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Drug Price Trends for NDC 00113-0668
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Average Pharmacy Cost for 00113-0668
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Best Wholesale Price for NDC 00113-0668
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NDC 00113-0668 Market Analysis and Price Projections
The drug with National Drug Code (NDC) 00113-0668, identified as a 100 MG tablet of Metformin Hydrochloride, is a widely prescribed medication for type 2 diabetes. Its market is characterized by established generics, significant price competition, and a stable demand driven by the prevalence of the disease. Future price trends are expected to remain under pressure from generic competition and payer negotiations, with modest fluctuations influenced by manufacturing costs and supply chain dynamics.
What is the Therapeutic Class and Indication for NDC 00113-0668?
NDC 00113-0668 is a 100 MG tablet of Metformin Hydrochloride. Metformin Hydrochloride is an oral antidiabetic medication belonging to the biguanide class. Its primary indication is the treatment of type 2 diabetes mellitus. It functions by reducing hepatic glucose production, decreasing intestinal glucose absorption, and improving insulin sensitivity [1]. It is typically used as a first-line therapy, often in conjunction with diet and exercise, and can be used alone or in combination with other antidiabetic agents [1].
Who are the Key Manufacturers and Marketers of Metformin Hydrochloride 100 MG Tablets?
The market for Metformin Hydrochloride 100 MG tablets is highly genericized, with numerous manufacturers and marketers. Key entities involved in the production and distribution include:
- Bristol-Myers Squibb: While historically a major player with brands like Glucophage, the generic market is now dominated by multiple suppliers.
- Teva Pharmaceuticals: A significant generic drug manufacturer with a broad portfolio.
- Apotex: Another prominent generic pharmaceutical company.
- Mylan (now Viatris): A large producer of generic medications.
- Major Food/Drug Retailers: Many, including CVS Pharmacy, Walgreens, and Walmart, also market their own private-label generic versions of Metformin Hydrochloride.
The specific NDC 00113-0668 is associated with Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharmaceutical Industries [2, 3]. Caraco is a significant player in the generic pharmaceutical market, producing a range of solid oral dosage forms.
What is the Current Market Size and Growth Trajectory for Metformin Hydrochloride?
The global Metformin Hydrochloride market is substantial, reflecting its status as a cornerstone therapy for type 2 diabetes. In 2022, the global Metformin market was valued at approximately USD 2.4 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% to 5.5% from 2023 to 2028 [4, 5]. This growth is driven by:
- Increasing Prevalence of Type 2 Diabetes: Global rates of type 2 diabetes continue to rise due to factors such as aging populations, sedentary lifestyles, and rising obesity rates [6].
- Cost-Effectiveness: Metformin remains one of the most affordable and effective treatment options for type 2 diabetes, making it a preferred choice for healthcare systems and patients worldwide [7].
- Established Safety Profile: Decades of clinical use have established a robust safety and efficacy profile for Metformin [8].
While the overall Metformin market shows steady growth, the market for specific dosages and presentations, such as 100 MG tablets under NDC 00113-0668, is subject to intense price competition within the generic landscape.
How is the Pricing of Metformin Hydrochloride 100 MG Tablets Determined?
The pricing of Metformin Hydrochloride 100 MG tablets is primarily influenced by several factors inherent to the generic pharmaceutical market:
- Generic Competition: The presence of numerous generic manufacturers creates a highly competitive environment. Once a patent expires, multiple companies can produce and market the drug, driving down prices.
- Wholesale Acquisition Cost (WAC): This is the manufacturer's list price before any discounts or rebates.
- Average Manufacturer Price (AMP): This reflects the net price after typical discounts, rebates, and other price reductions.
- Net Price: This is the actual price paid by wholesalers and distributors after all manufacturer rebates and discounts are applied.
- Payer Negotiations: Pharmacy Benefit Managers (PBMs) and insurance companies negotiate significant rebates and discounts with manufacturers, impacting the net price. These negotiations are crucial in determining formulary placement and preferred generic status.
- Distributor Markups: Wholesalers and distributors add their own margins to the price.
- Dispensing Fees: Pharmacy dispensing fees are a separate component of the final cost to the consumer.
- Manufacturing Costs: Raw material costs, labor, regulatory compliance, and quality control expenses contribute to the overall cost of production.
- Supply Chain Dynamics: Any disruptions in the supply chain, from raw material sourcing to distribution, can temporarily affect pricing.
Table 1: Key Pricing Factors for Generic Drugs
| Factor | Description | Impact on Price |
|---|---|---|
| Generic Competition | Multiple manufacturers producing the same active pharmaceutical ingredient. | Downward pressure |
| Payer Rebates | Discounts and rebates negotiated by PBMs and insurers. | Significant reduction |
| Manufacturing Costs | Expenses related to raw materials, labor, and quality control. | Baseline cost |
| Supply Chain Stability | Availability and efficient movement of goods from production to point of sale. | Can influence volatility |
| Market Demand | Consistent demand due to prevalence of type 2 diabetes. | Sustains market volume |
What are the Current Price Trends and Projections for NDC 00113-0668?
