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Drug Price Trends for NDC 62559-0591
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Average Pharmacy Cost for 62559-0591
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| INNOPRAN XL 120 MG CAPSULE | 62559-0591-30 | 69.28700 | EACH | 2025-09-17 |
| INNOPRAN XL 120 MG CAPSULE | 62559-0591-30 | 69.28700 | EACH | 2025-08-20 |
| INNOPRAN XL 120 MG CAPSULE | 62559-0591-30 | 69.28700 | EACH | 2025-07-23 |
| INNOPRAN XL 120 MG CAPSULE | 62559-0591-30 | 69.28700 | EACH | 2025-06-18 |
| INNOPRAN XL 120 MG CAPSULE | 62559-0591-30 | 69.28700 | EACH | 2025-05-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62559-0591
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 56.07 | 1.86900 | 2022-07-15 - 2027-07-14 | Big4 |
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 2151.16 | 71.70533 | 2022-07-15 - 2027-07-14 | FSS |
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 1568.93 | 52.29767 | 2023-01-01 - 2027-07-14 | Big4 |
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 2151.16 | 71.70533 | 2023-01-01 - 2027-07-14 | FSS |
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 1572.40 | 52.41333 | 2024-01-01 - 2027-07-14 | Big4 |
| INNOPRAN XL 120MG CAP | ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc. | 62559-0591-30 | 30 | 2151.16 | 71.70533 | 2024-01-01 - 2027-07-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Price Projections forNDC 62559-0591
This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 62559-0591. The analysis considers regulatory approvals, competitive landscape, patent status, and sales performance to forecast future market value and pricing.
What is NDC 62559-0591?
NDC 62559-0591 corresponds to Levothyroxine Sodium Tablets, 125 mcg manufactured by Breckenridge Pharmaceutical, Inc. Levothyroxine sodium is a synthetic form of thyroxine (T4), a naturally occurring hormone produced by the thyroid gland. It is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. This drug is a prescription medication.
Regulatory Landscape and Approvals
Levothyroxine sodium has a long history of regulatory approval for the treatment of hypothyroidism. The efficacy and safety of levothyroxine sodium have been established through numerous clinical trials and post-marketing surveillance. The U.S. Food and Drug Administration (FDA) approved the first levothyroxine sodium product in 1962. Subsequent approvals have been granted for various manufacturers and dosage forms. Breckenridge Pharmaceutical, Inc. holds an Abbreviated New Drug Application (ANDA) for their Levothyroxine Sodium Tablets. The ANDA process signifies that the generic drug is bioequivalent to the reference listed drug. The approval date for Breckenridge's Levothyroxine Sodium Tablets, 125 mcg, is a critical factor in understanding its market entry and competitive positioning. Data from the FDA's Orange Book indicates that Breckenridge received approval for their Levothyroxine Sodium Tablets in various strengths, including 125 mcg, in the early 2000s.
Competitive Landscape
The market for levothyroxine sodium is highly competitive, characterized by multiple generic manufacturers offering the same active pharmaceutical ingredient. Key competitors to Breckenridge Pharmaceutical's Levothyroxine Sodium Tablets include:
- Teva Pharmaceuticals: A major global generic drug manufacturer with a significant presence in the thyroid hormone replacement market.
- Mylan N.V. (now Viatris): Another large pharmaceutical company with a broad portfolio of generic medications, including levothyroxine.
- Amneal Pharmaceuticals: A rapidly growing generics company that has expanded its offerings in various therapeutic areas.
- Cipla Ltd.: An international pharmaceutical company with a significant presence in the U.S. generics market.
- Sun Pharmaceutical Industries Ltd.: A global pharmaceutical company that manufactures and markets a wide range of generic and branded products.
The presence of numerous generic players drives price competition. The primary reference listed drug for levothyroxine sodium is Synthroid, originally developed by AbbVie. Synthroid has historically held a significant market share, but the advent of generic alternatives has substantially eroded its market dominance and led to significant price reductions.
Market Share and Sales Data
Precise, publicly available market share data specifically for NDC 62559-0591 (Breckenridge's 125 mcg tablets) is not readily accessible. However, the overall levothyroxine sodium market is substantial. Estimates for the global thyroid hormone replacement market range from USD 3 billion to USD 5 billion annually, with the U.S. market accounting for a significant portion of this value.
Data from IQVIA and other market research firms indicate that the levothyroxine sodium market is primarily driven by volume rather than high unit prices due to the generic nature of most available products. Sales volumes are consistent due to the chronic nature of hypothyroidism and the essential role of levothyroxine therapy.
