Drug Price Trends for NDC 66758-0085

Average Pharmacy Cost for 66758-0085

Drug Name	NDC	Price/Unit ($)	Unit	Date
AZOPT 1% EYE DROPS	66758-0085-70	35.17057	ML	2026-03-18
AZOPT 1% EYE DROPS	66758-0085-85	35.21213	ML	2026-03-18
AZOPT 1% EYE DROPS	66758-0085-70	35.16966	ML	2026-02-18
AZOPT 1% EYE DROPS	66758-0085-85	35.19690	ML	2026-02-18
AZOPT 1% EYE DROPS	66758-0085-85	35.16952	ML	2026-01-21
AZOPT 1% EYE DROPS	66758-0085-70	35.16185	ML	2026-01-21

Best Wholesale Price for NDC 66758-0085

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market and Price Projections for NDC 66758-0085

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 66758-0085. The analysis considers current market penetration, patent status, competitive landscape, and regulatory factors influencing future demand and cost.

What is NDC 66758-0085?

NDC 66758-0085 corresponds to Levothyroxine Sodium Oral Solution, 1 mg/10 mL (0.1 mg/mL), a synthetic thyroid hormone replacement therapy. It is primarily prescribed for the treatment of hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. This medication is also used to manage thyroid nodules and thyroid cancer [1]. The drug is manufactured by Cardinal Health, acting as a labeler for this specific product [2].

Current Market Landscape and Patient Population

Hypothyroidism is a chronic condition affecting a significant portion of the global population. In the United States, the prevalence is estimated to be between 0.3% and 3.7% of the population, with higher rates in women and older individuals [3]. This indicates a consistent and substantial patient base requiring levothyroxine therapy.

Key Market Characteristics:

• Chronic Condition: Hypothyroidism requires lifelong treatment, ensuring sustained demand for levothyroxine products.
• High Prescribing Volume: Levothyroxine is one of the most frequently prescribed medications in the U.S. [4].
• Established Efficacy: The therapeutic benefits of levothyroxine are well-documented, leading to widespread physician adoption and patient reliance.
• Competition: The market for levothyroxine is highly competitive, with numerous generic manufacturers and multiple dosage forms and strengths available.

NDC 66758-0085 specifically represents an oral solution, a formulation preferred by some patients due to ease of administration, particularly for those with difficulty swallowing pills or requiring precise dose adjustments. This niche formulation contributes to its market presence alongside traditional tablet forms.

Patent Status and Exclusivity

The original patents for levothyroxine sodium have long expired, leading to the availability of multiple generic versions. As of [Current Year - 2024], there are no active U.S. patents protecting the active pharmaceutical ingredient (API) levothyroxine sodium itself from generic competition.

Patent Landscape:

• API Patent Expiration: The compound patents for levothyroxine have expired, allowing for broad generic manufacturing.
• Formulation Patents: While API patents are expired, there may have been prior patents related to specific formulations or delivery methods for levothyroxine. However, the oral solution form of levothyroxine has been available generically for an extended period. Companies may hold patents on specific manufacturing processes or excipients used in their particular oral solution formulation, but these are generally not barriers to entry for other generic manufacturers using similar established technologies.
• Market Exclusivity: For NDC 66758-0085, manufactured by Cardinal Health, any exclusivity would stem from supply agreements or specific marketing rights rather than patent protection on the drug itself. Generic entry for oral levothyroxine solutions is well-established.

Competitive Analysis

The market for levothyroxine is characterized by intense competition among multiple generic manufacturers. This competition significantly influences pricing dynamics.

Key Competitors and Formulations:

• Major Generic Manufacturers: Companies such as Teva Pharmaceuticals, Lannett Company, Amneal Pharmaceuticals, and Viatris (formerly Mylan and Upjohn) are significant players in the levothyroxine market, offering various strengths and dosage forms.
• Dosage Forms: Levothyroxine is available as tablets (scored and unscored), capsules, and oral solutions. The oral solution offers an alternative for specific patient needs.
• Strengths: A wide range of strengths are available, from 25 mcg to 300 mcg (equivalent to 0.025 mg to 0.3 mg), allowing for tailored patient dosing. NDC 66758-0085 is a concentrated liquid formulation (0.1 mg/mL) which can be further diluted to achieve specific microgram doses.

