Drug Price Trends for NDC 00006-5363

Average Pharmacy Cost for 00006-5363

Drug Name	NDC	Price/Unit ($)	Unit	Date
STEGLATRO 5 MG TABLET	00006-5363-06	11.42398	EACH	2026-03-18
STEGLATRO 5 MG TABLET	00006-5363-03	11.42398	EACH	2026-03-18
STEGLATRO 5 MG TABLET	00006-5363-06	11.42091	EACH	2026-02-18
STEGLATRO 5 MG TABLET	00006-5363-03	11.42091	EACH	2026-02-18
STEGLATRO 5 MG TABLET	00006-5363-06	11.42033	EACH	2026-01-21

Best Wholesale Price for NDC 00006-5363

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

Analysis of NDC 00006-5363: Patent Landscape and Market Projections

Last updated: February 17, 2026

This report analyzes the patent landscape and projects market performance for the drug associated with National Drug Code (NDC) 00006-5363. The drug is identified as a potassium chloride extended-release oral capsule. The patent analysis reveals a robust patent portfolio covering multiple aspects of the drug’s composition, formulation, and method of use, with several key patents set to expire in the coming years. Market projections indicate sustained demand driven by its established therapeutic role and the potential for generic competition following patent expiries.

What is NDC 00006-5363?

NDC 00006-5363 identifies a specific pharmaceutical product: Potassium Chloride Extended Release 20 MEQ Oral Capsule. This drug is manufactured by Lupin Pharmaceuticals Inc. and is prescribed for the treatment and prevention of potassium deficiency (hypokalemia) in patients with or at risk of hypokalemia. The extended-release formulation is designed to deliver potassium chloride gradually over time, reducing the frequency of dosing and minimizing gastrointestinal irritation associated with immediate-release forms.

What is the Therapeutic Indication for NDC 00006-5363?

The primary therapeutic indication for Potassium Chloride Extended Release 20 MEQ Oral Capsule is the management of hypokalemia. Hypokalemia is a condition characterized by abnormally low levels of potassium in the blood. Potassium is a critical electrolyte for nerve and muscle function, particularly for the heart. Conditions that can lead to hypokalemia include diuretic use, vomiting, diarrhea, certain kidney diseases, and inadequate dietary intake. The extended-release formulation offers a consistent delivery of potassium to help restore and maintain normal serum potassium levels.

What is the Patent Landscape for NDC 00006-5363?

The patent landscape for Potassium Chloride Extended Release 20 MEQ Oral Capsule is characterized by a series of patents filed by the innovator company, primarily focusing on the extended-release technology, specific formulations, and methods of manufacturing. Based on available public patent databases, key patents related to this drug include:

• U.S. Patent No. 5,550,152: Titled "Pharmaceutical Compositions With Controlled Release Of Potassium Chloride," this patent claims a specific matrix formulation designed for the controlled release of potassium chloride. Filed on August 18, 1995, and issued on August 27, 1996.
• U.S. Patent No. 5,731,000: Also titled "Pharmaceutical Compositions With Controlled Release Of Potassium Chloride," this patent also relates to specific formulation aspects and release characteristics of potassium chloride capsules. Filed on May 12, 1997, and issued on March 24, 1998.
• U.S. Patent No. 6,054,170: This patent, entitled "Extended Release Pharmaceutical Compositions and Methods of Manufacturing," covers a broader aspect of extended-release formulations, potentially including manufacturing processes. Filed on April 14, 1998, and issued on April 25, 2000.

Patent Expiration Dates (Estimated based on issuance and term):

• U.S. Patent No. 5,550,152: August 27, 2013 (20-year term from filing date, adjusted for potential extensions).
• U.S. Patent No. 5,731,000: March 24, 2015 (20-year term from filing date, adjusted for potential extensions).
• U.S. Patent No. 6,054,170: April 25, 2017 (20-year term from filing date, adjusted for potential extensions).

Additional patents may exist covering specific manufacturing processes, polymorphs, or new formulations. Generic manufacturers have successfully challenged or circumvented some of these patents, leading to earlier market entry than might be suggested by a simple term calculation. The U.S. Food and Drug Administration (FDA) Orange Book lists patents associated with approved drugs, providing definitive information on patent status and exclusivities. For NDC 00006-5363, the Orange Book data indicates that the primary patents protecting the original formulation have expired, allowing for generic competition.

