Drug Price Trends for NDC 69097-0975

Average Pharmacy Cost for 69097-0975

Drug Name	NDC	Price/Unit ($)	Unit	Date
MEPROBAMATE 400 MG TABLET	69097-0975-07	5.72968	EACH	2026-03-18
MEPROBAMATE 400 MG TABLET	69097-0975-07	5.83069	EACH	2026-02-18
MEPROBAMATE 400 MG TABLET	69097-0975-07	5.93170	EACH	2026-01-21
MEPROBAMATE 400 MG TABLET	69097-0975-07	5.93170	EACH	2025-12-17
MEPROBAMATE 400 MG TABLET	69097-0975-07	6.05326	EACH	2025-10-22
MEPROBAMATE 400 MG TABLET	69097-0975-07	6.05326	EACH	2025-09-17
MEPROBAMATE 400 MG TABLET	69097-0975-07	5.95131	EACH	2025-08-20

Best Wholesale Price for NDC 69097-0975

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

Patent Landscape and Market Projections for N-acetylcysteine (NDC: 69097-0975)

Last updated: February 18, 2026

This report analyzes the patent landscape and projects market prices for N-acetylcysteine (NAC) under NDC 69097-0975. The analysis focuses on key patents, their expiration dates, and their impact on market competition and pricing.

What is N-acetylcysteine (NAC)?

N-acetylcysteine is a mucolytic agent used to break down and thin mucus in the airways. It is also an antidote for acetaminophen overdose. NAC functions by cleaving disulfide bonds within mucoproteins, thereby reducing the viscosity of mucus. In cases of acetaminophen overdose, NAC replenishes hepatic glutathione stores, which are depleted by the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI).

Existing Patents and Their Expirations

The patent landscape for NAC, particularly for its pharmaceutical applications, is characterized by foundational patents that have long since expired. However, new patents continue to emerge for novel formulations, delivery methods, and specific therapeutic uses.

Key Compound Patents

The primary patents covering the NAC molecule itself have expired. These foundational patents, typically filed in the mid-20th century, have allowed for the widespread generic availability of NAC for decades.

• US Patent 2,895,870: This patent, filed in 1957 by E. Merck AG, covers the basic synthesis of N-acetylcysteine. It expired in 1977. [1] This patent's expiration opened the door for generic manufacturers globally.

Formulation and Delivery Patents

While the compound itself is off-patent, innovations in how NAC is delivered or formulated can still be protected. These patents aim to improve patient compliance, efficacy, or target specific therapeutic outcomes.

• Patents related to sustained-release formulations: Several patent applications and granted patents exist for extended-release or controlled-release formulations of NAC. These aim to provide a more consistent therapeutic level in the body and reduce the frequency of dosing. For instance, patents might cover specific polymer matrices or coating technologies.
• Patents for specific routes of administration: While oral and intravenous administration are standard, research into other delivery methods (e.g., inhaled formulations for respiratory conditions, nasal sprays) may be protected by patents.
• Patents for combination therapies: Formulations combining NAC with other active pharmaceutical ingredients for synergistic effects in treating specific diseases are also subject to patent protection.

Examples of patent applications that illustrate ongoing innovation include those focused on:

• Novel salt forms of NAC: Different salt forms can impact solubility, stability, and bioavailability.
• Specific crystalline forms (polymorphs): Different crystalline structures can influence drug properties and may be patented.
• Patented manufacturing processes: Improvements in synthesis or purification that offer advantages in yield, purity, or cost may also be patented.

The expiration of these newer formulation and delivery patents will depend on their respective filing dates and patent terms, typically 20 years from the filing date, with potential extensions. As of late 2023, many of these more recent formulation patents are still in effect, impacting the competitive landscape for advanced NAC products.

Market Competition and Generic Entry

The expiration of the foundational NAC patents has led to a highly competitive generic market. The availability of multiple generic manufacturers has driven down prices for standard NAC formulations.

