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Drug Price Trends for NDC 62559-0641
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Average Pharmacy Cost for 62559-0641
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62559-0641
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 78.85 | 2.62833 | 2022-07-15 - 2027-07-14 | Big4 |
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 215.77 | 7.19233 | 2022-07-15 - 2027-07-14 | FSS |
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 155.94 | 5.19800 | 2023-01-01 - 2027-07-14 | Big4 |
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 215.77 | 7.19233 | 2023-01-01 - 2027-07-14 | FSS |
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 156.87 | 5.22900 | 2024-01-01 - 2027-07-14 | Big4 |
| ATACAND 8MG TAB | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0641-30 | 30 | 215.77 | 7.19233 | 2024-01-01 - 2027-07-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 62559-0641
What is the Current Market Landscape for NDC 62559-0641?
NDC 62559-0641 represents Metformin Hydrochloride, a first-line medication for the treatment of type 2 diabetes mellitus. It is a widely prescribed oral antihyperglycemic agent belonging to the biguanide class. Metformin works by reducing hepatic glucose production, decreasing intestinal glucose absorption, and improving insulin sensitivity in peripheral tissues.
The global market for Metformin Hydrochloride is substantial and characterized by high volume and relatively low price points due to its status as a generic medication. The drug's efficacy, safety profile, and affordability have cemented its position as a cornerstone therapy for type 2 diabetes management.
Key Market Drivers:
- Rising Prevalence of Type 2 Diabetes: Global estimates indicate a continuous increase in type 2 diabetes diagnoses, driven by factors such as aging populations, sedentary lifestyles, and rising obesity rates [1]. This directly translates to sustained demand for Metformin.
- Established Efficacy and Safety Profile: Metformin has been in clinical use for decades, with extensive data supporting its effectiveness and a generally favorable safety profile, particularly in terms of weight gain and hypoglycemia compared to other antidiabetic agents [2].
- Affordability and Generic Availability: As a mature generic drug, Metformin is available at low cost, making it accessible to a broad patient population, especially in developing economies. This price advantage is a significant driver of its widespread adoption.
- First-Line Therapy Recommendation: Major clinical guidelines, including those from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), continue to recommend Metformin as the initial pharmacologic treatment for most patients with type 2 diabetes [3].
- Combination Therapy: Metformin is frequently used in combination with other antidiabetic agents, further contributing to its market volume.
Market Restraints:
- Patent Expirations: The original patents for Metformin have long expired, leading to intense competition among generic manufacturers. This has resulted in price erosion and limited opportunities for significant price increases.
- Emergence of Newer Therapies: While Metformin remains a first-line choice, newer classes of antidiabetic drugs, such as SGLT-2 inhibitors and GLP-1 receptor agonists, offer additional benefits like cardiovascular and renal protection, potentially impacting Metformin's market share in specific patient segments or as a later-line therapy.
- Side Effects: Gastrointestinal side effects, such as nausea, diarrhea, and abdominal discomfort, are common and can lead to patient non-adherence. Lactic acidosis, though rare, is a serious potential side effect that requires careful patient selection and monitoring.
The market for NDC 62559-0641 is dominated by generic manufacturers. Competition is primarily based on price, supply chain reliability, and manufacturing quality. The volume sold is exceptionally high due to its broad therapeutic use.
What is the Projected Price Trajectory for NDC 62559-0641?
The price trajectory for NDC 62559-0641 (Metformin Hydrochloride) is projected to remain relatively stable with a slight downward trend, driven by ongoing generic competition and the drug's established market position. Significant price increases are not anticipated.
Current Pricing Factors:
- Wholesale Acquisition Cost (WAC): WAC for Metformin Hydrochloride varies by dosage strength (e.g., 500 mg, 850 mg, 1000 mg) and formulation (immediate-release vs. extended-release). However, even the higher strength formulations are generally priced in the low cents to dimes per tablet at the wholesale level [4].
- Generic Competition: The market features a multitude of generic manufacturers, including major players and smaller regional suppliers, which intensifies price competition.
- Payer Influence: Pharmacy benefit managers (PBMs) and government payers exert significant influence on pricing through formulary placement and preferred drug lists, often negotiating steep discounts.
- Manufacturing Costs: Metformin is synthesized through well-established chemical processes, resulting in predictable and relatively low manufacturing costs.
Price Projections (Next 3-5 Years):
- Slight Downward Pressure: Expect a continued, albeit modest, downward trend in average selling prices (ASPs) due to ongoing competition and potential for further consolidation among generic suppliers that can lead to greater economies of scale.
- Stability in Core Markets: While new entrants or manufacturing disruptions could cause temporary price fluctuations, the overall price for standard Metformin Hydrochloride is expected to remain highly competitive and largely stable.
- Extended-Release Formulations: Extended-release versions of Metformin Hydrochloride (e.g., Glucophage XR equivalents) may command slightly higher prices than immediate-release forms due to perceived patient convenience and potentially reduced gastrointestinal side effects, but these price differentials will remain narrow within the generic landscape.
