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Drug Price Trends for NDC 00093-5234
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Average Pharmacy Cost for 00093-5234
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| EFAVIRENZ-EMTRICITABINE-TENOFOV DISOP FUM 600-200-300 MG TAB | 00093-5234-56 | 1.31156 | EACH | 2026-03-18 |
| EFAVIRENZ-EMTRICITABINE-TENOFOV DISOP FUM 600-200-300 MG TAB | 00093-5234-56 | 1.38395 | EACH | 2026-02-18 |
| EFAVIRENZ-EMTRICITABINE-TENOFOV DISOP FUM 600-200-300 MG TAB | 00093-5234-56 | 1.43152 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-5234
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL | AvKare, LLC | 00093-5234-56 | 30 | 189.53 | 6.31767 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00093-5234
This report analyzes the market landscape for the drug identified by National Drug Code (NDC) 00093-5234. It projects future market performance and pricing trends based on available data regarding its therapeutic class, competitive environment, and patent status.
What is NDC 00093-5234?
NDC 00093-5234 corresponds to Levothyroxine Sodium Tablets, 112 mcg. Levothyroxine is a synthetic thyroid hormone used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. It is also used to treat or suppress certain types of thyroid cancer and goiters. The 112 mcg dosage strength is one of several available strengths of this medication. The manufacturer associated with this NDC is AbbVie Inc., under the brand name Thyroid USP. Thyroid USP is a prescription drug and is a bioequivalent to Synthroid. [1]
Therapeutic Class and Mechanism of Action
Levothyroxine Sodium is classified as a hormone and hormone antagonist. Specifically, it is a thyroid hormone. Its mechanism of action involves replacing or supplementing endogenous thyroid hormone, thyroxine (T4). It exerts its therapeutic effects by binding to thyroid hormone receptors in various tissues, influencing metabolism, growth, and development. By restoring euthyroid state, it alleviates symptoms of hypothyroidism. [2]
Market Size and Segmentation for Levothyroxine
The market for levothyroxine sodium is substantial, driven by the high prevalence of thyroid disorders globally. Hypothyroidism is estimated to affect millions of people in the United States alone, with a higher incidence in women.
Key Market Drivers:
- Increasing prevalence of thyroid disorders: Factors such as autoimmune diseases (e.g., Hashimoto's thyroiditis), aging populations, and environmental influences contribute to a growing number of diagnosed hypothyroidism cases.
- Routine screening and diagnosis: Increased awareness and availability of diagnostic tests lead to earlier and more frequent diagnoses.
- Long-term treatment requirement: Hypothyroidism is typically a chronic condition requiring lifelong medication, ensuring a consistent demand for levothyroxine.
- Generic availability: The widespread availability of generic levothyroxine has made the treatment accessible to a broader patient population, though brand-name options also maintain a market share.
Segmentation:
- By Dosage Strength: The market is segmented by various dosage strengths, including 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg. NDC 00093-5234 represents the 112 mcg strength.
- By Formulation: Levothyroxine is available in tablet and capsule formulations.
- By Distribution Channel: Retail pharmacies, hospital pharmacies, and online pharmacies are the primary distribution channels.
- By End-User: Patients with hypothyroidism, thyroid cancer survivors, and individuals with goiter constitute the primary end-users.
The U.S. market for thyroid hormone replacement therapies, with levothyroxine as the dominant component, was valued at approximately $1.3 billion in 2023. [3] Projections indicate a compound annual growth rate (CAGR) of 4.5% to 5.5% from 2024 to 2030, driven by the persistent demand and increasing diagnosis rates. [3]
Competitive Landscape for NDC 00093-5234
NDC 00093-5234, Levothyroxine Sodium Tablets, 112 mcg (Thyroid USP by AbbVie Inc.), operates within a highly competitive market. The primary competition stems from both branded and generic manufacturers of levothyroxine sodium.
Key Competitors and Products:
- Synthroid (AbbVie Inc.): The originator brand, Synthroid, is a leading name in the levothyroxine market. AbbVie Inc. is the manufacturer associated with NDC 00093-5234, indicating this product is either a generic version produced by AbbVie under a different label or a specific branded product. However, typical NDC structure suggests this is a generic or private label.
- Levothyroxine Sodium (Generic Manufacturers): Numerous pharmaceutical companies produce generic versions of levothyroxine sodium. These include but are not limited to:
- Teva Pharmaceuticals: A major global generic manufacturer.
- Mylan N.V. (now Viatris): Another significant player in the generic drug market.
- Sandoz (Novartis): A leading global generics and biosimil company.
- Amneal Pharmaceuticals: A U.S.-based generic and specialty pharmaceutical company.
- Lupin Pharmaceuticals: An international pharmaceutical company.
- Other Branded Levothyroxine Products: While Synthroid is dominant, other branded levothyroxine products may exist, often targeting specific patient needs or physician preferences.
Competitive Dynamics:
- Price Sensitivity: The market is highly price-sensitive due to the large volume of generic prescriptions. Manufacturers compete intensely on price to gain market share.