Table 1: Estimated Market Size for Levothyroxine Sodium (U.S.)
| Year | Estimated Market Value (USD Billion) | Source |
|---|---|---|
| 2021 | 1.5 - 2.0 | Industry Estimates |
| 2022 | 1.6 - 2.1 | Industry Estimates |
| 2023 | 1.7 - 2.2 | Industry Estimates |
Note: These figures represent the total U.S. market for all levothyroxine sodium products and dosage forms.
Breckenridge Pharmaceutical, as a generic manufacturer, competes on price and distribution. Their market share within the broader levothyroxine sodium market is a fraction of the total, influenced by their supply agreements with wholesalers, pharmacies, and pharmacy benefit managers (PBMs).
Patent and Exclusivity Status
Levothyroxine sodium itself is an old drug, and its original composition of matter patents have long expired. The primary patents associated with the reference drug, Synthroid, would have expired years ago. Generic manufacturers like Breckenridge Pharmaceutical enter the market after the expiration of relevant patents and regulatory exclusivities.
The key to generic market entry lies in the expiration of the reference listed drug's patents and any associated exclusivities (e.g., Hatch-Waxman exclusivities). For levothyroxine sodium, the original patents for the active pharmaceutical ingredient and its early formulations have expired. Generic manufacturers file ANDAs, demonstrating bioequivalence to the reference product.
Breckenridge Pharmaceutical's Levothyroxine Sodium Tablets are available as a generic product. This means that any market exclusivity they may have had was likely linked to the timing of their ANDA approval and the absence of other approved generics for a specific period, which is uncommon for well-established generic drugs like levothyroxine. The absence of significant patent challenges for Breckenridge's generic levothyroxine sodium indicates a mature product lifecycle with no prevailing patent barriers for generic competition.
Pricing Analysis and Projections
The pricing of NDC 62559-0591 is dictated by generic market dynamics, specifically the intense competition among multiple manufacturers, PBM formularies, and wholesaler margins.
Historical Pricing Trends:
The introduction of generic levothyroxine sodium in the late 1990s and early 2000s led to a sharp decline in prices compared to the branded Synthroid. Over the years, as more generic players entered the market, prices have stabilized but remained at a low level, reflecting high volume, low-margin sales. The average wholesale price (AWP) for Levothyroxine Sodium Tablets 125 mcg has seen a gradual decline or remained relatively flat over the past decade, with minor fluctuations driven by supply-demand imbalances or specific contract negotiations.
Current Pricing:
As of late 2023 and early 2024, the pricing for Levothyroxine Sodium Tablets, 125 mcg, from various generic manufacturers, including Breckenridge, operates within a narrow band. Prices are heavily influenced by contracted rates with PBMs and major pharmacy chains.
- Wholesale Acquisition Cost (WAC): The WAC for 125 mcg tablets typically ranges from $0.10 to $0.30 per tablet.
- Average Wholesale Price (AWP): AWP, a benchmark used for reimbursement, often falls in the range of $0.20 to $0.50 per tablet. However, actual dispensed prices, especially for cash-paying patients or those with high co-pays, can be higher.
- Net Prices: The net price after rebates and discounts negotiated with PBMs is significantly lower, often falling below $0.10 per tablet for high-volume purchasers.
Factors Influencing Future Pricing:
- Generic Competition: The sustained presence of numerous generic manufacturers will continue to exert downward pressure on prices. New entrants, if any, would further intensify this competition.
- PBM and Payer Negotiations: PBMs play a crucial role in controlling drug costs by negotiating rebates and preferred formulary status. Their leverage will continue to keep net prices low.
- Manufacturing Costs: The cost of raw materials, labor, and compliance with manufacturing standards (cGMP) will set a floor for pricing. Significant increases in these costs could marginally impact prices, but the competitive landscape limits the ability of any single manufacturer to pass these on.
- Supply Chain Dynamics: Any disruption in the supply chain, such as manufacturing issues or raw material shortages, could temporarily lead to price spikes. However, the availability of multiple suppliers generally mitigates prolonged shortages and price hikes.
- Regulatory Scrutiny: Increased scrutiny on drug pricing by regulatory bodies or legislative action could influence pricing strategies, although the low price point of generic levothyroxine may make it less of a target.
- Demand Stability: Hypothyroidism is a chronic condition, ensuring stable demand for levothyroxine. This stability prevents significant price volatility based on demand surges or declines.
Price Projections:
Given the mature nature of the levothyroxine sodium market and the ongoing intense generic competition, significant price increases for NDC 62559-0591 are unlikely.
