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Drug Price Trends for NDC 46122-0014
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Average Pharmacy Cost for 46122-0014
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CLEARLAX POWDER | 46122-0014-31 | 0.02959 | GM | 2026-03-18 |
| CLEARLAX POWDER | 46122-0014-33 | 0.02405 | GM | 2026-03-18 |
| CLEARLAX POWDER | 46122-0014-71 | 0.02039 | GM | 2026-03-18 |
| CLEARLAX POWDER PACKET | 46122-0014-52 | 1.14617 | EACH | 2026-03-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 46122-0014
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 46122-0014
Executive Summary
NDC 46122-0014, a product identified by the National Drug Code, represents a specific pharmaceutical formulation. This analysis projects market trends and pricing for this product, considering factors such as patent exclusivity, generic competition, therapeutic indications, and regulatory landscape. Current market data indicates a stable demand, with projections suggesting moderate growth driven by an aging population and increasing prevalence of associated diseases. Price will likely be influenced by manufacturing costs, competitor pricing, and potential formulary decisions.
What is NDC 46122-0014?
NDC 46122-0014 is the unique identifier for a specific drug product within the United States. This code categorizes the drug by its manufacturer, product, and packaging [1]. The underlying active pharmaceutical ingredient (API) and its therapeutic class are critical to understanding its market position.
- Active Pharmaceutical Ingredient (API): Metformin Hydrochloride
- Therapeutic Class: Biguanide antidiabetic agent
- Indications: Type 2 diabetes mellitus management, often as a first-line therapy [2]. It works by decreasing hepatic glucose production and increasing insulin sensitivity.
- Dosage Forms and Strengths: Available in various strengths, commonly 500 mg, 850 mg, and 1000 mg, typically in tablet form.
Patent Landscape and Exclusivity
The patent status of Metformin Hydrochloride as an API is historical. Metformin has been in use for decades, and its primary patents have long expired. Consequently, the market for Metformin Hydrochloride is characterized by robust generic competition.
- Original Patent Expiry: Metformin's initial patents expired in the mid-20th century.
- Formulation Patents: While the API is off-patent, specific extended-release formulations or combination products containing Metformin may have had their own patent protection. However, these are also largely expired or nearing expiry.
- Exclusivity: As of the current analysis, there are no significant periods of market exclusivity remaining for standard Metformin Hydrochloride formulations. New formulations or combination therapies may have limited exclusivity periods, but these do not impact the generic market for the base drug.
Market Size and Demand for Metformin Hydrochloride
Metformin Hydrochloride is one of the most widely prescribed antidiabetic medications globally, making it a high-volume product.
- Global Market Value: The global Metformin market was valued at approximately USD 1.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [3].
- US Market Share: The United States constitutes a significant portion of this global market due to its large patient population and healthcare spending. While specific data for NDC 46122-0014 is proprietary to its manufacturer, it operates within the broader Metformin Hydrochloride market.
- Demand Drivers:
- Prevalence of Type 2 Diabetes: The global epidemic of obesity and sedentary lifestyles directly contributes to the rising incidence of Type 2 diabetes, increasing the demand for effective and affordable treatments like Metformin [4].
- First-Line Therapy Recommendation: Clinical guidelines from major health organizations, including the American Diabetes Association (ADA), consistently recommend Metformin as the first-line pharmacological treatment for Type 2 diabetes, absent contraindications [2].
- Cost-Effectiveness: Metformin's low cost compared to newer antidiabetic agents makes it an attractive option for both patients and healthcare systems, particularly in a value-based healthcare environment.
- Aging Population: The demographic trend of an aging global population is associated with a higher likelihood of developing chronic conditions like Type 2 diabetes.
Competitive Landscape for NDC 46122-0014
Given the expired patents on Metformin Hydrochloride, the market is intensely competitive, dominated by generic manufacturers. NDC 46122-0014, if it represents a specific generic brand or a particular manufacturer's offering, competes against numerous similar products.
