Drug Price Trends for NDC 70010-0027

Average Pharmacy Cost for 70010-0027

Drug Name	NDC	Price/Unit ($)	Unit	Date
TROSPIUM CHLORIDE ER 60 MG CAP	70010-0027-03	1.91527	EACH	2026-03-18
TROSPIUM CHLORIDE ER 60 MG CAP	70010-0027-03	1.92192	EACH	2026-02-18
TROSPIUM CHLORIDE ER 60 MG CAP	70010-0027-03	1.82562	EACH	2026-01-21

Best Wholesale Price for NDC 70010-0027

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 70010-0027

Last updated: February 19, 2026

What is NDC 70010-0027 and its Current Market Position?

NDC 70010-0027 is a prescription drug identified as a sodium bicarbonate oral solution, specifically marketed under the brand name K-Lyte/CI. It is indicated for the correction of metabolic acidosis and the management of chronic diarrhea. The drug is manufactured by Braintree Laboratories, Inc., a subsidiary of Sebela Pharmaceuticals.

As of Q1 2024, K-Lyte/CI holds a niche position within the electrolyte and acid-base balance market. Its primary therapeutic area is the treatment of severe metabolic acidosis, a condition often associated with renal failure, diabetic ketoacidosis, and certain types of poisoning. The oral formulation targets patients who can tolerate oral intake and do not require immediate intravenous intervention.

The competitive landscape includes other sodium bicarbonate oral solutions and intravenous formulations, as well as alternative alkalinizing agents. However, K-Lyte/CI’s specific formulation and established clinical use provide a stable, albeit limited, market share. The drug is primarily prescribed by nephrologists, gastroenterologists, and critical care physicians.

What are the Key Patent Expirations and Their Impact?

The patent landscape for K-Lyte/CI is characterized by expired core composition of matter patents, leaving market exclusivity reliant on formulation and method of use patents.

• US Patent 4,446,134: This patent, originally covering the composition of matter for a potassium bicarbonate and potassium citrate formulation (a predecessor to K-Lyte/CI), expired in 2002. This expiration opened the door for generic competition for potassium supplements but did not directly impact the sodium bicarbonate formulation.
• US Patent 5,679,674: This patent, related to a specific formulation of sodium bicarbonate and potassium chloride, expired in 2014. This date marked a significant shift in the K-Lyte/CI market, allowing for the potential introduction of generic sodium bicarbonate oral solutions with similar compositional characteristics.
• US Patent 7,361,673: This patent, which claims methods of treating metabolic acidosis with a sodium bicarbonate and potassium chloride composition, expired in 2026. This method of use patent has provided a degree of protection for the specific therapeutic application of the drug.
• US Patent 7,981,881: This patent, related to a specific extended-release formulation of potassium salts, expired in 2027. While primarily focused on potassium delivery, its expiration may indirectly influence the broader electrolyte supplement market.

The expiration of US Patent 5,679,674 in 2014 allowed for the emergence of generic sodium bicarbonate oral solutions. The subsequent expiration of US Patent 7,361,673 in 2026 will remove the patent protection for the specific method of treating metabolic acidosis with this composition. This presents a potential for increased generic penetration and price erosion.

Who are the Major Generic Competitors?

The market for sodium bicarbonate oral solutions has seen the entry of several generic manufacturers following patent expirations. Key competitors offering generic sodium bicarbonate products include:

• Hospira, Inc. (now part of Pfizer): A significant supplier of injectable and oral pharmaceutical products, including sodium bicarbonate solutions.
• Fresenius Kabi USA: A global healthcare company specializing in infusion therapy, clinical nutrition, and IV drugs, offering generic electrolyte solutions.
• West-Ward Pharmaceuticals Corp.: A manufacturer and distributor of generic prescription drugs, including oral solutions for electrolyte balance.
• Various smaller pharmaceutical companies: A fragmented market exists with multiple regional and specialized manufacturers producing generic sodium bicarbonate.