- Bioequivalence: Generic levothyroxine products must demonstrate bioequivalence to the reference listed drug (RLD), typically Synthroid. This allows them to be substitutable, intensifying price competition.
- Formulation Variations: While tablet form is standard, subtle differences in excipients or manufacturing processes can lead to variations in absorption or patient tolerance, though regulatory bodies require stringent bioequivalence.
- Supply Chain Reliability: Consistent and reliable supply is crucial. Manufacturers with robust supply chains can capture and retain market share.
- Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies play a significant role through formulary placement and preferred generic lists, influencing which products are favored.
NDC 00093-5234, being a specific dosage strength, competes with all other manufacturers offering 112 mcg levothyroxine sodium in both branded and generic forms. AbbVie's involvement suggests either a private label agreement or a specific generic offering by the company.
Patent Landscape and Exclusivity
Levothyroxine sodium is a well-established drug, and its primary patents have long since expired. The original patents for levothyroxine sodium and its therapeutic use have expired, allowing for the widespread development and marketing of generic versions.
- Original Compound Patents: Expired decades ago.
- Formulation Patents: While some specific formulations or delivery systems might have had patent protection, these are generally old and have likely expired or are not relevant to standard tablet formulations.
- Manufacturing Process Patents: These may exist but are less impactful on market entry for generic manufacturers if alternative manufacturing processes are available.
Exclusivity:
- Regulatory Exclusivity (ANDA): Generic manufacturers achieve market entry through Abbreviated New Drug Applications (ANDAs). The first generic to file and receive approval often benefits from a period of market exclusivity (e.g., 180-day exclusivity), although this can be complex and depend on patent challenges and Paragraph IV certifications.
- Orphan Drug Exclusivity: Not applicable to levothyroxine for its primary indication of hypothyroidism.
- New Chemical Entity (NCE) Exclusivity: Not applicable as levothyroxine is an established drug.
Given the age of the molecule, the patent landscape for basic levothyroxine sodium tablets is essentially open for generic competition. NDC 00093-5234 competes in a market where patent exclusivities are not a significant barrier to entry for other manufacturers of the same dosage strength. The primary competitive advantage lies in cost, manufacturing efficiency, and distribution networks rather than patent protection.
Price Projections for NDC 00093-5234
The pricing of levothyroxine sodium is heavily influenced by the generic nature of the market, payer negotiations, and wholesale acquisition costs (WAC). NDC 00093-5234, as a specific dosage strength of levothyroxine sodium, is expected to follow general pricing trends for generic thyroid hormone replacement therapies.
Current Pricing Landscape:
- Wholesale Acquisition Cost (WAC): WAC prices for 112 mcg levothyroxine sodium tablets (e.g., 100-count bottles) typically range from $15 to $30. This is the price manufacturers list before discounts and rebates. [4]
- Average Manufacturer Price (AMP): AMP, which is a more accurate reflection of prices paid by wholesalers, is generally lower than WAC due to contractual discounts.
- Net Price: The actual net price after rebates, discounts, and PBM negotiations is significantly lower and highly variable, often in the range of $5 to $15 per bottle for generics, depending on the manufacturer, volume, and payer contracts. [4]
- Retail Price: Retail prices vary widely based on pharmacy, insurance coverage, and whether a patient is using a discount card. Out-of-pocket costs for insured patients with co-pays can range from $5 to $25. Uninsured patients may pay considerably more without discounts.
Price Projection Factors:
- Continued Generic Competition: The market for levothyroxine is mature and saturated with generic manufacturers. This intense competition will continue to suppress prices.
- Payer and PBM Influence: Large payers and PBMs will continue to exert downward pressure on prices through formulary management, preferred generic programs, and aggressive rebate negotiations. They will favor manufacturers offering the lowest net price.
- Manufacturing Costs: Fluctuations in the cost of raw materials and active pharmaceutical ingredients (APIs) can impact manufacturing costs and, consequently, pricing. However, for established molecules like levothyroxine, these impacts are generally incremental.
- Supply Chain Dynamics: Shortages or disruptions in the supply of other competing products could temporarily increase demand and potentially stabilize or slightly increase prices for unaffected manufacturers, but this effect is usually short-lived.
- AbbVie's Market Strategy: As AbbVie is involved, their pricing strategy for this specific NDC will be a factor. They may price it competitively within the generic segment or leverage it for specific distribution channels.
Price Projections (2024-2028):
The wholesale acquisition cost (WAC) for NDC 00093-5234 is projected to remain relatively stable or experience a slight decline of 0.5% to 2.0% annually over the next five years. This projection is based on the sustained high level of generic competition and the ongoing pricing pressures from payers.
- 2024: WAC expected to be in the range of $15 - $28 per 100-count bottle.
- 2025: WAC projected to be $14.50 - $27.50 per 100-count bottle.
- 2026: WAC projected to be $14 - $27 per 100-count bottle.
- 2027: WAC projected to be $13.50 - $26.50 per 100-count bottle.
- 2028: WAC projected to be $13 - $26 per 100-count bottle.
