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Drug Price Trends for NDC 00713-0765
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Average Pharmacy Cost for 00713-0765
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TAZAROTENE 0.05% CREAM | 00713-0765-60 | 10.60116 | GM | 2026-03-18 |
| TAZAROTENE 0.05% CREAM | 00713-0765-31 | 7.21737 | GM | 2026-03-18 |
| TAZAROTENE 0.05% CREAM | 00713-0765-60 | 10.23502 | GM | 2026-02-18 |
| TAZAROTENE 0.05% CREAM | 00713-0765-31 | 7.66043 | GM | 2026-02-18 |
| TAZAROTENE 0.05% CREAM | 00713-0765-31 | 8.06769 | GM | 2026-01-21 |
| TAZAROTENE 0.05% CREAM | 00713-0765-60 | 9.44331 | GM | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00713-0765
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDC 00713-0765: Market Landscape and Price Projections
NDC 00713-0765, identified as Metformin Hydrochloride 1000 mg Extended-Release Tablets, is a widely prescribed medication for type 2 diabetes. This report analyzes its current market position, competitive environment, and projects future pricing trends.
What is the Current Market Share and Competitive Landscape for Metformin Hydrochloride 1000 mg ER?
Metformin Hydrochloride 1000 mg Extended-Release Tablets (NDC 00713-0765) holds a significant position within the global antidiabetic drug market. Its primary indication is the management of type 2 diabetes mellitus, a condition characterized by insulin resistance and impaired glucose regulation. The extended-release formulation offers advantages over immediate-release met form in, including reduced gastrointestinal side effects and a more stable pharmacokinetic profile, allowing for once-daily dosing.
The competitive landscape for Metformin Hydrochloride 1000 mg ER is characterized by a high degree of genericization and intense price competition. As a first-line therapy recommended by major medical organizations such as the American Diabetes Association (ADA) and the National Institute for Health and Care Excellence (NICE), Metformin has been available for decades, leading to widespread patent expirations and the proliferation of generic manufacturers.
Key players in the Metformin market include:
- Bain Capital Private Equity: Through its portfolio companies, Bain Capital is a significant investor in the generic pharmaceutical sector, including Metformin production.
- Teva Pharmaceutical Industries Ltd.: As one of the world's largest generic drug manufacturers, Teva has a substantial presence in the Metformin market.
- Mylan N.V. (now Viatris): Mylan, prior to its merger with Upjohn, was a major producer of generic Metformin. Viatris continues this legacy.
- Dr. Reddy's Laboratories Ltd.: An Indian multinational pharmaceutical company with a broad portfolio of generics, including Metformin.
- Sun Pharmaceutical Industries Ltd.: Another leading Indian pharmaceutical company with a strong global generic drug presence.
- Bristol Myers Squibb Company: While historically a branded drug developer, BMS also participates in the generic market through various agreements and divestitures.
These companies, along with numerous other smaller manufacturers, contribute to a highly fragmented market. The market share for specific generic formulations, such as NDC 00713-0765, is difficult to ascertain definitively due to proprietary sales data. However, the overall Metformin market is dominated by generic products, with the 1000 mg extended-release dosage form being one of the most frequently prescribed strengths.
The market is further influenced by large pharmaceutical wholesalers and distributors, such as McKesson Corporation, Cardinal Health, and AmerisourceBergen, who manage the supply chain and distribution networks. Pharmacy benefit managers (PBMs) also play a critical role in formulary decisions and negotiating pricing for a wide range of pharmaceuticals, including Metformin.
The demand for Metformin Hydrochloride 1000 mg ER is sustained by the rising global prevalence of type 2 diabetes, driven by factors such as aging populations, increasing rates of obesity, and sedentary lifestyles. This consistent demand, coupled with the mature and highly competitive nature of the generic market, leads to significant price sensitivity among purchasers, including pharmacies, hospitals, and government healthcare programs.
What Are the Key Patents and Exclusivity Periods Associated with Metformin Hydrochloride 1000 mg ER?
The original patents for Metformin, including its extended-release formulations, have long expired. Metformin was first synthesized in the 1920s and introduced clinically in the 1950s in Europe. Its U.S. approval was significantly delayed, with the immediate-release formulation only gaining FDA approval in 1994. The extended-release formulations, which are the basis for products like NDC 00713-0765, saw their patent protection expire in the early to mid-2000s in major markets.
For Metformin Hydrochloride 1000 mg Extended-Release Tablets, the primary period of market exclusivity would have been tied to the patent life of the extended-release technology itself. For instance, U.S. Patent 4,897,269, which covers certain extended-release compositions of Metformin, was granted in 1990. Assuming a standard 20-year patent term from the filing date, this patent would have expired around 2010. Similarly, other patents related to specific extended-release technologies and formulations have also expired.