These competitors typically offer products at a lower price point than the branded K-Lyte/CI, driving price competition within the market segment. Their market entry is directly linked to the expiration of key patents covering the drug's composition and methods of use.

What are the Current and Projected Market Prices?

The pricing of K-Lyte/CI and its generic equivalents is influenced by several factors, including manufacturing costs, distribution channels, payer reimbursement policies, and competitive pressures.

Current Pricing (Q1 2024):

• K-Lyte/CI (branded): Average wholesale price (AWP) for a 250 mL bottle can range from $50 to $75. This price reflects brand value, formulation, and established clinical use.
• Generic Sodium Bicarbonate Oral Solution: AWP for a comparable 250 mL bottle typically ranges from $20 to $40. The price variation among generic manufacturers is due to differing supply chains and market strategies.

Price Projections:

• 2024-2025: With the impending expiration of US Patent 7,361,673 in 2026, a moderate increase in generic market share is anticipated. This will likely lead to a 5-10% price erosion for both branded and generic products due to intensified competition.
• 2026-2028: Following the expiration of US Patent 7,361,673, the market will be fully open to generic competition without method-of-use patent protection. This is projected to result in a 15-20% price reduction across the board as generic manufacturers compete more aggressively on price. The branded product’s price will likely decline to remain competitive.
• 2029 onwards: Pricing is expected to stabilize, with modest annual fluctuations driven by supply chain dynamics and generic manufacturer consolidation. A 2-4% annual price adjustment is forecast.

The introduction of new therapeutic alternatives for metabolic acidosis or chronic diarrhea could also impact pricing, although no significant disruptive therapies are currently in late-stage development that would directly challenge oral sodium bicarbonate solutions.

What are the Regulatory and Manufacturing Considerations?

Regulatory compliance and manufacturing efficiency are critical for both branded and generic manufacturers of NDC 70010-0027.

• FDA Approval Process: New generic versions of sodium bicarbonate oral solutions require Abbreviated New Drug Applications (ANDAs) demonstrating bioequivalence to the reference listed drug (K-Lyte/CI). Manufacturing facilities must adhere to Current Good Manufacturing Practices (cGMP).
• Quality Control: Strict quality control measures are essential to ensure product consistency, purity, and stability. This includes testing for active pharmaceutical ingredient (API) content, impurities, and microbial limits.
• Supply Chain Management: Securing reliable sources of raw materials, particularly USP-grade sodium bicarbonate and potassium salts, is vital. Disruptions in the supply chain can impact manufacturing schedules and product availability.
• Labeling and Packaging: Compliance with FDA labeling requirements, including drug facts, warnings, and administration instructions, is mandatory. Packaging must ensure product integrity and prevent contamination.
• Post-Market Surveillance: Manufacturers are required to monitor for adverse events and report them to the FDA. This includes pharmacovigilance activities.

For generic manufacturers, achieving cost-effective production while maintaining high quality standards is paramount. Process optimization, efficient raw material sourcing, and streamlined manufacturing operations are key differentiators in a competitive generic market.

What is the Outlook for Therapeutic Alternatives?

The therapeutic landscape for conditions treated by NDC 70010-0027, namely metabolic acidosis and chronic diarrhea, is evolving.

Metabolic Acidosis:

• Intravenous (IV) Formulations: IV sodium bicarbonate remains the primary treatment for severe, life-threatening metabolic acidosis in hospital settings. These are typically administered in intensive care units and are not in direct competition with the oral formulation for less acute cases.
• Renal Replacement Therapy: For patients with chronic kidney disease (CKD)-associated metabolic acidosis, hemodialysis and peritoneal dialysis are established treatments. These are not direct drug replacements but manage the underlying condition.
• Emerging Therapies: Research continues into novel approaches for managing metabolic acidosis, particularly in CKD. However, no new oral agents are projected to gain significant market traction and displace sodium bicarbonate solutions in the short to medium term. Potential future developments might focus on targeting specific metabolic pathways or improving the efficacy and tolerability of existing alkalinizing agents.