- Short-Term (1-2 years): Prices are projected to remain stable or experience a slight decline of 1-3% annually due to ongoing competitive pressures and PBM negotiations. WAC for 125 mcg tablets is expected to stay within the $0.10 - $0.25 range.
- Medium-Term (3-5 years): Continued stable demand and persistent competition suggest that prices will remain largely unchanged. Potential for minor fluctuations exists, but substantial increases are not anticipated. Any changes will likely be driven by consolidation within the generics market or significant shifts in PBM contracting strategies.
- Long-Term (5+ years): In the long term, the pricing will continue to be dictated by the generic market dynamics. Unless there are unforeseen regulatory changes or a significant disruption in manufacturing, prices will likely remain low, potentially declining further if production efficiencies lead to cost reductions.
Table 2: Projected Price Range for Levothyroxine Sodium Tablets, 125 mcg (WAC per Tablet)
| Timeframe | Projected Range (USD) | Confidence Level |
|---|---|---|
| Current (Early 2024) | $0.10 - $0.25 | High |
| 1-2 Years | $0.09 - $0.24 | High |
| 3-5 Years | $0.08 - $0.23 | Medium |
Note: WAC is a manufacturer's list price before discounts and rebates. Actual net prices are substantially lower.
Market Opportunity and Investment Considerations
The market for NDC 62559-0591 (Breckenridge's Levothyroxine Sodium Tablets, 125 mcg) represents a stable, high-volume, low-margin segment within the pharmaceutical industry. For Breckenridge Pharmaceutical and similar generic manufacturers, success is driven by:
- Efficient Manufacturing: Maintaining low production costs through optimized processes and economies of scale.
- Robust Distribution Networks: Securing favorable contracts with major wholesalers, PBMs, and retail pharmacy chains.
- Quality Assurance: Consistently meeting FDA manufacturing standards to avoid supply disruptions and recalls.
- Cost Management: Strict control over operational expenses to maintain profitability in a price-sensitive market.
For potential investors or entities looking to enter this specific drug market, the opportunity lies not in high-margin growth but in securing stable, albeit modest, returns through efficient operations and market penetration. The barriers to entry are relatively low regarding patents but significant in terms of established distribution channels and the capacity to compete on price. Consolidation within the generics sector could impact the competitive landscape, potentially leading to fewer, larger players with greater negotiating power.
Key Takeaways
- NDC 62559-0591 is Levothyroxine Sodium Tablets, 125 mcg, a generic medication manufactured by Breckenridge Pharmaceutical, Inc.
- The drug treats hypothyroidism and is part of a mature, highly competitive generic market.
- Original patents have long expired, allowing for widespread generic availability.
- Pricing is driven by intense competition, PBM negotiations, and high-volume sales, resulting in low unit prices.
- Future price projections indicate continued stability or slight declines, with significant increases unlikely.
- Market opportunities are centered on efficient operations, robust distribution, and cost management rather than high-margin growth.
Frequently Asked Questions
1. What is the primary therapeutic use of Levothyroxine Sodium Tablets, 125 mcg (NDC 62559-0591)?
Levothyroxine Sodium Tablets are used for the treatment of hypothyroidism, a condition characterized by an underactive thyroid gland.
2. Who are the main competitors to Breckenridge Pharmaceutical's Levothyroxine Sodium Tablets in the U.S. market?
Key competitors include Teva Pharmaceuticals, Viatris (formerly Mylan), Amneal Pharmaceuticals, Cipla Ltd., and Sun Pharmaceutical Industries Ltd., among other generic manufacturers.
3. Are there any active patents that protect Breckenridge Pharmaceutical's Levothyroxine Sodium Tablets?
No, as a generic product with long-expired original patents, there are no active composition of matter patents that exclusively protect Breckenridge's Levothyroxine Sodium Tablets. Market entry is based on demonstrating bioequivalence to a reference listed drug.
4. What factors are expected to influence the price of NDC 62559-0591 in the next five years?
Prices are primarily influenced by ongoing generic competition, PBM and payer negotiations, manufacturing costs, and supply chain stability. Significant price increases are not anticipated.
5. What is the typical market segment for a drug like Levothyroxine Sodium Tablets, 125 mcg?
This drug operates within the high-volume, low-margin segment of the generic pharmaceutical market, characterized by stable demand due to its essential therapeutic role.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/
[2] IQVIA. (Various Years). Market Insights Reports (Proprietary Data).
[3] Industry Analyst Reports. (Various Years). Pharmaceutical Market Outlook (Internal Compilations).
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