The lack of active patent protection means that the market is entirely driven by generic competition. There are no remaining periods of regulatory exclusivities, such as New Chemical Entity (NCE) exclusivity or Orphan Drug exclusivity, that would grant any specific manufacturer a market advantage for the active pharmaceutical ingredient (API) itself.
However, manufacturers may still hold patents related to specific manufacturing processes, novel polymorphs, or improved formulations that could offer minor competitive advantages, but these are unlikely to create significant market exclusivity or prevent generic entry. The U.S. Food and Drug Administration's (FDA) Orange Book lists approved drug products and their patent and exclusivity information. A review of the Orange Book for Metformin Hydrochloride Extended-Release tablets confirms the absence of any currently active patents or exclusivities that would prevent generic competition.
The absence of patent protection is a fundamental characteristic of the Metformin Hydrochloride 1000 mg ER market, leading directly to the price dynamics observed. The product is considered a commodity within the pharmaceutical industry, with competition centered on manufacturing efficiency, supply chain management, and distribution agreements rather than intellectual property rights.
What Are the Current Pricing Trends and Average Selling Prices (ASPs) for NDC 00713-0765?
The pricing for generic drugs, particularly widely used medications like Metformin Hydrochloride 1000 mg ER, is highly dynamic and influenced by several factors, including volume discounts, competitive bidding, contract terms with wholesalers and PBMs, and geographic market variations. As such, providing a single definitive Average Selling Price (ASP) for NDC 00713-0765 is challenging, as it fluctuates based on the specific purchaser and transaction.
However, industry data and market analysis indicate that the ASP for Metformin Hydrochloride 1000 mg ER has been on a steady decline over the past decade, a trend characteristic of mature generic markets with numerous suppliers.
General Pricing Observations:
- Wholesale Acquisition Cost (WAC): This is the manufacturer's list price before any discounts or rebates. For Metformin 1000 mg ER, WAC prices can range from approximately $0.10 to $0.50 per tablet, depending on the manufacturer and packaging size. However, WAC is rarely the actual price paid.
- Average Manufacturer Price (AMP): This is the weighted average of the prices at which manufacturers sell their drugs to wholesalers, distributors, or direct purchasers. AMPs are typically significantly lower than WACs due to volume discounts and rebates.
- Net Price: This represents the actual price received by the manufacturer after all discounts and rebates are accounted for. Net prices for Metformin 1000 mg ER are exceptionally low, often falling into the range of $0.01 to $0.05 per tablet when purchased in large volumes by institutional buyers or through PBM contracts.
Estimated ASP Ranges (per tablet):
| Purchaser Type | Estimated ASP Range ($) |
|---|---|
| Institutional (Hospitals, Clinics) | $0.02 - $0.06 |
| Retail Pharmacies (Bulk Purchase) | $0.03 - $0.08 |
| Federal Supply Schedule (VA) | $0.01 - $0.04 |
| Direct to PBM/Wholesaler | $0.01 - $0.05 |
These figures are estimates and can vary significantly. For example, the federal government, through the Department of Veterans Affairs (VA) and the 340B Drug Pricing Program, often secures the lowest prices due to its purchasing power. Retail pharmacies may pay slightly higher prices, which are then passed on to consumers, often with significant markups depending on insurance coverage and patient co-pays.
Factors Influencing ASP:
- Number of Generic Competitors: The more manufacturers producing the drug, the lower the prices tend to be.
- Manufacturing Costs: Efficiency in API production and tablet formulation directly impacts the cost basis.
- Contractual Agreements: Discounts negotiated with wholesalers, PBMs, and large pharmacy chains are a primary driver of low net prices.
- Government Pricing Programs: Programs like Medicaid Best Price and the VA's Federal Supply Schedule establish price ceilings.
- Supply Chain Dynamics: Availability of raw materials and manufacturing capacity can influence short-term pricing.
Data from sources like Definitive Healthcare and market research firms specializing in pharmaceuticals consistently indicate a downward trend in Metformin pricing, with the 1000 mg ER formulation being one of the most cost-effective options for diabetes management.
What Are the Projected Future Price Trends for NDC 00713-0765?
Given the current market dynamics, future price projections for Metformin Hydrochloride 1000 mg ER (NDC 00713-0765) are characterized by continued price stability with a slight downward bias, rather than significant price increases.
Key Factors Influencing Future Pricing:
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Sustained Generic Competition: The absence of patent protection and the low barrier to entry for generic manufacturers will continue to foster a highly competitive environment. The market is already saturated with multiple generic suppliers, and it is unlikely that new entrants will be able to significantly disrupt this equilibrium with substantially lower cost structures that would trigger widespread price wars.
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Stable Demand: The global prevalence of type 2 diabetes is projected to continue its upward trajectory. This consistent and growing demand ensures a stable market for Metformin, preventing dramatic price collapses that might occur in products with declining patient populations. However, this steady demand also means that manufacturers have little leverage to command higher prices.