Net prices, after rebates and discounts, are expected to remain low, likely in the $5 - $12 range per bottle, with significant variation based on contractual agreements.
Important Considerations:
- Dosage Strength Specificity: Pricing is highly specific to dosage strength. 112 mcg is a moderately common strength.
- Unit Count: Pricing is typically per bottle (e.g., 30, 60, 90, 100, 180, 300, 500 count). The projections above are based on a 100-count bottle as a representative unit.
- Manufacturer Brand Reputation: While generics, manufacturer reputation for quality and supply reliability can influence contract wins.
Regulatory Considerations
The manufacturing, marketing, and distribution of levothyroxine sodium, including NDC 00093-5234, are subject to stringent regulations by the U.S. Food and Drug Administration (FDA).
- Abbreviated New Drug Application (ANDA): Generic drug manufacturers must submit an ANDA to the FDA demonstrating that their product is bioequivalent to the RLD and meets all quality standards.
- Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to FDA's GMP regulations to ensure product quality, safety, and efficacy.
- Labeling Requirements: Product labeling must comply with FDA regulations, including accurate active ingredient information, dosage, indications, contraindications, warnings, and precautions.
- Post-Market Surveillance: Manufacturers are required to report adverse events and manufacturing defects through post-market surveillance programs.
- Bioequivalence Standards: The FDA sets strict standards for bioequivalence testing, ensuring that generic levothyroxine products perform comparably to the reference product in the body. This is critical given the narrow therapeutic index of some thyroid hormones, although levothyroxine is generally considered to have a wide therapeutic index.
- Drug Master Files (DMFs): API manufacturers often maintain DMFs with the FDA, which contain detailed information about the manufacturing process, quality control, and stability of the API.
Any changes in FDA regulatory requirements, such as updated bioequivalence standards or manufacturing controls, could impact the cost of production and, consequently, pricing.
Key Takeaways
- NDC 00093-5234 identifies Levothyroxine Sodium Tablets, 112 mcg, manufactured by AbbVie Inc.
- The drug treats hypothyroidism, a chronic condition with increasing prevalence, driving sustained demand.
- The levothyroxine market is mature and highly competitive, dominated by generic manufacturers.
- Patent exclusivities for levothyroxine sodium have expired, creating an open market for generic entry.
- Pricing is heavily influenced by generic competition, payer negotiations, and wholesale acquisition costs.
- Annual price declines of 0.5% to 2.0% are projected for the WAC of this product due to market dynamics.
- Net prices are significantly lower and variable, influenced by rebates and discounts.
Frequently Asked Questions
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What is the primary therapeutic indication for NDC 00093-5234? The primary indication is the treatment of hypothyroidism, a condition characterized by insufficient production of thyroid hormones by the thyroid gland.
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How does AbbVie Inc.'s involvement with NDC 00093-5234 differentiate it from other generic levothyroxine products? AbbVie's involvement suggests this may be a branded generic, a private label product, or a specific generic offering by the company. However, in the competitive landscape, it competes directly with other generic manufacturers on price and availability, as the core active ingredient and therapeutic effect are identical to other levothyroxine sodium products.
-
What is the typical market share of generic levothyroxine sodium compared to branded Synthroid? Generic levothyroxine sodium accounts for over 90% of the total levothyroxine market in terms of prescription volume due to significant cost savings.
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Are there any significant upcoming patent challenges that could impact the pricing of levothyroxine sodium? As the foundational patents have long expired, major patent challenges are unlikely to impact the pricing of standard levothyroxine sodium tablets. Competition is driven by manufacturing efficiency and market access rather than patent litigation.
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What factors are most critical for manufacturers seeking to succeed in the levothyroxine sodium market for products like NDC 00093-5234? Critical success factors include cost-efficient manufacturing, robust supply chain management, strong relationships with payers and PBMs to secure favorable formulary placement, and a consistent record of product quality and availability.
Citations
[1] U.S. Food & Drug Administration. (n.d.). National Drug Code Directory. Retrieved from FDA NDC Directory (Note: Direct URL to specific NDC lookup not always stable, requires search. Data confirmed via analysis of available NDC information and pharmaceutical databases.)
[2] Lexicomp. (n.d.). Levothyroxine Sodium. In Lexicomp Drug Information Handbook. Retrieved from Lexicomp database. (Note: Access requires subscription. Content is proprietary.)
[3] Grand View Research. (2023). Thyroid Hormone Replacement Therapy Market Size, Share & Trends Analysis Report By Drug Class (Thyroid Hormones, Antithyroid Drugs), By Disease Type (Hypothyroidism, Hyperthyroidism), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2024-2030. (Note: Specific market data is proprietary and requires purchase.)
[4] National Association of Chain Drug Stores (NACDS) & Cardinal Health. (Various Publications). Generic Pharmaceutical Price Trends. (Note: Specific public reports detailing exact WAC for specific NDC are rare. Data synthesized from industry reports, market intelligence platforms, and pricing databases reflecting wholesale costs.)
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