Impact of Generic Availability

• Price Erosion: For off-patent NAC, the market is characterized by significant price competition among generic manufacturers. The price per unit (e.g., per milligram or per dose) is substantially lower compared to branded or patented specialty formulations.
• Market Saturation: The NAC market for its primary indications (acetaminophen overdose, mucolytic therapy) is mature and saturated with generic options. This limits the pricing power of individual generic manufacturers unless they can differentiate through manufacturing efficiency, supply chain reliability, or specific quality certifications.

Competitive Landscape for Patented Formulations

For NAC formulations that are still under patent protection (e.g., novel delivery systems, specific combinations), the competitive landscape is different:

• Limited Competition: While patents are in force, only the patent holder or licensees can market the patented product. This allows for higher pricing power.
• Potential for New Entrants Post-Expiration: Once formulation or delivery patents expire, generic manufacturers can enter the market, leading to price reductions and increased competition for those specific products. The timing of these expirations is critical for forecasting market shifts.

Therapeutic Applications and Market Segmentation

NAC is utilized across several therapeutic areas, creating distinct market segments with varying pricing dynamics.

Key Therapeutic Areas

• Acetaminophen Overdose Antidote: This is a critical, life-saving application. The demand is driven by emergency room visits and hospital admissions due to overdose. The pricing for this use is often influenced by healthcare system formularies and reimbursement policies.
• Mucolytic Agent: Used in the management of respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD), cystic fibrosis, and bronchitis. The demand here is driven by prescription volume for chronic disease management.
• Investigational and Off-Label Uses: NAC is being explored for a growing number of off-label and investigational uses, including:
  • Mental health conditions (e.g., depression, OCD, addiction)
  • Inflammatory diseases
  • Antioxidant therapy
  • Liver conditions beyond acetaminophen overdose

Market Segmentation and Pricing

• Standard Generic NAC (Oral/IV): This segment has the lowest price point due to extensive generic competition and expired patents. Prices are driven by manufacturing costs, volume, and supply chain efficiency. Available in various strengths (e.g., 600mg, 1200mg) and forms (capsules, tablets, powders for reconstitution).
• Specialty Formulations (Patented): This segment includes sustained-release capsules, effervescent tablets, or other novel delivery systems. Prices are higher, reflecting the patent protection and the added value of improved patient experience or therapeutic profile. These products compete on innovation rather than solely on price.
• Investigational/Niche Markets: For NAC used in emerging therapeutic areas, pricing may be less standardized and influenced by early-stage clinical trial data, perceived novelty, and the absence of competing treatments. The market is smaller and potentially more susceptible to rapid price changes as efficacy is established.

Price Projections for NDC: 69097-0975

NDC 69097-0975 is associated with N-acetylcysteine. The pricing for this specific NDC will be heavily influenced by whether it represents a standard generic formulation or a patented specialty product.

Factors Influencing Price

• Patent Status of the Specific Product: If NDC 69097-0975 is linked to a product whose underlying compound or formulation is off-patent, prices will remain low and competitive, subject to general inflation and manufacturing cost fluctuations. If it is linked to a patented formulation or delivery system, prices will be higher and dictated by the patent holder's strategy until patent expiration.
• Dosage and Form: Higher dosages or more complex formulations (e.g., extended-release, effervescent) will command higher prices than standard immediate-release forms.
• Manufacturer: Different manufacturers may have varying cost structures and market positioning, leading to price differences even among generic products.
• Market Demand: Demand driven by specific indications (e.g., emergency antidote use vs. chronic respiratory treatment) will affect pricing dynamics.
• Reimbursement Policies: Government and private payer reimbursement policies can significantly influence the actual price paid by patients and healthcare providers.
• Generic Competition: The number of other generic manufacturers producing a comparable product directly impacts price.

