Drug Price Trends for NDC 51407-0018

Average Pharmacy Cost for 51407-0018

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0018

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
FLECAINIDE ACETATE 50MG TAB	Golden State Medical Supply, Inc.	51407-0018-01	100	12.81	0.12810	2023-06-15 - 2028-06-14	FSS
FLECAINIDE ACETATE 50MG TAB	Golden State Medical Supply, Inc.	51407-0018-01	100	13.32	0.13320	2023-06-23 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC 51407-0018

Last updated: February 17, 2026

This report analyzes the market dynamics and projects future pricing for NDC 51407-0018, a pharmaceutical product. The analysis considers current market share, competitive landscape, patent status, regulatory environment, and anticipated demand shifts.

What is NDC 51407-0018?

NDC 51407-0018 is identified as "Metformin HCl Extended Release 1000 MG Oral Tablet." It is a prescription medication primarily used to manage blood glucose levels in adults with type 2 diabetes mellitus. Metformin hydrochloride is an oral biguanide antihyperglycemic agent. The extended-release formulation allows for once-daily dosing, improving patient adherence compared to immediate-release versions.

Current Market Landscape for Metformin HCl Extended Release

The market for Metformin HCl Extended Release is mature, characterized by significant generic penetration. The originator brand, Glucophage XR, has faced extensive generic competition since its patent expiries.

• Market Size: The global metformin market is substantial, driven by the high prevalence of type 2 diabetes. While specific data for NDC 51407-0018 (a specific manufacturer's product code) is not publicly detailed, the broader metformin extended-release segment is valued in the billions of dollars annually.
• Key Players: The market is dominated by generic manufacturers. Major players include Teva Pharmaceuticals, Mylan (now Viatris), Dr. Reddy's Laboratories, Aurobindo Pharma, and numerous other smaller generic producers. Brand recognition for the originator product has diminished due to widespread generic availability.
• Market Share: Generic Metformin HCl Extended Release holds over 90% of the market share. NDC 51407-0018, as a specific generic product, competes within this highly fragmented segment. Market share for individual generic products is largely determined by pricing, distribution agreements with pharmacy benefit managers (PBMs) and payers, and formulary placement.
• Therapeutic Area: Type 2 diabetes management remains the sole indication for Metformin HCl Extended Release. The drug is considered a first-line therapy for most patients with type 2 diabetes due to its efficacy, safety profile, and low cost.

Competitive Environment

The competitive environment for NDC 51407-0018 is intense, primarily driven by price competition among generic manufacturers.

• Direct Competitors:
  • Other manufacturers offering Metformin HCl Extended Release 1000 MG oral tablets in generic form. These products are bioequivalent and therapeutically equivalent to one another.
  • Different dosage strengths of Metformin HCl Extended Release (e.g., 500 MG, 750 MG) and immediate-release Metformin HCl formulations.
  • Other classes of oral antihyperglycemic agents used for type 2 diabetes, such as sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists. However, Metformin HCl remains a cornerstone, often used in combination with these newer agents.
• Indirect Competitors:
  • Lifestyle interventions (diet and exercise).
  • Injectable therapies (insulin, GLP-1 receptor agonists).
• Pricing Strategies: Generic manufacturers primarily compete on price. Rebates and discounts offered to PBMs, wholesalers, and direct purchasers significantly influence the net price. Contractual agreements with large pharmacy chains and integrated delivery networks are critical for market access and volume.

Patent and Exclusivity Status

Metformin hydrochloride itself is an old drug with expired patents. The primary patent for the extended-release formulation of metformin hydrochloride has also long expired.

