Drug Price Trends for NDC 31722-0535

Average Pharmacy Cost for 31722-0535

Drug Name	NDC	Price/Unit ($)	Unit	Date
TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLET	31722-0535-30	0.33143	EACH	2026-03-18
TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLET	31722-0535-30	0.31866	EACH	2026-02-18
TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLET	31722-0535-30	0.34625	EACH	2026-01-21
TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLET	31722-0535-30	0.34668	EACH	2025-12-17

Best Wholesale Price for NDC 31722-0535

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: 31722-0535

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing for the pharmaceutical product identified by National Drug Code (NDC) 31722-0535. The analysis considers current market dynamics, patent expirations, generic competition, and regulatory factors influencing future price trajectories.

What is NDC: 31722-0535?

NDC 31722-0535 corresponds to Metformin Hydrochloride Tablets, 1000 mg, a widely prescribed oral antidiabetic medication. It belongs to the biguanide class of drugs and is primarily used to treat type 2 diabetes mellitus [1]. Metformin works by decreasing glucose production in the liver, decreasing intestinal absorption of glucose, and improving insulin sensitivity. It is a first-line therapy for many patients with type 2 diabetes [2].

Current Market Landscape for Metformin Hydrochloride 1000 mg

Metformin Hydrochloride is a mature drug with a well-established market presence. The 1000 mg dosage strength is a common formulation, catering to patients requiring higher daily doses.

Key Market Characteristics:

• High Prescription Volume: Metformin is one of the most prescribed medications globally for type 2 diabetes. Its efficacy, safety profile, and affordability contribute to its widespread use [3].
• Generic Availability: Metformin has been off-patent for many years, leading to a highly competitive generic market. Numerous pharmaceutical manufacturers produce generic versions of Metformin Hydrochloride tablets.
• Price Sensitivity: Due to its generic status and high volume, Metformin is a price-sensitive product. Reimbursement policies and competitive bidding significantly influence its market price.
• Formulation Variety: While this analysis focuses on 1000 mg tablets, Metformin is available in various strengths (e.g., 500 mg, 850 mg) and formulations, including immediate-release and extended-release versions.
• Therapeutic Guidelines: Major medical organizations, such as the American Diabetes Association, recommend Metformin as a first-line treatment for type 2 diabetes unless contraindicated [4]. This continued endorsement sustains demand.

Major Manufacturers and Market Share:

The market for Metformin Hydrochloride 1000 mg is fragmented, with no single entity holding a dominant market share. Major generic manufacturers operating in the United States include but are not limited to:

• Teva Pharmaceuticals
• Mylan (now Viatris)
• Aurobindo Pharma
• Lupin Pharmaceuticals
• Amneal Pharmaceuticals
• Breckenridge Pharmaceutical

These companies, along with many others, contribute to the intense competition, which typically drives down prices. The market share data is dynamic and often proprietary, but the presence of numerous suppliers indicates a highly competitive environment.

Patent Status and Exclusivity for Metformin Hydrochloride

Metformin Hydrochloride is a well-established drug whose primary patents expired decades ago. The original patents for Metformin hydrochloride were granted in the late 1950s and early 1960s.

Patent Expiration Timeline:

• Original Composition of Matter Patents: Expired in the 1970s and 1980s.
• Formulation and Manufacturing Process Patents: While newer patents related to specific formulations (e.g., extended-release) or manufacturing processes may exist, the core immediate-release 1000 mg tablet is no longer protected by market exclusivity due to expired foundational patents.

The absence of patent protection for the active pharmaceutical ingredient (API) and standard immediate-release formulations means that generic manufacturers can produce and market these products without licensing fees related to the original patent.

Regulatory and Reimbursement Factors

Regulatory approvals and reimbursement policies play a significant role in the pricing and accessibility of Metformin Hydrochloride.

FDA Approval and Generics:

The U.S. Food and Drug Administration (FDA) approves generic drug applications (ANDAs) for Metformin Hydrochloride. Approval signifies that the generic product is bioequivalent to the reference listed drug and meets quality and safety standards. The presence of multiple FDA-approved generics underscores the competitive nature of the market.

Reimbursement Landscape:

• Medicare and Medicaid: These government programs are significant payers for Metformin. Reimbursement rates are often set through competitive bidding processes and formularies, which exert downward pressure on prices.
• Commercial Insurers: Private health insurance plans also cover Metformin. Payer formularies typically list Metformin as a preferred or tier-1 drug due to its low cost and efficacy, further incentivizing its use and keeping prices competitive.
• Pharmacy Benefit Managers (PBMs): PBMs negotiate drug prices on behalf of health plans and employers. Their role in managing formularies and rebates contributes to the overall pricing structure.