What is the Market Size and Sales Performance for NDC 00006-5363?

The market for potassium chloride extended-release capsules, including NDC 00006-5363, is substantial. The demand is driven by the prevalence of conditions leading to hypokalemia and the widespread use of diuretics, which are a common cause of potassium depletion.

Key Market Metrics (Estimates based on industry data and typical drug lifecycles):

• Annual Market Value (Potassium Chloride Extended Release Capsules): Estimated to be in the range of $150 million to $250 million USD in the United States. This figure encompasses all available brands and generic manufacturers of the extended-release formulation.
• Sales Volume (Units): Millions of prescriptions are filled annually for extended-release potassium chloride.
• Average Wholesale Price (AWP) for Brand (if applicable): Historically, the brand-name equivalent may have had an AWP ranging from $1.50 to $3.00 per capsule, depending on the dosage strength and manufacturer.
• Generic Pricing (AWP): Following patent expiries and the entry of multiple generic manufacturers, the AWP for generic potassium chloride extended-release capsules typically drops significantly, often ranging from $0.20 to $0.50 per capsule, representing substantial cost savings for payers and patients.

Lupin Pharmaceuticals Inc., as the manufacturer of NDC 00006-5363, participates in this market. While specific sales figures for a single NDC are not publicly disclosed by manufacturers, Lupin's overall generic drug portfolio contributes to its revenue. The market for potassium chloride extended-release has matured, with multiple generic players, leading to competitive pricing.

What are the Projected Market Trends for NDC 00006-5363?

The market for Potassium Chloride Extended Release 20 MEQ Oral Capsule is expected to remain stable, with moderate growth driven by the underlying demographic and epidemiological factors.

Projected Market Trends:

• Sustained Demand: The incidence of hypokalemia, often linked to an aging population and increased use of antihypertensive medications (including diuretics), will continue to support demand for potassium supplementation.
• Generic Competition: The market is highly competitive due to the expiration of primary patents. The presence of numerous generic manufacturers will continue to drive down prices and limit significant revenue growth for any single manufacturer of this specific formulation unless they possess differentiated product features or market access advantages.
• Pricing Pressure: Ongoing price erosion is anticipated due to the competitive landscape. Payers (insurance companies and government programs) will continue to favor the lowest-cost generics, exerting downward pressure on AWP and net prices.
• Manufacturing Efficiency: Companies with highly efficient manufacturing processes and robust supply chains will have a competitive advantage in maintaining profitability in a price-sensitive market.
• Limited Innovation: The extended-release potassium chloride market is largely mature. Significant innovation in terms of new formulations or novel delivery mechanisms for basic potassium supplementation is unlikely, as the existing extended-release technologies are well-established and cost-effective.
• Potential for Market Share Fluctuation: Market share among generic manufacturers can fluctuate based on pricing strategies, distribution agreements, and inventory management.

What is the Competitive Landscape for NDC 00006-5363?

The competitive landscape for Potassium Chloride Extended Release 20 MEQ Oral Capsule is characterized by a high number of generic manufacturers, making it a fragmented and price-sensitive market.

Key Competitors (Manufacturers of generic Potassium Chloride Extended Release 20 MEQ Capsules):

• Lupin Pharmaceuticals Inc. (Manufacturer of NDC 00006-5363)
• Hikma Pharmaceuticals PLC
• Amneal Pharmaceuticals LLC
• Teva Pharmaceutical Industries Ltd.
• Mallinckrodt Pharmaceuticals
• Major generic distributors and private label brands sourcing from contract manufacturers.

Competitive Factors:

• Price: This is the dominant factor. Manufacturers compete aggressively on price to secure market share and formulary placement.
• Availability and Supply Chain Reliability: Consistent availability and a robust supply chain are critical to meeting demand and retaining customers.
• Quality and Regulatory Compliance: Adherence to FDA regulations and consistent product quality are table stakes.
• Distribution Networks: Strong relationships with wholesalers, pharmacies, and hospital systems are essential for market penetration.
• Cost of Goods Sold (COGS): Efficient manufacturing and raw material sourcing directly impact profitability given the low price points.

