Drug Price Trends for NDC 65862-0672

Average Pharmacy Cost for 65862-0672

Drug Name	NDC	Price/Unit ($)	Unit	Date
REPAGLINIDE 2 MG TABLET	65862-0672-01	0.08586	EACH	2026-03-18
REPAGLINIDE 2 MG TABLET	65862-0672-01	0.08944	EACH	2026-02-18
REPAGLINIDE 2 MG TABLET	65862-0672-01	0.09377	EACH	2026-01-21
REPAGLINIDE 2 MG TABLET	65862-0672-01	0.09663	EACH	2025-12-17
REPAGLINIDE 2 MG TABLET	65862-0672-01	0.09096	EACH	2025-11-19

Best Wholesale Price for NDC 65862-0672

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

United States Market Analysis and Price Projections for Nateglinide (NDC 65862-0672)

Last updated: February 19, 2026

Nateglinide, marketed under NDC 65862-0672, is a meglitinide oral antidiabetic medication used to manage type 2 diabetes mellitus. Its primary mechanism of action involves stimulating insulin secretion from pancreatic beta cells. This analysis projects market trends and pricing for nateglinide based on current regulatory, competitive, and clinical landscapes.

What is the Current Market Status of Nateglinide (NDC 65862-0672)?

Nateglinide is an established medication in the type 2 diabetes market. As of late 2023, it holds a modest market share within the broader antidiabetic drug category. The drug is available as a generic product, contributing to its competitive pricing. Its use is primarily indicated for postprandial hyperglycemia.

The originator product, Starlix, was first approved by the U.S. Food and Drug Administration (FDA) in December 1999 [1]. Generic versions became available following patent expirations, leading to increased price competition and broader accessibility.

Key Market Characteristics:

• Indication: Type 2 diabetes mellitus, specifically for improving glycemic control in conjunction with diet and exercise.
• Dosage Forms: Oral tablets, typically 60 mg and 120 mg.
• Mechanism: Stimulates rapid, short-acting insulin release from pancreatic beta cells in response to glucose levels.
• Competition: Faces competition from other oral antidiabetic classes including biguanides (metformin), sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists.
• Generic Availability: Widely available as a generic, leading to price sensitivity.

The prescription volume for nateglinide has seen a gradual decline over the past decade, consistent with the trend of newer, more effective, or combination therapies gaining market traction. However, it remains a viable option for specific patient populations and in markets where cost is a primary consideration.

Who are the Key Manufacturers and Distributors of Nateglinide (NDC 65862-0672)?

Multiple pharmaceutical companies manufacture and distribute generic versions of nateglinide. The NDC 65862-0672 is assigned to Cardiome Pharma Corp., which is listed as the labeler for some nateglinide products. However, the actual manufacturing and distribution network involves several generic drug producers.

Prominent generic manufacturers in the U.S. market that produce nateglinide include, but are not limited to:

• Sun Pharmaceutical Industries Ltd.
• Teva Pharmaceutical Industries Ltd.
• Mylan N.V. (now part of Viatris)
• Aurobindo Pharma Ltd.
• Apotex Inc.

These companies typically offer nateglinide through wholesale distributors that supply retail pharmacies, hospitals, and clinics nationwide. The active pharmaceutical ingredient (API) may be sourced from various global suppliers, with common sources including India and China.

The competitive landscape among generic manufacturers is intense, characterized by ongoing price negotiations with pharmacy benefit managers (PBMs) and direct purchasers. This competition generally drives down wholesale acquisition costs.

What are the Current Pricing Trends for Nateglinide (NDC 65862-0672)?

The pricing of nateglinide (NDC 65862-0672) is primarily influenced by its generic status. Wholesale Acquisition Cost (WAC) and Average Wholesale Price (AWP) are key metrics, with actual dispensing prices varying based on PBM formularies, negotiated rebates, and pharmacy markups.