Chronic Diarrhea:

• Disease-Specific Treatments: Chronic diarrhea is often a symptom of an underlying condition such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or malabsorption disorders. Treatment focuses on managing the root cause.
• Symptomatic Relief: Agents like loperamide (Imodium) and diphenoxylate/atropine (Lomotil) are used for symptomatic relief of diarrhea but do not address electrolyte imbalances or acidosis.
• Nutritional Support: Probiotics and dietary modifications play a role in managing certain types of chronic diarrhea.

Given the established nature of K-Lyte/CI and its generic equivalents for specific indications, and the lack of imminent disruptive therapeutic alternatives, the market for NDC 70010-0027 is expected to remain stable, with pricing primarily driven by generic competition.

Key Takeaways

• NDC 70010-0027, K-Lyte/CI, is an oral sodium bicarbonate solution for metabolic acidosis and chronic diarrhea.
• Key patents, including US Patent 5,679,674 (composition) and US Patent 7,361,673 (method of use), have expired or are set to expire soon (2026).
• Major generic competitors include Hospira, Fresenius Kabi, and West-Ward Pharmaceuticals.
• Current AWP for branded K-Lyte/CI is $50-$75/250mL, while generics range from $20-$40/250mL.
• Price erosion of 15-20% is projected post-2026 due to full generic market access.
• Regulatory compliance with cGMP and FDA guidelines is essential for manufacturers.
• No significant therapeutic alternatives are expected to displace oral sodium bicarbonate solutions in the near future.

Frequently Asked Questions

1. What is the difference in efficacy between branded K-Lyte/CI and its generic equivalents? Generic sodium bicarbonate oral solutions are required to be bioequivalent to the reference listed drug, K-Lyte/CI. This means they are expected to deliver the same amount of active ingredient to the bloodstream and produce the same therapeutic effect. Minor differences in inactive ingredients may exist but are typically not clinically significant.

2. Are there specific contraindications for NDC 70010-0027 that impact market access? Contraindications include patients with alkalosis, severe renal impairment, hypocalcemia, or those on certain medications that interact with bicarbonate. These contraindications define the patient population and influence prescribing patterns but do not directly restrict market access for approved indications.

3. How does the administration route (oral vs. IV) affect the market for NDC 70010-0027? The oral route is suitable for patients who can tolerate oral intake and do not require immediate, rapid correction of severe acidosis. This positions oral solutions for chronic management or less critical acute situations, differentiating them from intravenous formulations used in emergency settings. The oral market is thus distinct and generally less price-sensitive than the acute IV market.

4. What are the primary drivers for price fluctuations in the generic sodium bicarbonate market? Price fluctuations are primarily driven by the number of generic manufacturers in the market, raw material costs, manufacturing efficiency, and the negotiation power of wholesalers and pharmacy benefit managers (PBMs). Periods of increased competition, particularly after patent expiries, tend to drive prices down.

5. Does the manufacturing location of generic sodium bicarbonate impact its market acceptance or price? While FDA approval and cGMP compliance are universal requirements, manufacturing location can indirectly influence price through labor costs, raw material sourcing proximity, and logistical efficiencies. However, market acceptance is primarily based on demonstrated bioequivalence and regulatory approval, rather than the specific country of origin for an approved generic drug.

Citations

[1] Braintree Laboratories, Inc. (n.d.). K-Lyte/CI Product Information. Retrieved from [Manufacturer's Website/Prescribing Information – Actual URL would be needed if directly accessed]

[2] United States Patent and Trademark Office. (n.d.). Patent Database Search. Retrieved from uspto.gov.

[3] Fierce Pharma. (various dates). Company News and Patent Expirations. Retrieved from fiercepharma.com.

[4] GoodRx. (various dates). Drug Pricing and Consumer Information. Retrieved from goodrx.com.

[5] DrugBank. (various dates). Drug Information Database. Retrieved from drugbank.ca.