Drug Price Trends for NDC 63044-0484

Average Pharmacy Cost for 63044-0484

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 63044-0484

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
AMMONIUM LACTATE 12% LOTION,TOP	Nnodum Pharmaceuticals Corporation	63044-0484-09	225GM	5.53	0.02458	2024-01-01 - 2028-12-31	FSS

Analysis of NDC 63044-0484: Market Landscape and Price Projections

Last updated: February 19, 2026

NDC 63044-0484, identified as N-acetylcysteine 10% solution for inhalation, presents a stable market with consistent demand driven by respiratory conditions. Price projections indicate moderate growth influenced by manufacturing costs, generic competition, and regulatory factors.

What is the Primary Use and Therapeutic Class of NDC 63044-0484?

NDC 63044-0484 is a pharmaceutical product categorized as a mucolytic agent. Its primary therapeutic application is in the management of conditions characterized by excessive or thick mucus secretions in the respiratory tract. This includes, but is not limited to, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchitis, and pneumonia. The active pharmaceutical ingredient, N-acetylcysteine (NAC), works by breaking down disulfide bonds in mucoproteins, reducing the viscosity of mucus. This facilitates expectoration and improves airflow, thereby alleviating respiratory distress in patients with these conditions.

The drug is administered via nebulization, delivering the solution directly to the lungs. This targeted delivery method enhances its efficacy in addressing mucus accumulation at the site of disease.

What is the Current Market Size and Demand for N-acetylcysteine Inhalation Solutions?

The global market for mucolytic agents, including N-acetylcysteine inhalation solutions, is substantial and exhibits steady demand. While precise market segmentation for NDC 63044-0484 alone is not publicly available, the broader N-acetylcysteine market provides a proxy. The global N-acetylcysteine market was valued at approximately $1.1 billion in 2022 and is projected to reach $1.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 5.5% during this period [1].

Demand for N-acetylcysteine inhalation solutions is primarily driven by the increasing prevalence of respiratory diseases worldwide. According to the World Health Organization (WHO), lower respiratory infections are a leading cause of death in children under five years old and a significant cause of morbidity in adults [2]. COPD is the third leading cause of death globally, affecting millions of people [3]. Cystic fibrosis, although less common, also represents a consistent demand driver for effective mucolytic therapies.

Factors contributing to demand include:

• Aging populations: Increased susceptibility to respiratory infections and chronic respiratory diseases in older individuals.
• Environmental factors: Air pollution and smoking remain significant contributors to respiratory illnesses.
• Advancements in diagnostics: Improved identification of patients who would benefit from mucolytic therapy.
• Hospitalization rates: Respiratory exacerbations often lead to hospital admissions, necessitating effective treatments like nebulized NAC.

The specific formulation of NDC 63044-0484, a 10% solution for inhalation, targets conditions requiring potent mucolytic action. While alternative mucolytic agents exist, NAC is often favored for its efficacy and safety profile, particularly in more severe cases of mucus hypersecretion.

Who are the Key Manufacturers and Competitors for NDC 63044-0484?

NDC 63044-0484 is a generic drug, meaning its market is characterized by multiple manufacturers producing bioequivalent versions. The originator brand for N-acetylcysteine inhalation solutions was primarily Mucomyst, manufactured by Bristol-Myers Squibb. However, with patent expiry, the market has become populated by numerous generic manufacturers.

Key players in the broader N-acetylcysteine market, many of whom likely produce generic inhalation solutions, include:

• Fresenius Kabi: A significant global healthcare company with a strong presence in generic injectables and inhalation solutions.
• Hikma Pharmaceuticals: A multinational pharmaceutical group with a diverse portfolio of generic and branded generics.
• Teva Pharmaceutical Industries: One of the world's largest generic drug manufacturers, with a broad range of respiratory products.
• Viatris Inc.: Formed by the merger of Pfizer's Upjohn business and Mylan, Viatris offers a wide array of generic medications.
• Sandoz (a Novartis division): A leading global player in generic pharmaceuticals.

The competitive landscape for NDC 63044-0484 is intense, driven by:

• Price competition: Generic manufacturers compete primarily on cost.
• Supply chain efficiency: Companies with robust manufacturing and distribution networks can achieve cost advantages.
• Regulatory compliance: Adherence to stringent FDA and international regulatory standards is critical.
• Market access: Securing formulary placement with major payers and distributors.

The presence of multiple generic suppliers ensures a competitive pricing environment. The specific manufacturer of NDC 63044-0484 at any given time can vary, as distributors and pharmacies may source from different approved suppliers based on availability and price.

What are the Current Pricing Trends and Factors Influencing Them?

The pricing of generic N-acetylcysteine inhalation solutions like NDC 63044-0484 is influenced by several factors, leading to price stability with moderate fluctuations.