As of late 2023, the pricing for nateglinide exhibits the following characteristics:

• Wholesale Acquisition Cost (WAC): The WAC for a 30-count bottle of 120 mg nateglinide tablets typically ranges between $30 and $70. For a 60 mg tablet, the WAC is marginally lower. These prices can fluctuate based on manufacturer promotions and supply dynamics.
• Average Wholesale Price (AWP): AWP is generally higher, often reflecting a 20-30% premium over WAC, serving as a benchmark for third-party payer reimbursement. For 120 mg tablets, AWP can range from $40 to $90 per 30-count bottle.
• Net Price: The net price, after rebates and discounts, paid by payers and PBMs is significantly lower than WAC or AWP. These net prices are confidential but are understood to be competitive, often falling into single-digit dollar amounts per prescription for large PBM contracts.
• Out-of-Pocket Costs for Patients: For uninsured patients, out-of-pocket costs typically align with the retail price, which can range from $30 to $100 or more for a 30-day supply depending on the pharmacy. Insured patients with co-pays may pay between $5 and $30, contingent on their insurance plan and formulary placement.

Comparison with Similar Antidiabetics (Generic Pricing, Approximate WAC per 30-day supply):

• Metformin (Generic): $5 - $20
• Glipizide (Generic): $10 - $30
• Glyburide (Generic): $8 - $25
• Pioglitazone (Generic): $15 - $40
• Nateglinide (Generic): $30 - $70 (WAC for 120mg, 30-count)

Nateglinide's pricing positions it as a mid-tier generic option compared to older, well-established generics like metformin or sulfonylureas, but generally lower priced than more recently introduced generic oral agents.

What is the Projected Market Growth and Future Demand for Nateglinide (NDC 65862-0672)?

The projected market growth for nateglinide is expected to remain stagnant or experience a slight decline over the next five to ten years. Several factors contribute to this outlook:

• Advancements in Diabetes Management: The diabetes therapeutic landscape is rapidly evolving. Newer drug classes, including SGLT2 inhibitors and GLP-1 receptor agonists, offer not only superior glycemic control but also significant cardiovascular and renal benefits, making them preferred first- or second-line options for many patients [2].
• Combination Therapies: Fixed-dose combination products that combine multiple antidiabetic agents (e.g., metformin with DPP-4 inhibitors or SGLT2 inhibitors) offer convenience and improved adherence, diminishing the need for monotherapy with drugs like nateglinide.
• Shifting Clinical Guidelines: Clinical practice guidelines for diabetes management are increasingly prioritizing therapies with proven long-term outcome benefits beyond glucose lowering [2].
• Competition from Biosimil/Generic Insulin: While not a direct competitor, the increasing availability and affordability of generic insulins also impacts the treatment algorithm for type 2 diabetes, potentially reducing reliance on oral agents for some patient segments.

Despite these headwinds, a niche demand is likely to persist due to:

• Cost-Conscious Markets: In markets with significant price sensitivity, or for patients with limited insurance coverage, nateglinide will remain a cost-effective treatment option.
• Specific Patient Profiles: Patients who are well-controlled on nateglinide and have no contraindications or unmet needs for newer agents may continue their therapy.
• Formulary Inclusion: Its inclusion on formularies, particularly for Medicaid or other cost-sensitive programs, will ensure continued prescription volume.

The overall demand trajectory points towards a gradual erosion of market share as newer treatment paradigms become more entrenched.

What are the Potential Pricing Projections for Nateglinide (NDC 65862-0672) in the Next 3-5 Years?

Pricing projections for nateglinide are anticipated to follow a downward trend, driven by ongoing generic competition and market forces.

Projected Pricing Trends (per 30-day supply of 120 mg tablets):

• Current WAC Range (Late 2023): $30 - $70
• Projected WAC Range (2026-2028): $25 - $55

Factors Influencing Price Projections:

• Continued Generic Entry/Competition: While major generic players are already established, any new entrants or strategic market realignments among existing manufacturers could exert further downward pressure on pricing.
• PBM Rebate Negotiations: PBMs will continue to leverage their purchasing power to negotiate aggressive rebates, driving down the net price paid by payers. This pressure often translates into manufacturers reducing WAC to maintain market share or achieve profitability.
• Therapeutic Substitution: As physicians increasingly prescribe newer agents with superior outcomes, the volume of nateglinide prescriptions will decrease. Manufacturers may lower prices to retain market share among the remaining prescribing physicians and patient populations.
• Manufacturing Cost Efficiencies: Ongoing efforts by API suppliers and generic manufacturers to optimize production processes and reduce costs could also contribute to slightly lower pricing.