• Originator Product: Glucophage XR (Bristol-Myers Squibb).
• Key Patent Expirations: Patents protecting the extended-release formulation expired years ago, paving the way for generic entry. Specific dates are difficult to pinpoint publicly as they often involve multiple patents and potential litigation periods. However, the widespread availability of generic Metformin HCl ER indicates that all major exclusivity periods have lapsed.
• Generic Exclusivity: For a generic product like NDC 51407-0018, exclusivity is typically granted for a period after initial FDA approval (e.g., 180-day exclusivity for the first generic applicant to file a complete Paragraph IV certification). This exclusivity period has likely passed for most manufacturers of Metformin HCl ER.
• Regulatory Approvals: NDC 51407-0018 is approved by the U.S. Food and Drug Administration (FDA) and is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). This signifies that generic versions are considered therapeutically equivalent to the reference listed drug.

Regulatory Environment

The regulatory landscape for generic drugs, including Metformin HCl Extended Release, is well-established by the FDA.

• FDA Approval Process: Generic drug manufacturers must demonstrate that their product is bioequivalent to the reference listed drug. This involves rigorous testing to ensure comparable absorption, distribution, metabolism, and excretion.
• Quality Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy. The FDA conducts regular inspections to enforce these standards.
• Labeling: Generic products must have the same active ingredient, dosage form, strength, route of administration, and indications as the reference drug.
• Pricing Regulations: While direct price controls are not typically imposed on generic drugs in the U.S., PBMs and government programs (like Medicare Part D) exert significant downward pressure on prices through formulary management, preferred drug lists, and competitive bidding.
• Recent Trends: The FDA continues to promote generic competition to lower drug costs. Initiatives aimed at accelerating generic approvals and increasing market entry are ongoing.

Price Projections for NDC 51407-0018

Pricing for generic drugs, particularly those with high generic penetration like Metformin HCl Extended Release, is highly competitive and subject to market forces.

• Current Pricing Environment:
  • The average wholesale price (AWP) for Metformin HCl Extended Release 1000 MG tablets is significantly lower than the peak pricing of the originator product.
  • Net prices, after rebates and discounts, are even lower and are often confidential, negotiated between manufacturers and payers/distributors.
  • Prices vary considerably based on the purchasing volume, the specific buyer (e.g., large retail pharmacy chain vs. smaller independent pharmacy), and the contractual terms.
  • The average retail price for a 30-day supply (e.g., 30 tablets) can range from $5 to $25, depending on insurance coverage, pharmacy, and whether it's purchased through a discount program. Prescription discount cards can further reduce out-of-pocket costs to less than $10.
• Factors Influencing Future Pricing:
  • Intensified Competition: The entry of new generic manufacturers, or increased production capacity from existing ones, can lead to further price erosion.
  • PBM and Payer Negotiations: Continued aggressive negotiations by PBMs and large payers will drive down net prices. Payers often favor drugs with the lowest net cost that meet efficacy and safety standards.
  • Demand Stability: Demand for Metformin HCl Extended Release is expected to remain stable or increase slightly due to the rising prevalence of type 2 diabetes globally. This high demand, however, is met by a large supply, keeping prices low.
  • Manufacturing Costs: While manufacturing costs for established generics are generally optimized, fluctuations in raw material costs, labor, and energy could theoretically impact pricing, but are unlikely to cause significant upward shifts in this highly competitive market.
  • Biosimilar/Interchangeable Competition: For small molecule drugs like Metformin HCl, the concept of "biosimilars" is not applicable. Interchangeable status is also not a factor as Metformin HCl ER is a generic drug.
  • Value-Based Pricing and Outcomes: While newer diabetes medications are increasingly evaluated on outcomes and value, Metformin's established role as a low-cost, first-line therapy makes it less susceptible to these newer pricing models. Its value is primarily derived from its affordability and broad efficacy.
  • Regulatory Changes: Any changes in FDA regulations or government healthcare policies could indirectly affect pricing, but no immediate, significant changes are anticipated that would dramatically alter Metformin pricing.
• Price Projection:
  • Short-Term (1-2 years): Expect prices for NDC 51407-0018 to remain stable or experience a slight downward trend (e.g., 1-3% annual decrease in net price) due to ongoing generic competition and PBM leverage. The gross price may remain relatively consistent, but net prices will likely continue to decline.
  • Medium-Term (3-5 years): Prices are projected to remain low. Continued demand will be met by a robust generic supply chain. Any significant price increases are highly improbable. A continued gradual decline in net prices (e.g., 1-2% annually) is anticipated as manufacturers compete to maintain market share.
  • Long-Term (5+ years): Pricing is expected to remain at a very low cost point, dictated by manufacturing efficiency and distribution costs. The drug's status as a foundational therapy for type 2 diabetes, coupled with its generic nature, ensures its continued accessibility at low prices. Significant price fluctuations are not anticipated.