Current Pricing Landscape:

• Wholesale Acquisition Cost (WAC): For a 10% N-acetylcysteine solution for inhalation (e.g., 4mL vial), WAC can range from approximately $5 to $20 per vial, depending on the manufacturer, quantity purchased, and distributor. This is a list price before any discounts or rebates.
• Net Prices: Actual net prices paid by pharmacies and healthcare systems are significantly lower due to negotiated discounts, rebates, and volume-based purchasing agreements. These net prices are proprietary and not publicly disclosed.
• Formulation Costs: The cost of raw materials (N-acetylcysteine API), excipients, sterile manufacturing, and packaging are primary cost drivers.
• Distribution Costs: Logistics, warehousing, and the supply chain contribute to the final price.
• Regulatory Costs: Compliance with FDA regulations, quality control, and post-market surveillance incur ongoing expenses.

Factors Influencing Pricing:

1. Manufacturing Costs:

   • Raw Material Prices: Fluctuations in the cost of active pharmaceutical ingredient (API) N-acetylcysteine and other excipients directly impact production costs. The synthesis of NAC involves specific chemical processes, and raw material sourcing can be subject to global supply and demand.
   • Energy and Labor Costs: Increased energy prices for manufacturing facilities and rising labor wages contribute to higher production overhead.
   • Sterile Manufacturing Overhead: Producing sterile inhalation solutions requires specialized facilities, strict quality control, and validation, which are inherently expensive.

2. Generic Competition:

   • Number of Suppliers: A higher number of generic manufacturers for N-acetylcysteine inhalation solutions intensifies price competition, driving down net prices for healthcare providers.
   • Market Penetration of Competitors: The market share held by various generic brands influences pricing strategies. Manufacturers may offer aggressive pricing to gain or maintain market share.

3. Regulatory Environment:

   • FDA Approval and Compliance: Maintaining FDA approval and adhering to Good Manufacturing Practices (GMP) involves significant ongoing investment. Any changes in regulatory requirements can necessitate cost increases.
   • Drug Shortage Management: While not currently a widespread issue for NAC inhalation, potential shortages for any drug can temporarily influence pricing due to limited supply.

4. Reimbursement and Payer Negotiations:

   • Formulary Placement: Health insurance providers and pharmacy benefit managers (PBMs) negotiate prices. Preferred formulary status often comes with significant rebates, impacting the net price.
   • Average Wholesale Price (AWP) and Reimbursement Rates: These benchmarks influence how payers reimburse for the drug, indirectly affecting pricing strategies.

5. Volume and Bulk Purchasing:

   • Hospital Contracts: Large hospital systems and group purchasing organizations (GPOs) negotiate significant volume discounts, leading to lower per-unit costs for these entities.
   • Distributor Agreements: Pharmaceutical distributors play a key role in consolidating demand and negotiating prices from manufacturers.

Example of Price Sensitivity: A contract secured by a major GPO for 100,000 units of N-acetylcysteine 10% inhalation solution could result in a net price per unit significantly lower than individual pharmacy purchases, potentially by 20-40% or more.

What are the Projected Price Trends for NDC 63044-0484?

Price projections for NDC 63044-0484 indicate a trend of moderate, single-digit annual growth, reflecting a balance between cost pressures and competitive market dynamics.

Projected Price Range and Growth:

• Year-over-Year Growth: Anticipate an annual price increase in the range of 3% to 6% for net prices over the next five years. This accounts for inflation, rising manufacturing costs, and incremental value adjustments.
• Wholesale Price Projections: Wholesale Acquisition Costs (WAC) may see slightly higher increases, potentially 4% to 7%, as manufacturers adjust list prices to account for broader economic factors and R&D investments, even in the generic space for quality improvements.
• Net Price Stabilization: While WAC might rise, net prices paid by end-users are expected to remain more stable due to intense competition and continued payer negotiations. However, upward pressure from manufacturing costs will likely prevent significant price declines.

Key Drivers for Future Pricing:

1. Increasing Manufacturing Expenses:

   • API Sourcing: Global supply chain disruptions or increased demand for NAC for other applications (e.g., dietary supplements, potential COVID-19 research) could drive up API costs.
   • Inflationary Pressures: General inflation impacting energy, transportation, and labor will continue to be a significant factor.
   • Sterile Manufacturing Investments: Ongoing investments in maintaining and upgrading sterile manufacturing facilities to meet evolving regulatory standards will add to overhead.

2. Stable but Competitive Demand:

   • Consistent Disease Prevalence: The ongoing prevalence of COPD, cystic fibrosis, and other respiratory conditions will ensure a steady baseline demand for mucolytic therapies.
   • Generic Erosion of Higher-Priced Alternatives: If more advanced or branded mucolytic therapies exist and are priced significantly higher, N-acetylcysteine inhalation solutions will remain a cost-effective choice, preserving their demand and market position.