The general policy across payers is to favor low-cost, high-efficacy generics for commonly prescribed medications like Metformin.

Price Projections for Metformin Hydrochloride 1000 mg

Given the mature market, extensive generic competition, and the drug's status as a cost-effective therapy, price projections for Metformin Hydrochloride 1000 mg indicate continued stability with modest fluctuations.

Current Pricing Trends:

• Wholesale Acquisition Cost (WAC): WAC prices for Metformin Hydrochloride 1000 mg tablets typically range from $0.10 to $0.50 per tablet, depending on the manufacturer, packaging size, and contracted discounts.
• Average Wholesale Price (AWP): AWP, a benchmark price, may be higher, but actual transactional prices are significantly lower due to rebates and discounts negotiated by payers and PBMs.
• Net Price: The net price paid by wholesalers and distributors, after accounting for all discounts and rebates, is considerably lower than WAC or AWP and is the most relevant indicator of market competitiveness.

Factors Influencing Future Pricing:

1. Continued Generic Competition: The market will remain populated by numerous generic manufacturers. This ensures that pricing remains highly competitive. No new entrants are expected to disrupt this dynamic significantly, as the barriers to entry for generic Metformin production are low.
2. Cost of API and Manufacturing: Fluctuations in the cost of raw materials (active pharmaceutical ingredient - API) and manufacturing overhead can cause minor price variations. However, the scale of Metformin production globally generally buffers significant cost shocks.
3. Payer Negotiations and Formulary Management: Ongoing negotiations between manufacturers, PBMs, and payers will continue to shape net prices. Payers will likely maintain Metformin on preferred tiers, leveraging its low cost.
4. Increased Demand: The prevalence of type 2 diabetes continues to rise globally. This sustained and potentially increasing demand could provide some limited upward pressure, but it is unlikely to outweigh the competitive pricing pressures.
5. Emergence of New Diabetes Treatments: While Metformin remains a first-line agent, the development of novel diabetes medications (e.g., GLP-1 receptor agonists, SGLT2 inhibitors) could indirectly impact Metformin's market share in specific patient populations. However, Metformin's cost-effectiveness ensures its continued broad use.

Projected Price Range (2024-2028):

Year	Projected Net Price per Tablet (USD)	Notes
2024	$0.10 - $0.30	Stable pricing driven by established generic competition.
2025	$0.10 - $0.32	Minor adjustments due to manufacturing costs and payer bids.
2026	$0.10 - $0.33	Continued price erosion or stability.
2027	$0.11 - $0.34	Potential for slight upward pressure from demand, offset by competition.
2028	$0.11 - $0.35	Long-term projection maintains competitive pricing.

Source: Analyst Projections based on market data analysis.

Important Note: These projections represent net prices after discounts and rebates, which are the most relevant figures for understanding the true market cost. WAC and AWP will remain higher but are less indicative of actual transactional prices.

Competitive Analysis of Metformin Hydrochloride 1000 mg Market

The competitive landscape for Metformin Hydrochloride 1000 mg is characterized by a high degree of fragmentation and intense price competition among generic manufacturers.

Key Competitive Factors:

• Number of Suppliers: A large number of generic manufacturers produce Metformin HCl 1000 mg. This prevents any single entity from significantly influencing market prices.
• Manufacturing Efficiency: Manufacturers with efficient production processes and access to cost-effective API sources can achieve lower per-unit costs, enabling them to compete more aggressively on price.
• Distribution Networks and Contracts: Established relationships with wholesalers, distributors, and large pharmacy chains are crucial. Companies with strong distribution networks can secure larger contracts and higher sales volumes.
• Quality and Compliance: Maintaining high manufacturing standards and complying with FDA regulations is essential. Any quality issues or recalls can severely damage a manufacturer's market position.
• Rebate Strategies: While prices are low, manufacturers may engage in rebate strategies to secure preferred formulary placement or capture market share.

Barriers to Entry:

• Regulatory Hurdles: While the drug is off-patent, obtaining FDA approval for an ANDA requires significant investment in clinical trials (bioequivalence studies), manufacturing facilities, and quality control.
• Scale of Production: To compete effectively on price, manufacturers need to achieve significant economies of scale. Smaller players may struggle to match the cost efficiencies of larger, established generic companies.
• Established Relationships: Securing contracts with major payers and distributors can be challenging for new entrants due to the established relationships of incumbent players.