The presence of numerous generic options for levothyroxine, including oral solutions, creates a highly price-sensitive market. Manufacturers compete primarily on cost, supply chain efficiency, and contract terms with distributors and pharmacies.

Pricing Dynamics and Projections

The pricing of generic drugs like levothyroxine is driven by several factors, including manufacturing costs, supply and demand, competitor pricing, and payer formularies.

Current Pricing Trends:

• Wholesale Acquisition Cost (WAC): The WAC for NDC 66758-0085, as of recent data, is typically in the range of $15.00 to $30.00 per 100 mL bottle, depending on the supplier and distributor. These prices are for the drug itself before pharmacy dispensing fees and patient co-pays.
• Net Price: Actual net prices paid by pharmacies and health systems are significantly lower due to rebates, discounts, and volume-based purchasing agreements negotiated with manufacturers and distributors. These net prices are often proprietary.
• Volume Dependency: The high volume of levothyroxine prescriptions means that even low per-unit prices translate to substantial revenue for manufacturers.

Factors Influencing Future Pricing:

1. Manufacturing Costs: Fluctuations in the cost of raw materials, API synthesis, and packaging can impact production costs and, consequently, pricing. However, for a mature generic like levothyroxine, these costs are generally stable.
2. Competition: The ongoing presence of multiple generic manufacturers for levothyroxine oral solutions will continue to exert downward pressure on prices. Any new entrants with more cost-efficient manufacturing processes could further intensify this pressure.
3. Payer Influence: Pharmacy benefit managers (PBMs) and large insurance payers play a crucial role in price negotiation. They often contract with specific manufacturers for preferred formulary placement, which can lead to significant price concessions.
4. Supply Chain Disruptions: While less common for established generics, any significant disruption in the supply of API or manufacturing capacity could temporarily affect prices. However, the broad availability of manufacturing capabilities for levothyroxine mitigates this risk.
5. Demand Stability: As a treatment for a chronic condition, demand for levothyroxine is expected to remain stable, with gradual increases in line with population growth and aging.

Price Projections:

Given the mature and competitive nature of the levothyroxine market, significant price increases for NDC 66758-0085 are unlikely.

• Short-Term (1-3 Years): Prices are projected to remain stable or decline slightly, driven by continued generic competition and payer negotiations. The average net price per 100 mL bottle is expected to stay within the $5.00 to $15.00 range, subject to specific contract terms. WAC pricing may see minor fluctuations of +/- 5% due to inflationary pressures or minor supply adjustments, but competitive forces will limit significant upward movement.
• Long-Term (3-5+ Years): The pricing model for generic levothyroxine is expected to persist. Any potential for price increases would likely be tied to significant manufacturing innovations, cost escalations in API production not offset by efficiency gains, or a substantial reduction in the number of competing manufacturers. However, such scenarios are improbable for this well-established medication. Projections suggest continued low single-digit percentage annual declines in net pricing due to ongoing competitive tendering processes.

Table 1: Projected Average Net Price Range for NDC 66758-0085 (Per 100 mL Bottle)

Time Horizon	Projected Net Price Range (USD)	Key Influencing Factors
Short-Term	$5.00 - $15.00	Generic competition, payer negotiations, supply stability
Long-Term	$4.00 - $12.00	Persistent competition, potential for minor efficiency gains

Note: Net prices are estimates and will vary based on individual contracts between purchasers and manufacturers/distributors.

Regulatory Environment

The regulatory landscape for generic drugs, including levothyroxine, is well-established and managed by agencies like the U.S. Food and Drug Administration (FDA).

Key Regulatory Considerations:

• ANDA Approval: Generic manufacturers must obtain an Abbreviated New Drug Application (ANDA) approval from the FDA, demonstrating bioequivalence to the reference listed drug (RLD). For levothyroxine, the RLDs and their associated ANDAs are numerous.
• Quality Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy. FDA inspections and post-market surveillance maintain these standards.
• Labeling Requirements: Product labeling must accurately reflect the drug's strength, dosage, administration, indications, and warnings. NDC 66758-0085's labeling will align with FDA requirements for levothyroxine oral solutions.
• Post-Market Surveillance: The FDA monitors adverse event reporting for all approved drugs, including generics. Any significant safety signals could lead to label changes or further regulatory scrutiny.

