Last updated: February 22, 2026
What is the Drug Identified by NDC 60429-0893?
NDC 60429-0893 refers to a specialty drug marketed under the brand name Tirosint-SOL (liquid capsule formulation of levothyroxine sodium). It is used for hypothyroidism treatment in adults and children. Manufactured by IBSA Institut Biochimque SA, the drug is an alternative to traditional levothyroxine tablets, offering potential benefits for patients with swallowing difficulties or malabsorption issues.
Market Size and Demand Drivers
Population Demographics
- Estimated hypothyroidism prevalence: 4.6% of the U.S. population (approx. 12 million people) [1].
- Tirosint-SOL primarily targets adults with hypothyroidism, including those with malabsorption conditions or difficulties swallowing pills.
Prescription Trends
- Levothyroxine is among the most prescribed medications in the U.S., with over 115 million prescriptions annually [2].
- Liquid formulations like Tirosint-SOL represent a subset, estimated at 5-8% of total levothyroxine prescriptions, driven by an aging population and increased diagnosis rates.
Market Penetration Factors
- Growing awareness of absorption issues with tablet forms.
- Physician preference shifting toward liquid formulations for specific patient profiles.
- Insurance coverage and formulary inclusion influence access and demand.
Competitive Landscape
Key Competitors
| Product Name |
Dosage Form |
Price Range (per 30-day supply) |
Market Share |
Manufacturer |
| Tirosint-SOL |
Liquid capsule |
$65 - $85 |
10-12% |
IBSA Institut Biochimque |
| Synthroid (Levothyroxine) |
Tablet |
$7 - $15 |
70-75% |
AbbVie |
| Levoxyl |
Tablet |
$7 - $12 |
10-12% |
Pfizer |
| Euthyrox (stellmed) |
Tablet (international) |
Variable |
Small |
Merck KGaA |
Product Differentiation
- Tirosint-SOL offers liquid formulation for better absorption.
- Price premium: Tirosint-SOL costs approximately 4-6 times more than tablet equivalents.
- Limited by insurance formularies; reimbursement can vary significantly.
Pricing Trends and Projections
Current Pricing
- The average retail price for Tirosint-SOL is approximately $70 to $85 per 30-day supply.
- Insurance copays range from $15 to $50, depending on coverage.
Factors Influencing Price Changes
- Manufacturing costs: Increased costs of raw materials or formulation changes.
- Market competition: Entry of new liquid formulations or generics could pressure prices.
- Regulatory changes: Expanded indications or new formulations could influence pricing strategies.
- Payer negotiations: Favorable formulary placement can reduce out-of-pocket costs, but may create pricing pressure.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price Range (per 30-day supply) |
Key Drivers |
| 2023 |
$70 - $85 |
Stable demand; limited generic competition |
| 2024-2025 |
$75 - $90 |
Slight inflation; increased utilization |
| 2026-2028 |
$80 - $100 |
Potential entry of generic versions; increased competition |
| 2029+ |
$85 - $110 |
Market stabilization; inflation adjustments |
Note: Prices are projected with conservative growth, allowing for generic entry and price competition.
Market Entry and Regulatory Outlook
- No approved generics as of 2023.
- Patent protections likely to expire around 2030, potentially opening competitive bidding.
- FDA approval processes for liquid formulations are efficient, but new entrants would need to demonstrate bioequivalence.
Key Risks and Opportunities
Risks
- Delays in insurance coverage expansion.
- Introduction of generic alternatives lowering prices.
- Changes in clinical guidelines favoring tablet-based therapies.
Opportunities
- Increased adoption driven by unmet needs for patients with absorption issues.
- Expansion into international markets with high hypothyroidism prevalence.
- Development of combination therapies or formulations with improved bioavailability.
Final Summary
Tirosint-SOL (NDC 60429-0893) occupies a niche within the hypothyroidism treatment market, benefiting from its formulation advantages. Pricing remains premium due to brand positioning and limited competition. Demand growth correlates with the hypothyroidism population and physician preference for absorption issues. Price projections suggest moderate increases driven by market maturation, potential generic entry, and inflation.
Key Takeaways
- Tirosint-SOL’s current retail price is approximately $70-$85 per month, with expectations of slight increases over five years.
- The market is dominated by cheaper tablet formulations, with liquid products capturing ~10% of prescriptions.
- Patent expiration around 2030 could open opportunities for generics, impacting prices.
- Insurance coverage remains a critical factor influencing out-of-pocket costs.
- Growing recognition of absorption benefits may expand Tirosint-SOL’s market share.
FAQs
1. When is patent expiration expected for Tirosint-SOL?
Around 2030, which could enable generic competition.
2. How does insurance coverage affect Tirosint-SOL pricing?
Insurance copays can significantly reduce patient costs, but formulary access varies, affecting overall demand.
3. Are there generic equivalents available?
As of 2023, no FDA-approved generics. Pending patent expiry, generics are anticipated.
4. Could new formulations impact Tirosint-SOL’s market share?
Yes, especially if they offer similar benefits at lower prices.
5. What are the primary drivers of demand for Tirosint-SOL?
Physicians prescribing for patients with absorption issues, swallowing difficulties, or malabsorption syndromes.
References
[1] American Thyroid Association. (2020). Hypothyroidism facts and figures.
[2] IQVIA. (2022). Prescription data for levothyroxine products.
