Introduction to Liothyronine Sodium Tablets
Liothyronine sodium tablets, with the NDC code 00093-2178, are a generic version of the brand-name drug Cytomel®, used primarily for the treatment of hypothyroidism. These tablets are manufactured by Teva Pharmaceuticals USA, Inc.[1][3].
Therapeutic Category and Use
Liothyronine sodium tablets fall under the therapeutic category of thyroid and antithyroid agents. They are indicated as a replacement therapy in primary, secondary, and tertiary hypothyroidism, as well as for TSH suppression in well-differentiated thyroid cancer[1].
Market Size and Growth Projections
The US pharmaceutical market, which includes drugs like liothyronine sodium, is projected to grow significantly. From $846.72 billion in 2022, the market is expected to reach $1.28 trillion by 2030, with a Compound Annual Growth Rate (CAGR) of 5.36%. This growth is driven by factors such as rising pharmaceutical production capacity, greater approvals of generic drugs, and escalating R&D investments[2].
Pricing Mechanisms
Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)
For drugs covered under the Medicaid Drug Rebate Program, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) and then adjusting for package size and case pack size. This formula ensures that the price charged to 340B covered entities is no greater than the statutory pricing formula[2].
Historical Pricing Data
To project prices for liothyronine sodium tablets (NDC 00093-2178), it is essential to review historical pricing data. Generic drugs, in general, tend to see price erosion annually by mid-single-digit percentages. This trend is consistent with the current outlook in the generic drug market[4].
Regulatory Changes
Regulatory changes, such as updates to the Medicaid Drug Rebate Program or new FDA guidelines, can significantly impact pricing. For instance, changes in rebate amounts or adjustments in the AMP can alter the ceiling price for covered outpatient drugs[2].
Market Demand and Competition
The demand for liothyronine sodium tablets and the level of competition in the market are crucial factors influencing pricing. Since liothyronine sodium is a widely used drug for hypothyroidism, its demand is relatively stable. However, competition from other generic versions and potential biosimilars can lead to more stable or even decreasing prices over time[2].
Technological Advancements
Technological advancements, such as the adoption of AI in drug discovery and manufacturing, can reduce development and manufacturing costs. This could potentially lead to lower prices for liothyronine sodium tablets as manufacturers pass on the savings to consumers[2].
Example Calculation for 340B Ceiling Price
To illustrate the pricing mechanism, consider the following hypothetical example:
- AMP: $50 per unit
- URA: $10 per unit
- Package Size: 30 units
- Case Pack Size: 10 packages
[ \text{340B Ceiling Price} = (50 - 10) \times 30 \times 10 = \$12,000 ]
This calculation provides a baseline for the ceiling price, but actual market prices can vary based on various factors including market demand, competition, and regulatory changes[2].
Price Projections
Given the stable demand for liothyronine sodium tablets and the competitive nature of the generic drug market, prices are likely to remain stable or decrease slightly over the next few years. Here are some key points to consider:
- Historical Data: Prices for generic drugs typically erode by mid-single-digit percentages annually.
- Regulatory Changes: Any updates to rebate programs or FDA guidelines could impact pricing.
- Market Demand: Stable demand for hypothyroidism treatment ensures a consistent market for the drug.
- Competition: Presence of multiple generic versions keeps prices competitive.
Key Takeaways
- Market Growth: The US pharmaceutical market is expected to grow significantly by 2030.
- Pricing Mechanisms: AMP and URA are crucial in calculating ceiling prices for covered outpatient drugs.
- Historical Data: Reviewing historical pricing trends is essential for projecting future prices.
- Regulatory and Market Factors: Changes in regulations, market demand, and competition influence price projections.
FAQs
Q: What is the significance of the NDC code 00093-2178?
A: The NDC code 00093-2178 identifies liothyronine sodium tablets, a generic version of Cytomel®, used for treating hypothyroidism.
Q: How is the 340B ceiling price calculated for liothyronine sodium tablets?
A: The 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) and then adjusting for package size and case pack size.
Q: What factors influence the price of liothyronine sodium tablets?
A: Historical pricing data, regulatory changes, market demand, competition, and technological advancements influence the price of liothyronine sodium tablets.
Q: How does the adoption of AI impact drug pricing?
A: The adoption of AI can reduce development and manufacturing costs, potentially leading to lower prices for drugs like liothyronine sodium tablets.
Q: What is the projected growth of the US pharmaceutical market?
A: The US pharmaceutical market is projected to grow from $846.72 billion in 2022 to $1.28 trillion by 2030, with a CAGR of 5.36%.
Sources:
- DailyMed - Liothyronine Sodium tablet - DailyMed
- DrugPatentWatch - Latest pharmaceutical drug prices and trends for NDC 00093-7662
- Teva Pharmaceuticals USA - Liothyronine Sodium Tablets USP
- DrugPatentWatch - Latest drug prices and trends for NDC 00093-8739