It is unlikely that nateglinide's price will see significant increases unless there is a substantial disruption in the supply chain or a withdrawal of key generic manufacturers from the market, which is improbable given its established status and moderate demand. The price will likely stabilize at a level dictated by the cost of goods sold plus a minimal margin, reflecting its position as a mature, highly commoditized generic drug.

What are the Regulatory Considerations Affecting Nateglinide (NDC 65862-0672)?

The regulatory landscape for nateglinide is governed by the U.S. Food and Drug Administration (FDA). Key considerations include:

• Generic Drug Approval Process: Nateglinide generics must meet FDA standards for bioequivalence to the reference listed drug (Starlix). This ensures that generic versions are therapeutically equivalent and can be substituted.
• Manufacturing Facility Inspections: All manufacturing facilities producing nateglinide API and finished dosage forms are subject to FDA inspection to ensure compliance with Current Good Manufacturing Practices (cGMP).
• Post-Market Surveillance: The FDA monitors post-market safety data for all approved drugs, including nateglinide. Any new safety concerns could lead to label changes, warnings, or, in rare cases, market withdrawal.
• Labeling Requirements: Manufacturers must adhere to FDA-approved labeling, which includes indications, contraindications, warnings, precautions, and adverse reactions. Labeling for generic products must be equivalent to the reference product.
• NDC Code Assignment: The National Drug Code (NDC) system is used to identify specific drug products. NDC 65862-0672 is assigned to a specific manufacturer/labeler and dosage form/strength. Changes in manufacturing or labeling may require a new NDC.
• Drug Shortage Monitoring: While not currently a significant issue for nateglinide, the FDA monitors for potential drug shortages. Disruptions in API supply or manufacturing issues for any generic version could lead to temporary shortages.

The regulatory pathway for generic nateglinide is well-established. Future regulatory actions are likely to focus on maintaining manufacturing quality and addressing any emerging safety signals. No major regulatory changes are anticipated that would fundamentally alter the market dynamics for nateglinide itself, beyond the standard oversight applied to all pharmaceuticals.

Key Takeaways

Nateglinide (NDC 65862-0672) is a mature generic antidiabetic drug with a stable but declining market share. Intense competition among generic manufacturers has resulted in aggressive pricing, with net prices significantly reduced by PBM rebates. The market outlook is for continued price erosion and a gradual decrease in prescription volume due to the emergence of newer antidiabetic classes offering superior efficacy and broader outcome benefits. Regulatory oversight remains standard for generic pharmaceuticals, focusing on cGMP compliance and post-market surveillance.

Frequently Asked Questions

1. What is the primary therapeutic class of nateglinide? Nateglinide belongs to the meglitinide class of oral antidiabetic drugs.
2. Are there any new clinical trials ongoing for nateglinide that could impact its market status? Given its mature status and the prevalence of newer agents, large-scale clinical trials for nateglinide are unlikely. Research is more focused on novel antidiabetic mechanisms.
3. What is the typical duration of treatment with nateglinide? Treatment duration is determined by individual patient response and glycemic control, managed by a healthcare provider.
4. How does nateglinide compare in terms of efficacy to metformin? Nateglinide primarily targets postprandial glucose by stimulating rapid insulin release, while metformin's primary action is to reduce hepatic glucose production and improve insulin sensitivity. Efficacy is patient-dependent and often depends on the combination of therapies used.
5. Can nateglinide be used in combination with other diabetes medications? Yes, nateglinide is often used in combination with other oral antidiabetic agents, such as metformin, to achieve better glycemic control.

Citations

[1] U.S. Food and Drug Administration. (1999). FDA Approves Starlix (nateglinide) Tablets. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-starlix-nateglinide-tablets

[2] American Diabetes Association. (2023). Standards of Medical Care in Diabetes—2023. Diabetes Care, 46(Supplement_1). doi:10.2337/dc23-s001