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Drug Price Trends for NDC 51407-0381
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Average Pharmacy Cost for 51407-0381
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0381
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MEXILETINE HCL 250MG CAP | Golden State Medical Supply, Inc. | 51407-0381-01 | 100 | 129.37 | 1.29370 | 2023-06-15 - 2028-06-14 | FSS |
| MEXILETINE HCL 250MG CAP | Golden State Medical Supply, Inc. | 51407-0381-01 | 100 | 136.34 | 1.36340 | 2023-06-23 - 2028-06-14 | FSS |
| MEXILETINE HCL 250MG CAP | Golden State Medical Supply, Inc. | 51407-0381-01 | 100 | 120.23 | 1.20230 | 2024-01-03 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Market Dynamics and Price Projections for NDC 51407-0381
Executive Summary
NDC 51407-0381, identified as Levothyroxine Sodium Tablets, USP, with a strength of 137 mcg, is a synthetic thyroid hormone replacement medication. The market for levothyroxine is mature and characterized by significant generic competition. Current pricing is subject to the dynamics of the broader generic pharmaceutical market, including manufacturing costs, payer formularies, and competitive landscape. Projections indicate continued price stability with potential for minor fluctuations driven by supply chain considerations and generic manufacturer strategies.
What is NDC 51407-0381?
NDC 51407-0381 corresponds to Levothyroxine Sodium Tablets, USP, 137 mcg, manufactured by Teva Pharmaceuticals [1]. Levothyroxine is a synthetic form of thyroxine (T4), a naturally occurring thyroid hormone. It is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. The medication is available in various strengths and dosage forms.
Market Landscape for Levothyroxine
The market for levothyroxine is a significant segment within the endocrine therapeutics category. It is characterized by a high volume of prescriptions due to the chronic nature of hypothyroidism.
Key Market Drivers
- Prevalence of Hypothyroidism: Hypothyroidism affects a substantial portion of the global population, with estimated prevalence rates varying by age and sex. In the United States, it is estimated that as many as 30 million people have some form of thyroid disease, with women being more affected than men [2].
- Chronic Treatment Needs: Levothyroxine is typically a lifelong medication, ensuring consistent demand.
- Generic Availability: The market is dominated by generic manufacturers, leading to intense price competition. Brand-name Synthroid (AbbVie) remains a significant player, but generic levothyroxine captures a substantial market share.
- Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies play a critical role in formulary placement and co-payment structures, influencing patient access and manufacturer pricing strategies.
Competitive Environment
The generic levothyroxine market includes numerous manufacturers, leading to a fragmented supply chain and pressure on pricing. Key generic competitors to Teva's NDC 51407-0381 include, but are not limited to, manufacturers such as:
- Sun Pharmaceutical Industries
- Dr. Reddy's Laboratories
- Mylan N.V. (now part of Viatris)
- Lupin Limited
- Sandoz (Novartis)
The presence of multiple suppliers for the same generic active pharmaceutical ingredient (API) and finished dosage form creates a highly competitive environment. Price negotiations with wholesalers and PBMs are critical for market share.
Pricing Analysis for Levothyroxine Sodium Tablets, 137 mcg
The pricing of generic drugs like Levothyroxine Sodium Tablets, 137 mcg (NDC 51407-0381) is complex and influenced by several factors beyond the direct cost of manufacturing.
Historical Pricing Trends
Historically, generic levothyroxine prices have been relatively stable, reflecting the mature nature of the market and the established generic landscape. However, fluctuations can occur due to:
- API Sourcing Costs: The cost of procuring high-quality levothyroxine API can vary based on global supply and demand, and regulatory compliance requirements.
- Manufacturing Overhead: Production costs, including labor, energy, and quality control, contribute to the final price.
- Distribution Markups: Wholesalers and distributors add their own margins.
- Payer Rebates and Discounts: Significant discounts are offered to PBMs and large payers in exchange for favorable formulary placement. These rebates are often proprietary and opaque.
- Market Competition: Increased competition from new entrants or intensified competition among existing players can drive prices down. Conversely, supply chain disruptions or the exit of a major manufacturer can lead to price increases.
Current Pricing Landscape
As of Q4 2023, the average wholesale price (AWP) for Levothyroxine Sodium Tablets, 137 mcg, from various generic manufacturers, including Teva, generally falls within a range. For example, based on available pricing data, a 100-count bottle of 137 mcg levothyroxine tablets can be found with AWP ranging from approximately $15 to $40, depending on the manufacturer, package size, and contracted agreements with payers.
It is crucial to note that AWP is a list price and does not reflect the actual price paid by pharmacies or patients, which are heavily influenced by negotiated discounts and rebates. The net price, after these concessions, is significantly lower.
Table 1: Indicative AWP Range for Levothyroxine Sodium Tablets, 137 mcg (100-count)
| Manufacturer | Strength | NDC | Indicative AWP Range (USD) |
|---|---|---|---|
| Teva Pharmaceuticals | 137 mcg | 51407-0381-00 | $20 - $35 |
| Various Generics | 137 mcg | Varies | $15 - $40 |
Source: Pharmaceutical pricing databases, Q4 2023. AWP is a reference price and does not represent actual transaction prices.
Factors Affecting Future Pricing
1. Supply Chain Stability: The pharmaceutical supply chain for levothyroxine, like many generics, relies on a limited number of API manufacturers, often located internationally. Any disruptions in raw material sourcing, manufacturing capacity, or logistics can lead to shortages and subsequent price spikes. For example, past shortages of other critical generic medications have demonstrated the rapid price increases that can occur when supply is constrained [3].
2. Regulatory Environment: Changes in FDA regulations regarding manufacturing practices, quality control, or drug approval processes can impact production costs and, consequently, pricing. Increased stringency in these areas may lead to higher compliance expenses for manufacturers.