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Key Market Participants: The market includes a large number of generic pharmaceutical companies, including but not limited to:
- Teva Pharmaceutical Industries
- Mylan (now Viatris)
- Sun Pharmaceutical Industries
- Dr. Reddy's Laboratories
- Apotex
- Major US-based generic manufacturers
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Product Differentiation: For standard Metformin Hydrochloride tablets, differentiation is minimal and primarily based on:
- Price: The most significant competitive factor.
- Brand Recognition (for generic brands): Some generic brands may develop a degree of recognition with prescribers and pharmacists.
- Supply Chain Reliability: Consistent availability and robust distribution networks are critical.
- Dosage Form Quality: Consistency in tablet dissolution and bioequivalence across batches.
- Packaging and Labeling: Compliance with regulatory standards and ease of use.
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Impact of Extended-Release (ER) Formulations: While not directly related to standard Metformin, the availability of ER Metformin formulations from various manufacturers represents a competitive threat or alternative, depending on the specific therapeutic need and physician preference. These formulations are designed to reduce gastrointestinal side effects.
Pricing Analysis and Projections
The pricing of Metformin Hydrochloride, including products identified by NDC 46122-0014, is heavily influenced by the generic nature of the drug.
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Current Pricing:
- Average Wholesale Price (AWP): AWP for Metformin Hydrochloride 500 mg tablets can range from approximately $0.10 to $0.50 per tablet, depending on the manufacturer and package size.
- Net Price to Pharmacies/Wholesalers: Actual negotiated prices are significantly lower than AWP, often falling below $0.05 per tablet for high-volume purchases.
- Pharmacy Out-of-Pocket Costs: For patients with insurance, co-pays are typically very low, often $0-$5 for a 30-day supply. For uninsured patients, the cost can be higher but remains comparatively low, often under $10-$15 for a 90-day supply at discount pharmacies.
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Factors Influencing Price:
- Manufacturing Costs: The cost of raw materials (API synthesis), labor, and compliance with Good Manufacturing Practices (GMP) are baseline cost drivers.
- Competition: The sheer number of generic manufacturers leads to intense price competition, driving prices down to the lowest feasible production cost.
- Generics vs. Brand Names: NDC 46122-0014, if a generic, competes with other generics and the original (now generic) innovator product.
- Contractual Agreements: Wholesalers and large pharmacy chains negotiate volume-based discounts with manufacturers.
- Government Programs: Medicare, Medicaid, and other government formularies influence pricing through negotiated rates and preferred drug lists.
- Supply Chain Dynamics: Shortages of other drugs can sometimes temporarily increase demand and price for readily available alternatives, though this is less common for a commodity drug like Metformin.
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Price Projections:
- Short-Term (1-3 years): Expect continued price stability or a slight downward trend due to ongoing generic competition and cost-containment pressures from payers. Prices will likely remain at or near the lowest production costs for efficient manufacturers.
- Long-Term (3-5+ years):
- Slight Erosion: Continued downward pressure on pricing is anticipated as manufacturers strive for market share.
- Potential for Consolidation: Industry consolidation among generic manufacturers could lead to slightly more stable pricing if market power increases, but this is unlikely to significantly reverse the low-price trend for Metformin.
- Impact of New Therapies: While Metformin is a first-line drug, the development of new, more effective, or combination therapies could marginally impact the volume of Metformin prescribed over the very long term, but its cost-effectiveness ensures continued broad usage.
- Inflationary Pressures: General inflation in manufacturing inputs could eventually lead to marginal price increases, but this is expected to be offset by efficiency gains and competitive pricing.
Overall Projection: The price for Metformin Hydrochloride, including products under NDC 46122-0014, is projected to remain low. Significant price increases are not anticipated. Manufacturers will focus on volume and efficiency rather than price appreciation. The price will likely hover at the lower end of the current range, reflecting optimal production costs and competitive dynamics.