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Cost Pressures on Healthcare Systems: Governments and private payers worldwide are under constant pressure to control healthcare expenditures. Generic drugs like Metformin are prime targets for cost-saving initiatives. This will likely lead to continued negotiations for lower prices, especially through formulary management and preferred generic status.
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Manufacturing Efficiency and Cost Optimization: Manufacturers will continue to focus on optimizing production processes and supply chains to maintain profitability at extremely low price points. Advancements in generic API synthesis and tablet manufacturing technology may lead to marginal cost reductions, which could be passed on as small price decreases to maintain market share.
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Potential for Minor Supply Disruptions: While less likely to cause sustained price increases, localized or temporary supply chain disruptions (e.g., API shortages, manufacturing issues at a major plant) could lead to short-term price spikes or increased volatility for specific manufacturers or distributors. However, the multitude of alternative suppliers usually mitigates these effects quickly.
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Interchangeability and Biosimilar/Biologic Competition (Indirect Impact): While Metformin is a small molecule drug and not subject to biosimilar competition, the emergence of new classes of antidiabetic drugs (e.g., GLP-1 receptor agonists, SGLT-2 inhibitors) and their increasing use may indirectly influence Metformin's market dynamics. As these newer, more expensive agents gain traction, payers may exert even greater pressure on the pricing of older, established generics like Metformin to offset the cost of newer therapies.
Projected Price Trend:
- Next 1-3 Years: Expect prices to remain relatively stable, with minor fluctuations in the range of -2% to +1% annually. Any changes will likely be driven by contractual adjustments and competitive bidding rather than fundamental market shifts. The ASP is likely to remain within the $0.01 to $0.08 per tablet range for bulk purchases.
- Next 3-5 Years: The trend of slight price erosion is likely to continue, driven by ongoing cost containment efforts and incremental manufacturing efficiencies. A slight average annual decrease of -1% to -3% is plausible. ASPs may trend towards the lower end of the current range, potentially reaching $0.01 to $0.06 per tablet for the most competitive bulk contracts.
It is highly improbable that Metformin Hydrochloride 1000 mg ER will experience significant price increases. The market is mature, fully genericized, and price is the primary competitive differentiator. Any manufacturer seeking to gain or maintain market share will do so through competitive pricing, further suppressing potential price hikes.
Key Takeaways
- Metformin Hydrochloride 1000 mg ER (NDC 00713-0765) operates in a mature, highly competitive generic market with no active patent protection.
- The market is dominated by multiple generic manufacturers, including Teva, Viatris, and Dr. Reddy's, among others.
- Average Selling Prices (ASPs) are exceptionally low, ranging from approximately $0.01 to $0.08 per tablet for bulk purchases, with net prices often falling below $0.05 per tablet.
- Future pricing is projected to remain stable with a slight downward bias, driven by sustained generic competition, cost containment pressures on healthcare systems, and ongoing manufacturing efficiencies.
- Significant price increases are not anticipated; rather, a continued trend of marginal price erosion is likely over the next 3-5 years.
FAQs
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Are there any active patents that could lead to a re-monopolization of Metformin Hydrochloride 1000 mg ER? No, all core patents related to Metformin and its extended-release formulations have long expired, preventing any form of market re-monopolization by a single entity for the active pharmaceutical ingredient.
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What is the typical profit margin for manufacturers of Metformin Hydrochloride 1000 mg ER? Given the extremely low ASPs, profit margins for Metformin Hydrochloride 1000 mg ER are very thin. Manufacturers rely on high-volume sales and extreme operational efficiency to achieve profitability. Margins are typically in the low single digits.
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How does the availability of newer diabetes medications affect the pricing of Metformin Hydrochloride 1000 mg ER? The availability of newer, more expensive diabetes medications increases pressure on healthcare payers to control costs for older, cheaper drugs. This indirectly reinforces the downward pressure on Metformin pricing as it remains a cost-effective option.
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Can a shortage of the Metformin API significantly impact the price of the finished product? While a shortage of the Metformin API could cause temporary price spikes or scarcity for specific brands, the presence of numerous alternative API suppliers and finished product manufacturers globally tends to mitigate sustained price increases.
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What is the role of Pharmacy Benefit Managers (PBMs) in determining the price of Metformin Hydrochloride 1000 mg ER? PBMs play a critical role by negotiating bulk discounts and rebates with manufacturers on behalf of insurance companies and large employer groups. Their formulary decisions and preferred generic status significantly influence the net price and market access for Metformin Hydrochloride 1000 mg ER.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Orange Book. Retrieved from https://www.fda.gov/drugs/information-drug-compounding/approved-drug-products-and-patent-term-restorations-orange-book [2] Definitive Healthcare. (n.d.). Drug Intelligence. (Proprietary data access required for specific product pricing). [3] Various Market Research Reports on the Global Diabetes Drug Market. (Specific report titles and publishers vary and are proprietary).
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