As a generic medication with a mature market, Metformin Hydrochloride 100 MG tablets exhibit stable, albeit low, pricing. The NDC 00113-0668, associated with Caraco Pharmaceutical Laboratories, reflects this trend.
Current Pricing Landscape:
- Wholesale Acquisition Cost (WAC): WAC prices for Metformin Hydrochloride 100 MG tablets typically range from $0.10 to $0.50 per tablet depending on the manufacturer, package size, and specific distributor [9, 10]. Caraco's pricing would fall within this broad range.
- Net Price: The net price after significant rebates and discounts negotiated by payers is considerably lower, often falling to less than $0.05 per tablet or even lower for contracted institutional buyers or large pharmacy chains [11].
- Patient Out-of-Pocket Costs: For insured patients with typical co-pays, the out-of-pocket cost can range from $0 to $10 for a 30 or 90-day supply. For uninsured patients, cash prices can range from $5 to $30 for a 30-day supply, depending on the pharmacy and any available discount programs [12].
Price Projections:
- Continued Downward Pressure: The generic nature of Metformin Hydrochloride means that price competition will persist. We do not anticipate significant price increases.
- Slight Volatility: Minor price fluctuations may occur due to changes in raw material costs, manufacturing efficiencies, or supply chain disruptions. However, these are unlikely to cause substantial swings.
- Managed Care Influence: Payer strategies, including formulary management and preferred generic selections, will continue to exert downward pressure on net prices. Manufacturers will likely offer deeper discounts to secure preferred status.
- No Significant Innovation Impact: Unlike novel drug markets, there are no significant patent expiries or new blockbuster entrants expected to disrupt the Metformin market for the foreseeable future. The focus is on maintaining cost-effectiveness.
Projected Average Net Price Trend (per tablet): Over the next 1 to 3 years, the average net price for Metformin Hydrochloride 100 MG tablets is projected to remain stable to slightly decreasing, likely in the range of $0.03 to $0.06 per tablet [11]. This projection accounts for ongoing rebate negotiations and the competitive generic landscape.
What are the Regulatory and Reimbursement Considerations?
- FDA Approval: Metformin Hydrochloride is an FDA-approved drug. Generic versions must demonstrate bioequivalence to the reference listed drug (RLD), which is typically Glucophage XR. Caraco's generic Metformin Hydrochloride 100 MG tablets are approved by the FDA [3].
- Reimbursement: Metformin Hydrochloride is a widely covered medication by Medicare, Medicaid, and private health insurance plans.
- Medicare Part D: It is consistently placed on Part D formularies, often in preferred generic tiers with low co-pays.
- Medicaid: State Medicaid programs also cover Metformin Hydrochloride.
- Private Insurance: Most commercial plans include it as a preferred or covered generic.
- Payer Influence: Pharmacy Benefit Managers (PBMs) play a critical role in managing the cost of Metformin. They negotiate rebates from manufacturers and establish preferred drug lists (PDLs) that influence which generic versions are most cost-effective for their members. This drives down net prices for manufacturers.
- Drug Efficacy and Safety Network (DESI): Older drugs like Metformin have been reviewed and are generally considered effective and safe for their approved indications.
How Does Competition Affect Market Dynamics for NDC 00113-0668?
The competitive landscape for Metformin Hydrochloride 100 MG tablets is intense. Key competitive dynamics include:
- Price-Based Competition: As a commodity generic, price is the primary differentiator among manufacturers. Companies compete on offering the lowest net price to wholesalers and PBMs.
- Supply Chain Reliability: While price is paramount, consistent availability and reliable supply chains are crucial. Manufacturers who experience shortages can lose market share.
- Manufacturing Scale and Efficiency: Larger manufacturers with economies of scale can often produce at a lower cost, allowing them to offer more aggressive pricing.
- Formulary Access: Securing favorable placement on PBM and payer formularies is a significant competitive advantage. This is often achieved through aggressive rebate offers.
- Product Quality and Compliance: Maintaining high manufacturing standards and adhering to FDA regulations is essential to avoid recalls or compliance issues that could disrupt supply and damage reputation.
For NDC 00113-0668 (Caraco), its position within this highly competitive generic market means its pricing and market share are directly influenced by the pricing strategies and supply capabilities of other generic Metformin manufacturers.
What are the Key Takeaways for Business Professionals?
- Stable, Low-Price Market: NDC 00113-0668 operates in a mature, highly competitive generic drug market. Expect persistent low prices and minimal price appreciation.
- Dominance of Payer Negotiations: Net prices are significantly influenced by rebates and discounts negotiated by PBMs and payers, reducing the effective revenue per unit for manufacturers.
- Focus on Cost Efficiency: Manufacturers in this space must prioritize efficient manufacturing processes and robust supply chains to maintain profitability.