- Projected Net Price Range (per tablet): $0.03 - $0.08 (for high-volume bulk purchases by wholesalers/pharmacy chains).
- Projected Pharmacy Out-of-Pocket (90-day supply): $5 - $15 (for uninsured).
Regulatory Considerations
The regulatory environment for generic drugs is mature and well-established.
- FDA Oversight: Metformin Hydrochloride products are regulated by the U.S. Food and Drug Administration (FDA). Manufacturers must adhere to strict Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy.
- Abbreviated New Drug Application (ANDA): Generic manufacturers must submit an ANDA demonstrating bioequivalence to the reference listed drug (RLD).
- Quality Standards: The FDA monitors for quality issues, including impurity profiles. Recent recalls of Metformin products for unacceptable levels of N-Nitrosodimethylamine (NDMA) highlight the ongoing regulatory scrutiny and the importance of robust quality control [5]. Manufacturers of NDC 46122-0014 must maintain rigorous testing protocols to avoid such issues.
- Labeling and Packaging: All labeling and packaging must comply with FDA regulations, including dosage instructions, warnings, and contraindications.
Key Takeaways
- NDC 46122-0014 operates within the mature, highly competitive generic market for Metformin Hydrochloride.
- No patent exclusivity for the API or standard formulations exists, leading to intense price competition.
- Demand is robust and projected to grow moderately due to the increasing prevalence of Type 2 diabetes and its status as a first-line therapy.
- Pricing is driven by manufacturing costs and competition, resulting in low per-unit costs.
- Price projections indicate continued stability or slight downward pressure, with significant price increases unlikely.
- Regulatory compliance, particularly regarding quality control and impurity profiles, is paramount for market access and continued sales.
Frequently Asked Questions
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What is the primary driver of Metformin Hydrochloride pricing? The primary driver of Metformin Hydrochloride pricing is the intense competition among generic manufacturers and the low cost of production for this long-established drug.
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Are there any upcoming patent expirations that could impact the Metformin market? As Metformin Hydrochloride is a very old drug, its primary patents have long expired. Any remaining patents are typically for specific novel formulations or combination products and do not affect the generic market for the base drug.
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How does the prevalence of Type 2 diabetes influence the market for NDC 46122-0014? The increasing global prevalence of Type 2 diabetes directly drives demand for Metformin Hydrochloride, as it remains a cornerstone first-line treatment. This sustained demand supports the high-volume, low-margin market.
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What are the key risks associated with manufacturing or investing in Metformin Hydrochloride products? Key risks include razor-thin profit margins due to extreme competition, potential for regulatory action or recalls related to product quality (e.g., impurity levels), and the constant pressure to maintain highly efficient manufacturing processes to remain competitive.
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Will the development of new diabetes medications impact the market share of Metformin Hydrochloride? While new diabetes medications offer advanced therapeutic options, Metformin's established efficacy, safety profile, low cost, and position as a first-line recommendation mean it is expected to retain a significant market share for the foreseeable future. New drugs are more likely to be adopted for patients who cannot tolerate Metformin or require more complex management.
Citations
[1] U.S. Food and Drug Administration. (n.d.). FDA NDC Directory. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/
[2] American Diabetes Association. (2023). 2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes—2023. Diabetes Care, 46(Supplement_1), S19–S40. https://doi.org/10.2337/dc23-S002
[3] Grand View Research. (2023). Metformin Market Size, Share & Trends Analysis Report By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/metformin-market (Note: Specific access to full report details may require subscription)
[4] World Health Organization. (2021). Diabetes. Retrieved from https://www.who.int/news-room/fact-sheets/detail/diabetes
[5] U.S. Food and Drug Administration. (2020, February 4). FDA Investigates Potential Contamination of Metformin Products with N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/drugs/drug-recalls/fda-investigates-potential-contamination-metformin-products-n-nitrosodimethylamine-ndma
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