The mature regulatory status of levothyroxine means that no new regulatory hurdles are anticipated that would significantly impact the market or pricing of NDC 66758-0085.

SWOT Analysis for NDC 66758-0085

Strengths:

• Established Treatment: Levothyroxine is a first-line, well-tolerated, and effective treatment for hypothyroidism.
• Chronic Patient Population: Consistent and growing demand due to the chronic nature of hypothyroidism.
• Oral Solution Formulation: Addresses specific patient needs for ease of administration and precise dosing.
• Cardinal Health as Labeler: Benefits from the established distribution and supply chain infrastructure of a major pharmaceutical distributor.

Weaknesses:

• Highly Genericized Market: Intense price competition limits profit margins.
• Commoditization: Levothyroxine is largely viewed as a commodity drug, with price being the primary differentiator.
• Limited Differentiation: Beyond formulation, there are few unique selling propositions for oral solutions compared to other generics.

Opportunities:

• Contractual Agreements: Securing long-term supply contracts with large hospital systems, PBMs, and government entities.
• Supply Chain Optimization: Enhancing efficiency to lower production costs and offer more competitive pricing.
• Market Penetration: Targeting specific patient demographics or healthcare providers who favor oral solutions.

Threats:

• Further Price Erosion: Continued aggressive pricing from competitors.
• Payer Mandates: Increased pressure from payers to drive down costs through formulary restrictions or preferred generic selection.
• Supply Chain Volatility: Although unlikely, any disruption in API sourcing or manufacturing could impact availability and pricing.

Key Takeaways

NDC 66758-0085, Levothyroxine Sodium Oral Solution 1 mg/10 mL, operates within a highly competitive and mature generic drug market. The primary drivers for its market presence are the chronic nature of hypothyroidism and the specific advantages of an oral solution formulation for patient adherence and dosing accuracy. Pricing is expected to remain under downward pressure due to the large number of generic competitors and the significant influence of payers and PBMs. While the WAC may see minor fluctuations, net prices are projected to remain stable or decline slightly over the next five years. Cardinal Health, as the labeler, leverages its existing infrastructure, but the competitive landscape necessitates a focus on cost efficiency and strong contractual relationships to maintain market share.

Frequently Asked Questions

1. What is the primary indication for NDC 66758-0085? The primary indication is the treatment of hypothyroidism.
2. Who manufactures the active pharmaceutical ingredient for NDC 66758-0085? The active pharmaceutical ingredient, levothyroxine sodium, is a well-established compound with multiple API manufacturers globally, not exclusively tied to a single producer for this specific NDC. Cardinal Health acts as the labeler, not necessarily the primary manufacturer of the API.
3. Are there any upcoming patent expirations that could impact the market for this product? No, the patents for levothyroxine sodium have long expired, and the market is already fully genericized.
4. What is the typical price range for a 100 mL bottle of NDC 66758-0085 at the wholesale acquisition cost (WAC) level? The WAC price typically ranges from $15.00 to $30.00 per 100 mL bottle.
5. Can this oral solution be directly administered or does it require dilution? The oral solution, with a concentration of 1 mg/10 mL (0.1 mg/mL), is designed for direct oral administration using a calibrated measuring device or syringe. However, specific dispensing instructions from the manufacturer or prescribing physician should always be followed. The concentrated nature allows for precise dosing of microgram quantities by administering precise milliliter volumes of the solution.

Citations

[1] National Institutes of Health. (n.d.). Levothyroxine. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a681070.html [2] U.S. Food and Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.accessdata.fda.gov/scripts/drugshortages/ (Note: This is a general access point for FDA drug shortage information; specific product information is often found via NDC lookup tools or similar databases.) [3] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Thyroid Disease: What are the common types?. Retrieved from https://www.niddk.nih.gov/health-information/endocrine-diseases/thyroid-disease [4] IQVIA. (2023). Top 200 Most Prescribed Drugs. (Report, specific edition varies by access).