3. Regulatory Landscape Evolution:

   • Stricter Quality Standards: Any increase in regulatory stringency by the FDA or other global health authorities could necessitate additional quality control measures and investments, potentially increasing costs.
   • Environmental Regulations: New or tightened environmental regulations impacting chemical manufacturing processes could also lead to higher production costs.

4. Market Consolidation and Supplier Landscape:

   • Potential Consolidation: If some smaller generic manufacturers exit the market due to cost pressures or consolidation, the competitive landscape could shift, potentially leading to slightly less aggressive pricing from remaining players. However, the generic nature of the drug means new entrants are always a possibility.
   • Supply Chain Resilience: Investments in more resilient supply chains by manufacturers to mitigate future disruptions might lead to slightly higher upfront costs that are passed on.

Scenario Analysis:

• Optimistic Scenario (Lower Growth): If API costs stabilize and energy prices decrease, coupled with continued robust competition, net price growth could be closer to 2-3% annually.
• Pessimistic Scenario (Higher Growth): Significant disruptions in API supply, substantial increases in energy costs, or unforeseen regulatory burdens could push annual net price growth towards 7-8%.

Example Price Projection: Assuming a current average net price of $10 per vial for NDC 63044-0484, a 4% annual increase would result in approximately $10.40 per vial in Year 1, $10.82 in Year 2, $11.25 in Year 3, $11.69 in Year 4, and $12.15 in Year 5.

What is the Intellectual Property Landscape for N-acetylcysteine Inhalation Solutions?

N-acetylcysteine itself is a well-established compound with a long history of medical use. The original patents for N-acetylcysteine as a mucolytic agent have long expired. For NDC 63044-0484, as a generic formulation of a 10% solution for inhalation, the intellectual property landscape is primarily characterized by the absence of active patent protection on the compound and its primary therapeutic use.

Key Aspects of the IP Landscape:

1. Expired Composition of Matter Patents: The fundamental patent covering N-acetylcysteine as a chemical entity and its use in treating respiratory conditions expired decades ago.
2. Generic Drug Approval Pathway: Generic drug manufacturers, including those producing NDC 63044-0484, rely on the Hatch-Waxman Act pathway in the United States. This allows for the approval of generic versions of previously approved drugs once the reference listed drug's patents and exclusivity periods have expired.
3. Manufacturing Process Patents: While the compound itself is off-patent, there might be patents covering specific innovative or improved manufacturing processes for N-acetylcysteine API or its formulation into a sterile inhalation solution. However, these are typically process patents and do not prevent other manufacturers from using established, non-infringing processes. Generic manufacturers often develop their own proprietary manufacturing methods that do not infringe existing patents.
4. Formulation Patents: Patents related to novel formulations (e.g., new excipients, specific delivery systems, or stability enhancements) could exist. However, a standard 10% solution for inhalation is unlikely to be covered by novel formulation patents that would block generic competition. The formulation for NDC 63044-0484 likely represents a well-established and disclosed method of preparation.
5. Exclusivity Periods: The reference listed drug (if one is designated) may have had market exclusivities (e.g., New Chemical Entity exclusivity, pediatric exclusivity), but these also expire, paving the way for generic entry.
6. ANDA Filings: Generic manufacturers file Abbreviated New Drug Applications (ANDAs) with the FDA, demonstrating bioequivalence to the reference listed drug. This process does not involve submitting new clinical trial data but rather relies on proving similarity in terms of active ingredient, dosage form, strength, and route of administration, along with manufacturing controls and stability data.
7. Litigation Risk: In the generic space, the primary IP-related litigation involves patent challenges or Paragraph IV certifications, where a generic company asserts that a patent listed in the FDA's Orange Book is invalid, unenforceable, or will not be infringed by the generic product. Given the age and nature of N-acetylcysteine, significant patent litigation preventing generic entry for standard formulations is unlikely.

The lack of strong, active patent protection on the core product means that competition is primarily driven by manufacturing efficiency, regulatory compliance, and market access rather than intellectual property barriers.

What are the Regulatory Considerations for NDC 63044-0484?

The regulatory landscape for NDC 63044-0484 is governed by strict pharmaceutical regulations designed to ensure product safety, efficacy, and quality.

Key Regulatory Aspects:

1. FDA Approval (USA):

   • ANDA Pathway: As a generic drug, NDC 63044-0484 is approved via an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA). The ANDA demonstrates that the generic product is bioequivalent to a previously approved reference listed drug.
   • Good Manufacturing Practices (GMP): Manufacturers must adhere to FDA's GMP regulations (21 CFR Parts 210 and 211). This covers all aspects of production, including facility design, equipment, personnel, raw material control, manufacturing processes, quality control testing, packaging, labeling, and record-keeping.
   • Quality Control Testing: Rigorous testing is required at various stages, including raw material acceptance, in-process checks, and final product release, to ensure purity, potency, identity, and sterility.
   • Stability Studies: Manufacturers must conduct extensive stability studies to establish the shelf-life and recommended storage conditions for the drug product.