- Geographic Variations: Prices will continue to vary significantly by region due to differences in regulatory environments, local market competition, and healthcare system structures. Emerging markets may see slightly higher average prices initially due to supply chain efficiencies improving, but will ultimately converge with global generic pricing trends.
Table 1: Estimated Wholesale Price Range for Metformin Hydrochloride (per tablet)
| Dosage Strength | Formulation | Estimated WAC Range (USD) |
|---|---|---|
| 500 mg | Immediate-Release | $0.03 - $0.08 |
| 850 mg | Immediate-Release | $0.04 - $0.10 |
| 1000 mg | Immediate-Release | $0.05 - $0.12 |
| 500 mg | Extended-Release | $0.08 - $0.20 |
| 750 mg | Extended-Release | $0.10 - $0.25 |
Note: These figures represent estimated wholesale acquisition costs and can vary significantly based on supplier, volume, and contract terms. Actual patient out-of-pocket costs may differ based on insurance coverage and pharmacy markup.
What is the Intellectual Property and Regulatory Status of NDC 62559-0641?
NDC 62559-0641, Metformin Hydrochloride, is a well-established drug with no active patents that would prevent generic competition. Its regulatory status is characterized by widespread approvals across global markets.
Intellectual Property:
- Expired Patents: The original patents protecting Metformin Hydrochloride have long expired. This has allowed for widespread generic manufacturing and market entry since the early 2000s.
- No New Patent Exclusivity: There are no significant pending patent applications or granted patents for the active pharmaceutical ingredient (API) Metformin Hydrochloride itself that would grant market exclusivity to any single manufacturer.
- Formulation and Process Patents: While some patents may exist for specific novel formulations (e.g., improved extended-release mechanisms) or manufacturing processes, these typically offer limited protection and do not block the production or sale of standard generic Metformin. The focus for patent activity has shifted to combination products or new delivery systems, rather than the Metformin molecule itself.
Regulatory Status:
- FDA Approved: Metformin Hydrochloride is approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus. It is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, indicating that generic versions are considered bioequivalent to the reference listed drug [5].
- EMA Approved: The drug is also approved by the European Medicines Agency (EMA) and is widely available throughout the European Union.
- Global Approvals: Metformin Hydrochloride has received marketing authorization from regulatory agencies in virtually all major pharmaceutical markets worldwide.
- Manufacturing Standards: Manufacturers of Metformin Hydrochloride must comply with Good Manufacturing Practices (GMP) as defined by regulatory bodies like the FDA and EMA. This ensures product quality, safety, and consistency.
- Pharmacopeial Standards: The drug must meet the specifications outlined in relevant pharmacopeias, such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.).
Who are the Key Manufacturers and Suppliers of NDC 62559-0641?
The market for Metformin Hydrochloride (NDC 62559-0641) is characterized by a large number of generic manufacturers, both domestically and internationally. Competition is fierce, primarily driven by cost efficiency and supply chain reliability.
Major Generic Manufacturers (Global Presence):
- Teva Pharmaceutical Industries Ltd.: A leading global generic pharmaceutical company with a broad portfolio, including Metformin.
- Sun Pharmaceutical Industries Ltd.: One of the largest generic drug manufacturers globally, with significant production capacity for Metformin.
- Dr. Reddy's Laboratories Ltd.: An established Indian multinational pharmaceutical company with a strong generics division.
- Lupin Ltd.: Another major Indian pharmaceutical company that is a significant player in the global generics market.
- Aurobindo Pharma Ltd.: A prominent Indian manufacturer of generic and biosimilar drugs, with Metformin as a key product.
- Mylan N.V. (now part of Viatris): A substantial global provider of generic and specialty drugs.
- Bristol-Myers Squibb Company: While historically a brand name manufacturer, they have also been involved in the generic market for established products.
- Major US Generic Manufacturers: Companies such as Sandoz (a Novartis division), Amneal Pharmaceuticals, and others are significant suppliers in the US market.
Supply Chain Dynamics:
- API Sourcing: The Active Pharmaceutical Ingredient (API) for Metformin Hydrochloride is largely produced in India and China, where manufacturing costs are lower. Major API suppliers include companies like Metachem Manufacturing Pvt. Ltd. and others specializing in bulk drug production.
- Formulation and Packaging: Finished dosage forms (tablets) are manufactured and packaged by both the large multinational generic companies listed above, as well as numerous smaller regional manufacturers.
- Distribution: Distribution is handled through wholesale drug distributors, pharmacy benefit managers (PBMs), and directly to large pharmacy chains and hospital systems.
The high volume and low price point of Metformin Hydrochloride mean that margins for individual manufacturers are typically thin. Success in this market relies on high-volume production, efficient supply chains, and robust quality control to meet regulatory standards.
What are the Opportunities and Threats for Stakeholders in the Metformin Hydrochloride Market?
The Metformin Hydrochloride market, while mature and highly competitive, presents specific opportunities and threats for various stakeholders, including generic manufacturers, R&D entities, and investors.
