastructure and expanding OTC channels.

Industry players must prioritize innovation, regulatory compliance, and strategic geographic expansion to capitalize on this sustained demand. Stakeholders should monitor safety data developments and technological advancements to adjust investment strategies proactively.


Key Takeaways

  • The global demand for electrolyte solutions and laxatives remains robust, driven by demographic shifts and expanding clinical applications.
  • PEG-3350 is projected to lead growth, supported by OTC availability and uses in bowel preparation.
  • Potassium chloride and sodium bicarbonate markets will benefit from rising prevalence of chronic illnesses and emergency medical needs.
  • Market consolidation via generics introduces pricing pressures but sustains widespread access.
  • Emerging markets represent significant growth opportunities, especially in Asia-Pacific and Latin America, requiring tailored regulatory and supply chain strategies.

FAQs

Q1: What factors are most likely to disrupt the market for these drugs in the next five years?
A: Major disruptions could stem from regulatory changes, safety concerns—particularly with long-term use of PEG-3350—emerging alternative therapies, or supply chain disruptions affecting raw material availability.

Q2: How does patent expiration influence the market for PEG-3350?
A: Patent expiration has facilitated generic manufacturing, increasing competition, lowering prices, and expanding accessibility, but also putting pressure on branded formulations' margins.

Q3: Are there recent technological advancements impacting the formulation or administration of these drugs?
A: Yes. Innovations include sustained-release formulations, improved flavoring and palatability, and alternative delivery mechanisms, all enhancing patient adherence and safety profiles.

Q4: Which geographic markets offer the highest growth potential for these drugs?
A: The Asia-Pacific region, driven by population growth and expanding healthcare infrastructure, offers the highest growth potential, followed by Latin America and emerging markets in Africa.

Q5: How do regulatory authorities impact the financial trajectories of these drugs?
A: Stringent safety and efficacy standards increase development costs and approval timelines but can also enhance market confidence and product value when compliance is achieved.


References
[1] Market Research Future, "Global PEG Laxative Market," 2022.
[2] Grand View Research, "Potassium Chloride Market Analysis," 2022.
[3] Fortune Business Insights, "Sodium Bicarbonate Market Size & Industry Analysis," 2022.
[4] MarketsandMarkets, "Sodium Chloride Market," 2022.

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