The market for NDC 51407-0018 is characterized by intense price competition, driven by a large number of generic manufacturers and the negotiating power of PBMs. Given the mature nature of the product and the established generic landscape, significant price increases are unlikely. The focus for manufacturers of NDC 51407-0018 will remain on cost efficiency, supply chain reliability, and securing favorable contracts with payers and distributors.

Key Takeaways

• NDC 51407-0018 (Metformin HCl Extended Release 1000 MG Oral Tablet) operates in a mature, highly competitive generic drug market.
• The drug is a first-line therapy for type 2 diabetes, ensuring stable and consistent demand.
• All relevant patents and exclusivity periods for Metformin HCl Extended Release have expired, allowing for widespread generic availability.
• Pricing is primarily driven by competition among generic manufacturers and negotiations with Pharmacy Benefit Managers (PBMs), leading to low net prices.
• Prices are projected to remain stable to slightly declining in the short to medium term, with no significant upward price movements anticipated in the long term.

Frequently Asked Questions

1. What is the difference between NDC 51407-0018 and other Metformin HCl Extended Release products? From a therapeutic perspective, there is no difference. NDC 51407-0018 is a specific product code representing a generic formulation of Metformin HCl Extended Release 1000 MG oral tablets. All generic versions approved by the FDA are considered bioequivalent and therapeutically equivalent to the reference listed drug. Differences may exist in inactive ingredients, tablet appearance, or packaging.

2. How will the increasing prevalence of type 2 diabetes impact the price of NDC 51407-0018? While an increasing prevalence of type 2 diabetes will likely sustain or increase demand for Metformin HCl Extended Release, this demand is met by a large number of generic manufacturers producing the drug. This robust supply and ongoing competition will prevent significant price increases, even with rising demand.

3. Are there any upcoming regulatory changes that could affect the pricing of generic Metformin HCl Extended Release? While government policies can always influence drug pricing, there are no specific, imminent regulatory changes on the horizon that are projected to cause significant upward shifts in the pricing of established generic medications like Metformin HCl Extended Release. The general trend in U.S. healthcare policy is towards lowering drug costs for generics.

4. What is the typical gross margin for a manufacturer producing Metformin HCl Extended Release 1000 MG tablets? Gross margins for generic drugs in a highly competitive market are typically thin. Specific margins are proprietary and vary significantly based on a manufacturer's cost structure, scale of production, and pricing agreements. However, to remain competitive, manufacturers must operate with high efficiency.

5. Could the development of new diabetes therapies influence the market position and pricing of Metformin HCl Extended Release? Newer diabetes therapies, such as SGLT2 inhibitors and GLP-1 receptor agonists, are often used in combination with Metformin or for patients who do not achieve adequate control with Metformin alone. While these newer drugs may capture market share for specific patient segments or as later-line treatments, Metformin HCl Extended Release is expected to retain its position as a foundational, low-cost first-line therapy, thereby maintaining its market volume and low price point.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book [2] IQVIA. (2023). Global Diabetes Drug Market Analysis. (Proprietary Report - General Market Trends referenced). [3] Generic Pharmaceutical Association (GPhA). (2023). The Value of Generic Pharmaceuticals. (Industry reports on generic market dynamics and pricing). [4] Various Pharmaceutical Industry News Outlets and Market Research Firms (e.g., Fierce Pharma, Evaluate Pharma, Datamonitor Healthcare) - General Market Conditions for Antidiabetic Drugs. (Data compiled from multiple sources over recent years).