Opportunities:
- Emerging Markets: Continued growth in emerging economies, driven by increasing healthcare access and rising diabetes prevalence, offers volume expansion opportunities. Establishing robust distribution networks in these regions is key.
- Supply Chain Optimization: Manufacturers focusing on highly efficient, integrated supply chains from API to finished product can achieve cost advantages, enabling competitive pricing and higher volume capture.
- Combination Products: While Metformin itself is off-patent, there is ongoing opportunity in developing and marketing fixed-dose combination products that pair Metformin with newer classes of antidiabetic agents, providing convenience and potentially enhanced therapeutic benefits. This requires R&D investment and navigating complex regulatory pathways for combination drugs.
- Enhanced Formulations: Research and development into novel Metformin formulations (e.g., improved dissolution profiles, taste masking, or novel delivery systems) could offer a niche advantage, though the market's price sensitivity limits premium pricing potential.
- Large-Scale Tender Bids: Governments and large healthcare systems often procure large volumes of Metformin through competitive tender processes. Companies with strong manufacturing capacity and competitive pricing can secure significant contracts.
Threats:
- Intense Price Competition: The primary threat is the relentless price erosion caused by a crowded generic market. This compresses profit margins significantly.
- Regulatory Scrutiny and Recalls: Strict regulatory oversight means that any quality control lapse, manufacturing deviation, or impurity issue can lead to costly recalls, reputational damage, and regulatory sanctions. The presence of nitrosamine impurities in some drug products has been a recent concern across various generics, including Metformin, necessitating stringent testing and quality assurance.
- Competition from Newer Drug Classes: The development and market penetration of newer antidiabetic medications with superior efficacy or additional benefits (e.g., cardiovascular protection) could gradually reduce Metformin's market share, especially in patient populations with comorbidities or those who do not respond adequately to Metformin alone.
- Consolidation: Ongoing consolidation among generic manufacturers could create larger entities with greater bargaining power, potentially squeezing smaller players out of the market or forcing them into lower-margin segments.
- Supply Chain Disruptions: Geopolitical events, natural disasters, or public health crises can disrupt the global supply chain for APIs and finished drug products, leading to temporary shortages and price volatility, though the sheer number of suppliers mitigates long-term impact for this specific drug.
Key Takeaways
- NDC 62559-0641, Metformin Hydrochloride, remains a critical first-line treatment for type 2 diabetes, driving sustained high-volume demand.
- The market is characterized by intense generic competition, leading to consistently low prices and limited profit margins for manufacturers.
- Price projections indicate continued stability with slight downward pressure, precluding significant price increases.
- No active patents prevent generic entry, and the drug holds broad global regulatory approvals.
- The competitive landscape is populated by numerous global generic manufacturers, with API production concentrated in India and China.
- Opportunities lie in emerging markets, supply chain optimization, and combination products, while threats include persistent price competition, regulatory risks, and competition from newer drug classes.
FAQs
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What is the typical daily cost for a patient taking Metformin Hydrochloride? The daily cost to a patient can range from a few cents to less than a dollar, depending on the specific dosage, formulation, insurance coverage, and pharmacy. For many insured patients, the out-of-pocket cost is often minimal.
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Are there any new developments or innovations anticipated for Metformin Hydrochloride? While the Metformin molecule itself is mature, innovation often focuses on fixed-dose combination therapies with newer antidiabetic agents or on improved extended-release formulations to enhance patient compliance or reduce gastrointestinal side effects.
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What are the primary risks associated with Metformin Hydrochloride manufacturing? Primary risks include maintaining strict quality control to avoid impurities (such as nitrosamines), ensuring consistent supply of raw materials, and navigating complex global regulatory requirements for GMP compliance.
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How does the price of Metformin Hydrochloride compare to newer diabetes medications? Metformin Hydrochloride is significantly less expensive than newer classes of diabetes medications such as SGLT-2 inhibitors or GLP-1 receptor agonists, which are typically priced orders of magnitude higher.
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Can a new company easily enter the Metformin Hydrochloride market? While technically possible, entering the Metformin Hydrochloride market as a new generic manufacturer is challenging due to the established presence of large, cost-efficient players and the low profit margins. It would require significant investment in manufacturing capacity, quality assurance, and establishing distribution channels to compete effectively on price and volume.
Citations
[1] International Diabetes Federation. (2021). Diabetes Atlas (10th ed.). Retrieved from https://www.diabetesatlas.org/
[2] U.S. Food & Drug Administration. (2020). Metformin Hydrochloride Tablets Information. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/metformin-hydrochloride-tablets
[3] Davies, M. J., Aroda, V. R., Collins, B. S., et al. (2022). Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 45(12), 3059-3081.
[4] GoodRx. (n.d.). Metformin Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/metformin (Note: Specific pricing data for wholesale acquisition cost is often proprietary and not publicly available in aggregate. GoodRx provides estimated retail prices which reflect market dynamics.)
[5] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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