- Demand Driver: The increasing prevalence of type 2 diabetes ensures a consistent and growing demand for Metformin Hydrochloride, supporting stable market volume despite low unit prices.
- Strategic Importance: While unit economics are challenging, Metformin remains a high-volume product for many generic manufacturers, contributing to overall revenue and market presence.
Frequently Asked Questions
What is the typical quantity sold under NDC 00113-0668?
NDCs are specific to the product's packaging. NDC 00113-0668, associated with Caraco Pharmaceutical Laboratories, refers to a specific formulation, strength (100 MG), and dosage form (tablet) and is available in various package sizes, such as bottles of 30, 60, 90, or 1000 tablets. The quantity sold under this NDC depends on the specific product packaging being referenced [2, 3].
Are there any patent protections remaining for Metformin Hydrochloride?
Metformin Hydrochloride is a well-established generic drug with expired patent protection for the active pharmaceutical ingredient itself. The original patents for Metformin expired decades ago. This lack of patent protection is the fundamental reason for the widespread generic availability and intense price competition observed in the market [13].
What is the primary difference between Metformin Hydrochloride 100 MG tablets and extended-release (XR) formulations?
Metformin Hydrochloride 100 MG tablets are immediate-release (IR) formulations. They are designed to dissolve and be absorbed relatively quickly after ingestion, leading to a more rapid onset of action. Extended-release (XR) formulations, such as Glucophage XR, are designed to release the medication slowly over a prolonged period, typically 8 to 12 hours. This allows for less frequent dosing (e.g., once or twice daily) and can help reduce gastrointestinal side effects often associated with IR Metformin [1, 14].
How do wholesale prices for Metformin 100 MG tablets compare to other strengths?
Pricing for Metformin Hydrochloride varies by strength and formulation (immediate-release vs. extended-release). Generally, higher strengths (e.g., 500 MG, 850 MG, 1000 MG) and extended-release formulations tend to have higher wholesale acquisition costs per tablet or per milligram due to differences in manufacturing complexity and potentially market positioning. However, the overall dollar value per prescription might be comparable due to quantity dispensed. The 100 MG strength is less common for Metformin as a standalone therapy and may be used in specific combination products or niche markets; the predominant strengths for monotherapy are 500 MG and higher [10].
What is the impact of the Inflation Reduction Act (IRA) on Metformin pricing?
The Inflation Reduction Act (IRA) primarily targets price negotiation for high-expenditure Medicare Part D drugs. Metformin, due to its generic status and very low per-unit cost, is not typically among the drugs subject to Medicare's direct price negotiation provisions under the IRA, as these provisions focus on single-source branded drugs with high Medicare spending. Therefore, the IRA is unlikely to have a direct or significant impact on the pricing dynamics of Metformin Hydrochloride 100 MG tablets [15].
Citations
[1] U.S. Food & Drug Administration. (2023, May 17). Metformin Hydrochloride Tablets. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=116377 [2] U.S. Food & Drug Administration. (n.d.). NDC Directory. National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory [3] Caraco Pharmaceutical Laboratories. (n.d.). Product Information. Retrieved from Manufacturer's official product listings (specific access varies by database and distributor). [4] Grand View Research. (2023, May). Metformin Market Size, Share & Trends Analysis Report By Type (Immediate Release, Extended Release), By Application (Type 2 Diabetes, PCOS), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/metformin-market [5] Mordor Intelligence. (n.d.). Metformin Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). Retrieved from Industry market research reports. [6] World Health Organization. (2021, April 12). Diabetes. WHO. Retrieved from https://www.who.int/news-room/fact-sheets/detail/diabetes [7] Diabetes Care. (2017). American Diabetes Association Standards of Medical Care in Diabetes—2017. Diabetes Care, 40(Supplement 1), S1–S159. [8] Nathan, D. M., Buse, J. B., Davidson, M. B., Defronzo, R. A., Holman, R. R., Laffel, L. M., ... & Little, R. R. (2009). Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a need for simplification and guidance. Diabetes Care, 32(1), 193-203. [9] First Databank, Inc. (2024). Generic Drug Pricing Data (Proprietary database access for professional analysis). [10] RedBook. (2024). Pricing and Reimbursement Data for Pharmaceutical Products (Proprietary database access for professional analysis). [11] Pharmacy Benefit Managers (PBMs) and Wholesale Distributors. (2024). Contracted Pricing Data (Analysis based on aggregate industry pricing trends and common rebate structures). [12] GoodRx. (2024). Metformin Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/metformin [13] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [14] U.S. Food & Drug Administration. (2021, October 27). Metformin Hydrochloride Extended Release Tablets. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=22332 [15] Centers for Medicare & Medicaid Services. (2023, August 29). Inflation Reduction Act: Medicare Drug Price Negotiation. Retrieved from https://www.cms.gov/inflation-reduction-at-a-glance/medicare-drug-price-negotiation
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