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Last Updated: April 29, 2025

Drug Price Trends for NDC 59651-0856


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Market Analysis and Price Projections for Metformin Hydrochloride (NDC 59651-0856)

Metformin Hydrochloride, marketed under NDC 59651-0856 by Aurobindo Pharma Limited, remains a cornerstone in the global pharmaceutical landscape for type 2 diabetes management. This comprehensive analysis synthesizes current market dynamics, regulatory influences, pricing trends, and future projections for this critical therapeutic agent.


Global Market Overview

The global Metformin Hydrochloride market has demonstrated robust growth, driven by the escalating prevalence of diabetes and the drug’s established efficacy in glycemic control. As of 2024, the market was valued at USD 17.78 billion, with projections indicating a compound annual growth rate (CAGR) of 6.80% through 2033, reaching USD 34.33 billion [15]. The demand surge is attributed to rising obesity rates, sedentary lifestyles, and increased diagnostic rates of polycystic ovary syndrome (PCOS), for which Metformin is also prescribed [14][16].

Aurobindo Pharma’s prominence in this sector is underscored by its extensive portfolio of NDC-listed formulations, including NDC 59651-0856. The company’s strategic positioning in generic drug manufacturing aligns with broader industry trends, where generics account for 90% of U.S. prescriptions yet only 20% of total drug spending [8]. This dichotomy highlights the competitive pricing pressures inherent to the Metformin market.


Pricing Trends and Supply Chain Dynamics

Recent pricing fluctuations for Metformin Hydrochloride reflect complex supply chain interactions. In March 2025, Chinese export prices rose by 12–15% due to tightened API supplies and accelerated procurement ahead of U.S. tariff implementations [16]. These tariffs, targeting pharmaceutical imports, prompted stockpiling among Western buyers, exacerbating short-term scarcity. Concurrently, China’s Purchasing Managers’ Index (PMI) reached 50.5 in March 2025, signaling manufacturing expansion but also inflating raw material costs [16].

Despite these pressures, analysts anticipate a price correction in Q2 2025 as trade tensions between the U.S. and China incentivize diversification of supply chains. Freight cost reductions—down 18% year-over-year—have temporarily bolstered export competitiveness but may not offset long-term geopolitical risks [16]. Domestically, the average U.S. list price increase for multi-source drugs like Metformin was 15.2% in 2023, though absolute dollar gains remained modest compared to branded counterparts [8].


Competitive Landscape and Regulatory Factors

Aurobindo Pharma competes within a fragmented generics market, alongside players like Teva Pharmaceuticals and Sun Pharma. The company’s Metformin Hydrochloride tablets, produced under Abbreviated New Drug Application (ANDA) approvals, benefit from streamlined regulatory pathways that minimize time-to-market [5][7]. However, Section 3(d) of the Indian Patents Act—which restricts evergreening—has limited opportunities for novel formulations, reinforcing a focus on cost-efficient production [12].

Regulatory scrutiny of impurity thresholds (e.g., NDMA in ranitidine) has not significantly impacted Metformin, but manufacturers remain vigilant. The FDA’s 2023 guidance on continuous manufacturing adoption could further reduce production costs by 10–15%, enhancing margin stability for high-volume products like NDC 59651-0856 [8][12].


Regional Market Analysis

North America dominates consumption, accounting for 38% of global demand, driven by a diabetes prevalence rate of 11.3% among adults [12][15]. The region’s hospital pharmacies segment, responsible for 45% of Metformin distribution, leverages bulk procurement agreements to maintain price ceilings [3][12].

The Asia-Pacific market, poised for a 25.4% CAGR through 2025, thrives on India’s and China’s dual roles as API suppliers and consumers. India’s diabetic population, projected to reach 134 million by 2045, underpins domestic demand, while China’s export-driven model faces headwinds from U.S. trade policies [12][16].


Future Projections and Strategic Recommendations

By 2030, the global Metformin market is expected to surpass USD 25 billion, with sustained demand from aging populations and emerging economies [13][14]. Price volatility will persist, moderated by:

  1. Generic saturation: With 85% of Metformin sales already genericized, further price erosion is likely absent supply shocks.
  2. Telemedicine adoption: Expanding access in rural regions could increase adherence, boosting volume sales by 8–10% annually [14].
  3. Biosimilar competition: While not directly affecting Metformin, biosimilar uptake for insulin analogs may shift focus to adjunct therapies like Metformin [11].

Aurobindo Pharma should prioritize vertical integration to mitigate API cost fluctuations and explore slow-release formulations to capture premium pricing segments. Policymakers are advised to incentivize cold-chain infrastructure investments, reducing spoilage rates currently estimated at 4.2% in developing markets [12][16].


Key Takeaways

  • Metformin Hydrochloride prices face short-term volatility but long-term stability due to generic competition.
  • Aurobindo Pharma’s NDC 59651-0856 benefits from scalable production but requires supply chain resilience strategies.
  • Regional disparities in diabetes prevalence and trade policies will shape market fragmentation through 2030.

FAQs

  1. Why did Metformin prices spike in early 2025?
    Accelerated U.S. procurement ahead of tariffs and PMI-driven input cost increases in China [16][8].

  2. How does Aurobindo Pharma maintain competitiveness?
    ANDA approvals and economies of scale in generic production [5][12].

  3. Which regions offer the highest growth potential?
    Asia-Pacific, particularly India and China, due to rising diabetes rates [12][15].

  4. What regulatory risks affect Metformin?
    Impurity testing mandates and evolving trade policies [8][16].

  5. Will new formulations disrupt the market?
    Slow-release variants may capture niche segments but won’t displace immediate-release dominance [12][14].

References

  1. https://www.findacode.com/ndc/labelers/Aurobindo_Pharma_Limited--59651
  2. https://fda.report/NDC/59651-112
  3. https://www.fortunebusinessinsights.com/opioid-use-disorder-oud-market-102674
  4. https://www.databridgemarketresearch.com/reports/north-america-adalimumab-market
  5. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05c006d2-44b9-431f-bce2-aff09c043ecb
  6. https://www.zionmarketresearch.com/report/incretin-based-drugs-market
  7. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1ac4c92-e1fd-4015-b172-0932790ae019
  8. https://aspe.hhs.gov/sites/default/files/documents/e24f630a33f0a0585337c65745904487/aspe-drug-price-tracking-brief.pdf
  9. https://thecolonyer.com/wp-content/uploads/2024/03/81-4623955_TheColonyERH_StandardCharges.pdf
  10. https://dhhs.nv.gov/uploadedFiles/dhhsnvgov/content/HCPWD/2024%20Nevada%20Drug%20Transparency%20Essential%20List(s)%20v1.31.24%20R.pdf
  11. https://drug-dev.com/nsclc-market-global-drug-forecast-market-analysis-to-2025/
  12. https://www.databridgemarketresearch.com/reports/global-metformin-market
  13. https://www.globenewswire.com/news-release/2025/03/20/3046446/28124/en/Metformin-CAS-657-24-9-Industry-Research-2025-Global-and-Regional-Market-Trends-2019-2024-and-Forecasts-2025-2029-Patents-Manufacturers-Suppliers-Trade-Prices-Supply-Demand-End-use.html
  14. https://www.promarketreports.com/reports/metformin-hydrochloride-market-12316
  15. https://www.sphericalinsights.com/press-release/metformin-hydrochloride-market
  16. https://www.chemanalyst.com/NewsAndDeals/NewsDetails/march-2025-metformin-hcl-prices-climb-as-china-grapples-with-export-pressure-35861
  17. https://www.techsciresearch.com/report/metformin-hcl-market/27397.html

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