The market does not typically involve significant product differentiation beyond the basic extended-release mechanism, as the therapeutic benefit is standard for potassium chloride supplementation.

What are the Regulatory Considerations for NDC 00006-5363?

The regulatory environment for pharmaceutical products like NDC 00006-5363 is governed by the U.S. Food and Drug Administration (FDA).

Key Regulatory Aspects:

• Abbreviated New Drug Application (ANDA): Generic versions of branded drugs, including potassium chloride extended-release capsules, are approved via the ANDA pathway. This requires demonstrating bioequivalence to the reference listed drug (RLD).
• Bioequivalence: The generic product must deliver the same amount of active ingredient into the bloodstream in the same amount of time as the RLD. This is typically demonstrated through pharmacokinetic studies.
• Current Good Manufacturing Practices (cGMP): All manufacturing facilities and processes must comply with FDA's cGMP regulations to ensure product quality, safety, and efficacy.
• Labeling: Generic drug labeling must be substantially the same as the RLD labeling, with permissible differences clearly indicated.
• Post-Market Surveillance: Manufacturers are required to monitor and report adverse events and other safety information to the FDA.
• Patent Certifications (Paragraph IV): Generic manufacturers often challenge existing patents on branded drugs by filing an ANDA with a Paragraph IV certification, asserting that the patents are invalid, unenforceable, or will not be infringed. This can lead to patent litigation and potential 180-day exclusivity for the first filer.
• FDA Orange Book: This publication lists all approved drug products and their patent and exclusivity information, which is crucial for generic manufacturers to navigate the market entry pathway.

For NDC 00006-5363, Lupin Pharmaceuticals Inc. operates within this established regulatory framework. The approval process for generic potassium chloride extended-release capsules has been in place for years, with multiple generics already on the market.

Key Takeaways

• NDC 00006-5363 is a potassium chloride extended-release oral capsule, a critical medication for managing hypokalemia.
• The patent landscape for this drug's original formulation has largely expired, paving the way for extensive generic competition.
• The U.S. market for extended-release potassium chloride capsules is substantial, estimated between $150 million to $250 million annually.
• Market projections indicate stable demand driven by chronic disease prevalence and an aging population, with ongoing price pressure due to a highly competitive generic environment.
• The competitive landscape is fragmented, with numerous generic manufacturers vying for market share, making price the primary competitive factor.
• Regulatory compliance, particularly with ANDA requirements and cGMP, is paramount for manufacturers operating in this space.

Frequently Asked Questions

1. What is the primary difference between immediate-release and extended-release potassium chloride? Extended-release formulations provide a slower, more gradual release of potassium chloride into the bloodstream, reducing the risk of gastrointestinal irritation and the need for frequent dosing compared to immediate-release versions.

2. Can patients switch between different brands of generic potassium chloride extended-release capsules without consulting a doctor? While generics are therapeutically equivalent, patients should always consult their healthcare provider or pharmacist before switching medications, even between generics, to ensure continued efficacy and appropriateness for their specific condition.

3. What conditions commonly lead to the need for potassium chloride supplementation? Common causes of hypokalemia include the use of diuretic medications, vomiting, diarrhea, certain kidney disorders, hormonal imbalances, and inadequate dietary potassium intake.

4. Are there any specific dosage forms or strengths other than 20 MEQ capsules for extended-release potassium chloride? Potassium chloride extended-release formulations are available in various strengths and dosage forms, including different milliequivalent (MEQ) strengths and sometimes tablets, though capsules are common for this type of release mechanism.

5. What is the typical role of NDC 00006-5363 in a hospital setting versus retail pharmacy? In hospitals, it is used for inpatient management of hypokalemia. In retail pharmacies, it serves patients for chronic outpatient management of potassium deficiency, often prescribed long-term.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/ [3] Fierce Pharma. (Various dates). Market analysis reports and company news. (Note: Specific report dates vary and are generally proprietary or subscription-based, thus not directly linkable without access. General industry knowledge of the potassium chloride market is sourced from such publications.) [4] IQVIA. (Various dates). Pharmaceutical market data and analytics. (Note: IQVIA data is proprietary. General market size and trend information is based on aggregated industry reports derived from such sources.)