The market is unlikely to see significant shifts in its competitive structure unless there are major changes in manufacturing costs, regulatory policies, or the emergence of a disruptive new therapeutic approach that fundamentally alters Metformin's role.

Potential Risks and Opportunities

Risks:

• Further Price Erosion: Continued aggressive bidding by payers and manufacturers could lead to net prices falling below current projections.
• Supply Chain Disruptions: Global supply chain issues, geopolitical instability, or API shortages could impact manufacturing costs and availability, though Metformin's widespread sourcing may mitigate this.
• Increased Scrutiny on Generics: Regulatory bodies or policymakers could increase scrutiny on generic drug pricing practices, potentially leading to new regulations that affect profitability.
• Shift to Newer Diabetes Therapies: A more rapid-than-expected shift by physicians and patients to newer, more expensive diabetes medications could marginally reduce overall demand for Metformin over the long term, although its cost advantage is likely to preserve its first-line status for many years.

Opportunities:

• Market Expansion in Developing Economies: As healthcare access improves in developing countries, the demand for affordable and effective treatments like Metformin is expected to grow.
• Optimization of Manufacturing Processes: Manufacturers that can further optimize their production and supply chain could achieve cost advantages, leading to improved margins even in a low-price environment.
• Focus on Extended-Release or Combination Products: While the immediate-release 1000 mg tablet is highly competitive, opportunities might exist for manufacturers to differentiate through improved extended-release formulations or combination products, though patenting these can be complex.
• Contract Manufacturing: Companies with strong manufacturing capabilities could leverage opportunities to act as contract manufacturers for other generic companies.

Key Takeaways

• Metformin Hydrochloride 1000 mg (NDC: 31722-0535) is a mature, off-patent drug with a highly competitive generic market.
• The market is characterized by numerous suppliers, intense price pressure, and significant influence from payer reimbursement policies and PBM negotiations.
• Net prices are projected to remain stable to slightly declining, with a projected range of $0.10-$0.35 per tablet through 2028, driven by ongoing generic competition.
• Manufacturing efficiency, distribution networks, and adherence to regulatory standards are critical competitive factors.
• While risks of further price erosion exist, opportunities for market growth in developing regions and process optimization remain.

Frequently Asked Questions

1. What is the primary driver of Metformin Hydrochloride's price? The primary driver of Metformin Hydrochloride's price is the intense competition among a large number of generic manufacturers, coupled with payer negotiations and formulary management by Pharmacy Benefit Managers.

2. Are there any upcoming patent expirations that could impact Metformin Hydrochloride 1000 mg? No, the foundational patents for Metformin Hydrochloride have long expired. Any new patents would likely pertain to specific novel formulations or manufacturing processes, which do not affect the standard immediate-release 1000 mg tablet.

3. How does the price of Metformin Hydrochloride 1000 mg compare to other diabetes medications? Metformin Hydrochloride 1000 mg is significantly less expensive than newer classes of diabetes medications such as GLP-1 receptor agonists or SGLT2 inhibitors. It remains one of the most cost-effective treatments available for type 2 diabetes.

4. What is the projected impact of increased type 2 diabetes prevalence on Metformin pricing? While an increasing prevalence of type 2 diabetes is likely to sustain or increase demand for Metformin, this demand is generally expected to be met by existing generic supply. The competitive nature of the market means increased demand is unlikely to lead to significant price increases; instead, it reinforces the stable market for this essential medication.

5. What are the key factors that would cause Metformin Hydrochloride 1000 mg prices to deviate significantly from current projections? Significant deviations would likely arise from major global supply chain disruptions impacting API costs, unexpected regulatory changes affecting generic drug manufacturing or pricing, or a rapid and widespread adoption of alternative therapies that drastically reduces Metformin's market share, which is currently unlikely for first-line treatment.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Metformin Hydrochloride Tablets. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40355f7a-253a-481c-80b6-929c9541c465

[2] American Diabetes Association. (2023). Standards of care in diabetes—2023. Diabetes Care, 46(Supplement_1).

[3] Tan, M. H., Yung, R., Hong, Y., & Yeo, S. (2016). Metformin: A review of its current role in the management of type 2 diabetes. Current Diabetes Reviews, 12(3), 327-334.

[4] American Diabetes Association. (2024). Standards of Care in Diabetes—2024. Diabetes Care, 47(Supplement_1).