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Last Updated: March 26, 2026

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - Generic Drug Details


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What are the generic drug sources for bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride and what is the scope of patent protection?

Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride is the generic ingredient in two branded drugs marketed by Braintree and Novel Labs Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

US Patents and Regulatory Information for BISACODYL; POLYETHYLENE GLYCOL 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
Braintree HALFLYTELY bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551-003 Jul 16, 2010 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novel Labs Inc PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 202217-001 Aug 20, 2014 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Braintree HALFLYTELY bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551-003 Jul 16, 2010 7,291,324 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Key Laxative and Electrolyte Drugs

Last updated: February 20, 2026


How does the bisacodyl market develop?

Bisacodyl, a stimulant laxative, primarily addresses constipation. It is available OTC and through prescription. The global market is growing steadily, driven by aging populations and increased gastrointestinal disorder awareness. In 2022, the market size was approximately USD 600 million; projections estimate a compound annual growth rate (CAGR) of 4% through 2028. Key regions include North America, Europe, and parts of Asia-Pacific, with OTC sales accounting for nearly 75%. Major manufacturers such as Sanofi and Boehringer Ingelheim dominate the supply chain.

Market Drivers

  • Increasing prevalence of constipation globally.
  • Growing acceptance of OTC medications.
  • Expanding elderly demographic.

Market Challenges

  • Patent expiries for certain formulations.
  • Competition from newer laxatives and formulations.

What is the financial outlook for polyethylene glycol 3350 (PEG 3350)?

PEG 3350 is a saline osmotic laxative used primarily for chronic constipation and bowel cleansing. The global market was valued around USD 350 million in 2022, with an expected CAGR of 5% until 2028. The product benefits from high safety profiles and widespread prescription use, especially in North America and Europe. Generic versions have increased market competition, reducing pricing power for original formulations.

Regulatory and Commercial Factors

  • Approved for OTC and prescription use in multiple regions.
  • Price sensitivity influences margins.
  • Patent protection expires in most markets, amplifying generic penetration.

How does potassium chloride (KCl) influence market trends?

Potassium chloride supplements are used to prevent or treat hypokalemia, especially among patients on diuretics or with certain health conditions. The global market was valued at USD 2.2 billion in 2022 with a CAGR of 3%. It features multiple forms: tablets, powders, and IV solutions. The market is driven by rising cardiovascular disease prevalence and hospital-based therapies. Monitored use in clinical settings limits OTC sales.

Regulatory landscape

  • Stringent regulation governs IV and oral formulations.
  • Growing demand in emerging markets boosts volume.

What is the forecast for sodium bicarbonate?

Sodium bicarbonate, used as an antacid, systemic alkalizer, and in dialysis, had an estimated market size of USD 1.2 billion in 2022. The market is projected to grow at a CAGR of 3.5% through 2028. It benefits from diverse applications ranging from gastrointestinal relief to emergency medicine and baking industries. It is widely available OTC, with hospital demand for IV formulations increasing due to chronic kidney disease.

Growth factors and challenges

  • Increasing gastrointestinal disorder treatments.
  • Supply chain issues affecting raw material costs.
  • Market saturation in developed economies limits rapid expansion.

How does sodium chloride (NaCl) fare in market dynamics?

Sodium chloride, especially in intravenous forms, is critical in fluid and electrolyte therapy. The global market was valued at USD 4.5 billion in 2022, with an expected CAGR of 2.8%. Hospitals and clinics heavily influence sales. Growing chronic illnesses and dehydration cases sustain steady demand. Competition from alternative electrolytes and salt replacement solutions exists but has limited impact on core demand.

Market overview

  • Dominated by large pharmaceutical and electrolyte solution manufacturers.
  • Price fluctuations relate to raw material costs, especially salt and packaging materials.

Comparative Market Analysis

Drug 2022 Market Size CAGR (2023–2028) Key Regional Markets Major Players
Bisacodyl USD 600M 4% North America, Europe Sanofi, Boehringer Ingelheim
PEG 3350 USD 350M 5% North America, Europe Nupo, Roche
Potassium chloride USD 2.2B 3% Global, especially North America Hospira, Pfizer
Sodium bicarbonate USD 1.2B 3.5% North America, Europe Pfizer, Novartis
Sodium chloride USD 4.5B 2.8% Global Baxter, Fresenius

Key Takeaways

  • Market growth is driven by aging populations, increasing gastrointestinal disorders, and hospital demand.
  • OTC availability influences sales for bisacodyl, sodium bicarbonate, and certain PEG formulations.
  • Patent expiries and generic competition moderately suppress margins across products.
  • Increasing regulation, especially for electrolytes like KCl and IV sodium chloride, influences supply chain and pricing.
  • Emerging markets offer new growth avenues due to rising healthcare infrastructure investment.

FAQs

1. What are the main drivers for growth in the bisacodyl market?
Aging populations and rising awareness of gastrointestinal health increase demand. OTC availability further facilitates sales.

2. How does generic competition impact PEG 3350 pricing?
The expiration of patents results in multiple generic options, reducing prices and margins for original branded formulations.

3. Are there supply chain risks affecting sodium bicarbonate?
Yes. Raw material costs and manufacturing disruptions influence availability and pricing.

4. What regional differences exist in the potassium chloride market?
North America dominates due to high cardiovascular disease prevalence, while emerging markets are expanding usage due to increased healthcare access.

5. How is regulatory oversight affecting sodium chloride IV solutions?
Stringent regulations on manufacturing and administration impact supply, but demand remains stable due to essential medical use.


References

[1] MarketsandMarkets. (2023). Laxatives Market by Type, Application, and Region. Retrieved from https://www.marketsandmarkets.com

[2] Grand View Research. (2022). Electrolyte Solutions Market Insights. Retrieved from https://www.grandviewresearch.com

[3] IQVIA. (2022). Pharmaceutical Market Reports. Retrieved from https://www.iqvia.com

[4] GlobalData. (2023). Gastrointestinal Therapeutics Market Assessment. Retrieved from https://www.globaldata.com

[5] Statista. (2023). Global Pharmaceuticals Market Revenue. Retrieved from https://www.statista.com

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