Last updated: August 2, 2025
Overview of NDC 00185-0325
NDC 00185-0325 refers specifically to a pharmaceutical product manufactured by Teva Pharmaceuticals. As of the latest available data, it is identified as Glyburide and Metformin hydrochloride tablets, 500 mg/500 mg. This combination medication is primarily prescribed for managing type 2 diabetes mellitus, offering a dual-action approach by enhancing insulin sensitivity (Metformin) and stimulating insulin secretion (Glyburide).
Market Landscape
Epidemiological Context
Type 2 diabetes remains a significant global health concern, with an increasing patient population. The International Diabetes Federation estimates over 463 million adults living with diabetes worldwide in 2019, projected to reach 700 million by 2045[1]. The U.S. has an adult prevalence rate of approximately 10.5%, translating into an estimated 34 million Americans with diabetes, with even more managing prediabetes[2].
This growth sustains a steady demand for affordable, effective oral hypoglycemics like Glyburide/Metformin. The brand-name formulations are increasingly challenged by generic equivalents, which dominate the market due to cost advantages.
Competitive Landscape
Market competition includes several generics and biosimilars:
- Brand Names: Diabeta (Glyburide), Glucophage (Metformin)
- Generic Combinations: Multiple manufacturers, including Mylan, Teva, Sandoz, and others, offer generic Glyburide and Metformin tablets.
- Biosimilars and Alternatives: While biosimilars are more relevant for injectable drugs, oral combinations face a crowded generic market.
Regulatory and Patent Considerations
Teva's NDC 00185-0325 is a generic version of the branded combination. Patent expirations for key formulations and recent patent challenges influence market availability. Teva’s role as a well-established generic producer grants advantageous distribution channels, though regulatory approvals in various jurisdictions shape market access.
Pricing Analysis
Historical Pricing Trends
Pricing for generic Glyburide/Metformin formulations has historically declined, driven by market saturation and increased competition. According to IQVIA data:
- Wholesale Acquisition Cost (WAC): Avg. $30–$50 for a 30-day supply (30 tablets of 500 mg/500 mg)[3].
- Average Reimbursement Rates: Medicare Part D, Medicaid, and private insurers reimburse in the range of $20–$40, depending on negotiated discounts.
- Patient Out-of-Pocket (OOP): Often $10–$30, influenced by insurance coverage.
Current Market Pricing
As of 2023, the price for Teva's Glyburide/Metformin 500 mg/500 mg tablets has stabilized around:
- Wholesale Price: ~$0.50–$1.00 per tablet.
- Retail Price: Approximately $15–$25 per month for the generic, competitive with other generics.
Specialty pharmacies may offer lower prices based on discount programs and patient assistance schemes.
Pricing Trends and Driver Factors
- Generic Competition: Entry of multiple generic manufacturers suppresses prices.
- Rebate and Discount Programs: Insurers and PBMs secure significant discounts, impacting net prices.
- Regulatory Changes: Patent litigations and ANDA approvals influence market entry and pricing dynamics.
- Manufacturing Costs: Economies of scale in generics further depress retail prices.
Market Dynamics and Price Projection
Near-Term Outlook (1–2 Years)
Given the highly competitive nature of the generic glyburide/metformin market:
- Price Stability or Slight Decline: Prices are unlikely to decrease significantly. Competition maintains downward pressure, but existing low margins limit further reductions.
- Increased Biosimilar/Generic Entry: Marginal, barring regulatory delays or patent litigations. Entry of new competitors may momentarily push prices lower.
- Impact of Supply Chain Variability: Recent disruptions may cause short-term price fluctuations but are unlikely to alter the long-term trend.
Mid to Long-Term Outlook (3–5 Years)
- Market Saturation: As the space becomes fully saturated with generics, prices are expected to stabilize.
- Potential for Price Increases: Bundling of additional therapeutic options or formulation innovations (e.g., fixed-dose combinations with extended-release) could create upward pricing pressure.
- Payer Negotiations: Insurers' push for cost-effective generics will maintain low retail prices but could drive manufacturers to optimize margins through volume, not price increases.
Impact of New Therapeutics
- The introduction of newer anti-diabetes agents (e.g., SGLT2 inhibitors, GLP-1 receptor agonists) with demonstrated cardiovascular benefits could influence the market. However, for cost-sensitive population segments, generic Glyburide/Metformin remains an essential therapy, stabilizing demand and pricing in the short to medium term.
Strategic Implications for Stakeholders
- Manufacturers: Focus on cost-efficient manufacturing and supply chain resilience to maintain margins.
- Insurers and PBMs: Continue to leverage rebates and formulary management to promote generic uptake and control costs.
- Healthcare Providers: Emphasize personalized treatment, balancing newer therapies’ benefits with cost considerations.
- Patients: Benefit from low-cost generics but require ongoing education for optimal adherence.
Conclusion
The market for NDC 00185-0325 (Glyburide and Metformin) remains robust due to its essential role in managing type 2 diabetes, especially among cost-sensitive populations. Presently, prices are low and expected to remain stable or trend downward slightly in the próximao future, constrained by intense generic competition. While innovative diabetes therapies are emerging, the affordability and proven efficacy of this combination keep it relevant.
Pricing projections suggest a steady state with marginal fluctuations driven by market saturation, regulatory developments, and payer strategies. Stakeholders should monitor patent statuses and clinical guidelines to anticipate shifts affecting market dynamics.
Key Takeaways
- Market Stability: The Glyburide/Metformin market is mature with consistent demand and aggressive generic competition, keeping prices low.
- Pricing Trajectory: Prices are expected to stabilize or decline marginally over 2–5 years, barring major regulatory or market disruptions.
- Competitive Advantages: Manufacturers who optimize supply chain and reduce costs will sustain profitability amid price pressures.
- Strategic Focus: Stakeholders should prioritize cost management, regulatory navigation, and formulary positioning to retain market share.
- Patient Impact: Consumers benefit from affordable generic options, though ongoing education on effective use remains critical.
FAQs
Q1: How does patent expiration affect the price of NDC 00185-0325?
A: Patent expirations typically trigger increased generic competition, leading to significant price reductions as multiple manufacturers enter the market.
Q2: Are there biosimilar options for Glyburide and Metformin?
A: No. Biosimilars are generally applicable to injectable biologics. Oral drug combinations like Glyburide/Metformin rely on generics rather than biosimilars.
Q3: What factors could drive an increase in the price of this medication?
A: Introduction of specialty formulations, shortages, supply chain disruptions, or regulatory barriers could temporarily raise prices.
Q4: How does insurance coverage influence patient costs for NDC 00185-0325?
A: Rebate agreements and formulary placements lower out-of-pocket expenses, often making the medication highly affordable for insured patients.
Q5: What role do healthcare policies play in shaping the market?
A: Policies encouraging generic utilization and cost containment directly influence pricing strategies and market competitiveness.
References
- International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
- CDC. National Diabetes Statistics Report, 2020.
- IQVIA. National Prescription Audit, 2023.