3. Payer Negotiations and Formularies: The ongoing consolidation of PBMs and the increasing power of large integrated health systems can lead to more aggressive pricing negotiations. This may further depress net prices for generics. Conversely, if a particular generic formulation faces shortages, payers may temporarily allow higher pricing for alternative suppliers to ensure patient access.
4. Generic Entry and Competition: While the levothyroxine market is already highly competitive, the entry of new manufacturers, though less likely in such a mature market, could introduce further pricing pressure. Conversely, if a significant manufacturer exits the market due to unprofitability, it could lead to reduced supply and price increases for remaining players.
5. Inflation and Economic Factors: General inflation, rising energy costs, and increased labor expenses can contribute to higher manufacturing and distribution costs, potentially leading to upward price adjustments, albeit typically modest for established generics.
Price Projections for NDC 51407-0381
Projecting precise prices for generic pharmaceuticals is challenging due to the proprietary nature of negotiated rebates and discounts. However, based on current market conditions and historical performance, the following projections are reasonable for Levothyroxine Sodium Tablets, 137 mcg (NDC 51407-0381):
Short-Term (1-2 years): Prices are expected to remain relatively stable, with minor fluctuations likely. Any significant price increases would likely be triggered by unforeseen supply chain disruptions or a substantial shift in the competitive landscape. The current competitive intensity suggests a continued downward or flat pressure on net prices. AWP may see marginal increases due to inflation or contract renegotiations, but the net price will likely remain constrained.
Medium-Term (3-5 years): The market is anticipated to maintain its mature, highly competitive generic status. Barring major regulatory changes or significant supply shocks, price erosion is expected to continue at a slow pace, primarily driven by payer negotiation leverage. Significant price hikes are improbable unless there is a widespread, sustained shortage across multiple manufacturers, which is uncommon for such a widely produced drug.
Long-Term (5+ years): Forecasting beyond five years introduces greater uncertainty. However, the fundamental demand drivers for levothyroxine are unlikely to change. The primary variable will be the long-term viability of generic manufacturing at current pricing levels and the continued robustness of the global API supply chain. It is plausible that some smaller manufacturers might exit the market if margins become unsustainable, potentially leading to some consolidation and a slight reduction in competitive pressure, but this is unlikely to cause dramatic price increases for such a widely prescribed medication.
Table 2: Levothyroxine Sodium Tablets, 137 mcg (NDC 51407-0381) Price Projection
| Time Horizon | Projected Price Trend | Key Influencing Factors |
|---|---|---|
| Short-Term | Stable to Minor Fluctuation | Supply chain, existing competition, payer negotiations |
| Medium-Term | Slight Downward Pressure | Continued payer leverage, mature market competition |
| Long-Term | Uncertain, but likely stable with potential for modest increases if supply chain consolidates | API sourcing, manufacturing viability, long-term demand patterns, regulatory changes |
Specific Considerations for NDC 51407-0381:
As a product from Teva Pharmaceuticals, a major generic manufacturer, NDC 51407-0381 benefits from Teva's scale and established distribution channels. This can offer some resilience against minor supply disruptions compared to smaller, less diversified manufacturers. However, Teva, like all generic players, operates within the stringent pricing environment dictated by PBMs and competitive forces. Price changes for this specific NDC will largely mirror the broader market trends for 137 mcg levothyroxine tablets.
Key Takeaways
- NDC 51407-0381, Levothyroxine Sodium Tablets, 137 mcg, operates in a mature, highly competitive generic market.
- Pricing is primarily influenced by generic competition, payer negotiations, and supply chain dynamics rather than R&D costs.
- Current pricing exhibits stability with a slight downward pressure on net prices due to payer leverage.
- Future price projections indicate continued stability with potential for minor fluctuations. Significant price increases are unlikely unless severe supply chain disruptions occur.
- Long-term price trends will depend on the sustainability of generic manufacturing economics and global API sourcing stability.
Frequently Asked Questions
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What is the primary indication for levothyroxine sodium tablets? Levothyroxine sodium tablets are primarily prescribed for the treatment of hypothyroidism, a condition characterized by an underactive thyroid gland.
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How does the price of generic levothyroxine compare to brand-name Synthroid? Generic levothyroxine, including products like NDC 51407-0381, is significantly less expensive than brand-name Synthroid due to the absence of R&D recoupment costs and intense market competition among generic manufacturers.
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Are there any known supply chain risks specific to levothyroxine manufacturing? As with many generic drugs, levothyroxine manufacturing is reliant on global API suppliers. Risks include potential disruptions in API sourcing, quality control issues, and manufacturing capacity limitations that can impact availability and pricing.
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What role do Pharmacy Benefit Managers (PBMs) play in levothyroxine pricing? PBMs are critical. They negotiate rebates and discounts with pharmaceutical manufacturers and establish formularies that dictate which drugs are preferred. These negotiations heavily influence the net price of levothyroxine for payers and, indirectly, for consumers.
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Can NDC 51407-0381 be subject to significant price increases due to patent expiration? NDC 51407-0381 is a generic product. Its pricing is not directly affected by patent expiration of a brand-name drug, but rather by the ongoing competition among multiple generic manufacturers, which has been in place for many years.
Citations
[1] U.S. Food & Drug Administration. (n.d.). NDC 51407-0381 - Levothyroxine Sodium Tablets, USP. National Drug Code Directory. [2] National Institute of Diabetes and Digestive and Kidney Diseases. (2023, April). Thyroid Disease. U.S. Department of Health and Human Services. [3] Kesselheim, A. S., & Choudhury, S. (2020). The Problem of Drug Shortages. New England Journal of Medicine, 382(12), 1149–1154.
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