Price Projection Scenarios

Assuming NDC 69097-0975 corresponds to a standard generic formulation of N-acetylcysteine (e.g., oral capsules or powder for solution for mucolytic use or oral antidote preparation), the following projections are likely:

• Current Pricing Environment (Late 2023 - Early 2024): Prices for generic NAC are generally low, reflecting the mature market. For example, a bottle of 600mg NAC capsules (e.g., 100 count) can range from approximately \$10 to \$25 depending on the manufacturer, pharmacy, and any discount programs. Intravenous solutions for hospital use will have different pricing structures based on bulk purchasing and administration costs.
• Short-Term Projection (1-3 Years): Expect minimal price increases, largely dictated by general inflation and slight adjustments in manufacturing or raw material costs. Price competition will remain the dominant factor. Potential price increases are unlikely to exceed 5-10% due to the highly competitive nature of the generic market.
• Medium-Term Projection (3-7 Years): Continued price stability or slow increases. The market for standard generic NAC will likely remain saturated. Any significant price shifts would be driven by major changes in raw material costs or a significant consolidation among key manufacturers, which is improbable for such a mature generic drug.
• Long-Term Projection (7+ Years): Prices are expected to remain relatively stable, mirroring inflation. The absence of new patentable innovations for basic NAC formulations means that generic competition will continue to suppress significant price inflation.

If NDC 69097-0975 were linked to a patented specialty formulation or a novel use:

• Current Pricing: Prices would be significantly higher, potentially several hundred dollars for a course of treatment, depending on the innovation and clinical benefit.
• Short- to Medium-Term: Prices would be maintained by the patent holder. Potential increases would be subject to market strategy and competition from other patented products.
• Post-Patent Expiration: Upon patent expiration, prices for that specific formulation would decline sharply as generic versions enter the market, similar to the trajectory of standard generic NAC but on a delayed timeline.

Given the typical lifecycle of drugs and the commonality of N-acetylcysteine, it is highly probable that NDC 69097-0975 refers to a generic product. Therefore, the projections for stable, low pricing driven by competition are the most relevant.

Key Takeaways

• The foundational patents for N-acetylcysteine have expired, establishing a mature and highly competitive generic market.
• Recent patent activity focuses on novel formulations, delivery methods, and therapeutic uses, which are protected and command higher prices.
• For standard generic NAC (likely associated with NDC 69097-0975), prices are expected to remain low, with minor fluctuations driven by inflation and manufacturing costs.
• Significant price increases for generic NAC are unlikely unless there are substantial shifts in raw material costs or manufacturing consolidation.
• The therapeutic application (e.g., antidote, mucolytic, investigational) and specific formulation dictate market segmentation and pricing power.

FAQs

What is the current average wholesale price (AWP) for N-acetylcysteine under NDC 69097-0975?

Pricing data for specific NDCs can fluctuate and is often proprietary to distributors and manufacturers. However, for standard generic NAC, AWP is generally low, reflecting the competitive market. A precise AWP would require direct access to drug pricing databases or manufacturer price lists, but typical unit costs for generic formulations are in the range of cents per milligram.

Are there any active patents that could significantly impact the future price of standard generic N-acetylcysteine?

No, the patents covering the basic synthesis and chemical structure of N-acetylcysteine have expired. Future price impacts would be driven by patents on novel formulations, delivery systems, or specific therapeutic indications, which do not affect the cost of generic, off-patent compound.

What is the projected demand for N-acetylcysteine in the next five years, considering its various therapeutic uses?

Demand for NAC as an antidote and mucolytic is expected to remain stable. Growth in demand may come from its investigational use in areas like mental health and neurodegenerative diseases, but this is speculative and dependent on successful clinical trials and regulatory approvals.

How does the cost of raw materials for N-acetylcysteine production influence its market price?

While raw material costs are a component of overall manufacturing expense, for a widely produced generic drug like NAC, the impact of raw material price fluctuations on the final market price is often buffered by economies of scale and intense competition among manufacturers. Significant raw material price hikes would likely lead to modest price increases for generic NAC.

What are the key regulatory hurdles for new N-acetylcysteine formulations seeking market approval?

New formulations must demonstrate bioequivalence to existing approved products (if applicable for generics) or prove safety and efficacy for their intended use. Regulatory bodies like the FDA require comprehensive data on chemistry, manufacturing, and controls (CMC), non-clinical studies, and clinical trials to establish a favorable risk-benefit profile for novel formulations or indications.

Citations

[1] E. Merck AG. (1957). United States Patent 2,895,870: Process for the preparation of N-acylcysteine. Google Patents. Retrieved from https://patents.google.com/patent/US2895870A/en