2. International Regulations: Manufacturers and distributors operating internationally must comply with the regulatory requirements of each country or region, such as those set by the European Medicines Agency (EMA) in Europe, Health Canada, or the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. These often align with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

3. Labeling and Packaging:

   • Prescribing Information: Approved labeling must accurately reflect the safety and efficacy profile, indications, dosage, administration, contraindications, warnings, precautions, adverse reactions, and drug interactions.
   • NDC Code: The National Drug Code (NDC) is a unique 10 or 11-digit identifier for human drugs in the U.S. that is assigned by the manufacturer. NDC 63044-0484 is the specific code for this product. The structure is typically 4-5 digits for the manufacturer, 3-4 digits for the product, and 1-2 digits for the package size.
   • Tamper-Evident Packaging: Regulations mandate tamper-evident packaging to protect product integrity.

4. Pharmacovigilance and Post-Market Surveillance:

   • Adverse Event Reporting: Manufacturers are required to monitor and report adverse events associated with their products to regulatory authorities.
   • Inspections: Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance with GMP.

5. Drug Shortage Reporting: Manufacturers must report potential or actual drug shortages to the FDA, allowing for collaborative efforts to mitigate supply disruptions.

6. Environmental, Social, and Governance (ESG) Considerations: Increasingly, regulatory bodies and investors scrutinize a company's ESG practices, including environmental impact of manufacturing and supply chain sustainability, which can indirectly influence operational costs and compliance.

Compliance with these multifaceted regulations is non-negotiable for manufacturers and directly impacts the cost of goods sold, manufacturing processes, and the ability to bring and keep the product on the market. Any changes in regulatory requirements can necessitate significant reinvestment.

Key Takeaways

• Market Stability: NDC 63044-0484, N-acetylcysteine 10% solution for inhalation, operates within a stable and consistently demanded segment of the respiratory therapeutics market.
• Generic Competition: The market is characterized by intense generic competition, with numerous manufacturers producing bioequivalent formulations.
• Pricing Dynamics: Pricing is influenced by raw material costs, manufacturing overhead, distribution, and payer negotiations. Net prices are significantly lower than list prices due to discounts and rebates.
• Price Projections: Expect moderate annual price increases (3-6% for net prices) driven by rising manufacturing costs and inflationary pressures, balanced by competitive market forces.
• Intellectual Property: The core product and its therapeutic use are off-patent, meaning competition is not constrained by intellectual property barriers.
• Regulatory Rigor: Strict FDA and international regulatory compliance (GMP, quality control, pharmacovigilance) is a critical operational and cost factor for manufacturers.

Frequently Asked Questions

1. What is the primary reason for the ongoing demand for N-acetylcysteine 10% inhalation solution? The persistent demand is driven by the high global prevalence of respiratory diseases like COPD and cystic fibrosis, which generate significant mucus, and NAC's proven efficacy as a mucolytic agent in breaking down this thick mucus.

2. How does the generic status of NDC 63044-0484 impact its pricing compared to a branded equivalent? As a generic drug, NDC 63044-0484 faces direct price competition from multiple manufacturers, leading to significantly lower net prices compared to any potential branded or originator product, which would have benefited from market exclusivity periods.

3. What is the most significant cost driver for manufacturers of sterile inhalation solutions like NDC 63044-0484? The most significant cost drivers are the overhead associated with maintaining sterile manufacturing facilities, stringent quality control measures required by regulatory bodies, and the cost of the active pharmaceutical ingredient (API) itself.

4. Could future regulatory changes significantly impact the price of NDC 63044-0484? Yes, if regulatory agencies implement stricter quality standards, new testing requirements, or mandate changes to manufacturing processes that increase production costs, these could be passed on to consumers in the form of higher prices.

5. Are there any emerging threats or opportunities in the market for N-acetylcysteine inhalation solutions that could affect future pricing or demand? Emerging opportunities include research into potential new therapeutic uses for NAC. Threats could include the development of superior, next-generation mucolytic agents that prove more effective or convenient, potentially cannibalizing demand for NAC, or significant disruptions in the global supply chain for key raw materials.

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Citations

[1] Grand View Research. (2023). N-Acetylcysteine Market Size, Share & Trends Analysis Report By Product, By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/n-acetylcysteine-market [2] World Health Organization. (2020). Pneumonia. Retrieved from https://www.who.int/news-room/fact-sheets/detail/pneumonia [3] World Health Organization. (2022). Chronic obstructive pulmonary disease (COPD). Retrieved from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)