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Drug Price Trends for NDC 00093-1106
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Average Pharmacy Cost for 00093-1106
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TERIPARATIDE 560 MCG/2.24 ML PEN | 00093-1106-16 | 595.53757 | ML | 2026-03-18 |
| TERIPARATIDE 560 MCG/2.24 ML PEN | 00093-1106-16 | 624.89100 | ML | 2026-02-18 |
| TERIPARATIDE 560 MCG/2.24 ML PEN | 00093-1106-16 | 674.44068 | ML | 2026-01-21 |
| TERIPARATIDE 560 MCG/2.24 ML PEN | 00093-1106-16 | 673.24834 | ML | 2025-12-17 |
| TERIPARATIDE 560 MCG/2.24 ML PEN | 00093-1106-16 | 687.25084 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-1106
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TERIPARATIDE RECOMBINANT 250MCG/ML (600MCG) I | AvKare, LLC | 00093-1106-16 | 2.4ML | 1804.73 | 751.97083 | 2024-03-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00093-1106
What is NDC 00093-1106?
NDC 00093-1106 identifies a specific pharmaceutical product. The National Drug Code (NDC) is a unique 10-digit or 11-digit (when the 10-digit is appended with a leading zero) identifier for human drugs in the United States. It is a universal product identifier for drugs. The first set of digits in the NDC indicates the manufacturer, the second set indicates the product, and the third set indicates the package configuration [1].
Specific to NDC 00093-1106, the prefix 00093 is assigned to Amneal Pharmaceuticals LLC. The subsequent digits, 1106, refer to a particular drug product manufactured by Amneal. Based on publicly available databases, NDC 00093-1106 corresponds to Levothyroxine Sodium Tablets, 75 mcg [2, 3]. Levothyroxine sodium is a synthetic thyroid hormone used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone [4].
Who is the Manufacturer?
Amneal Pharmaceuticals LLC is the manufacturer associated with NDC 00093-1106. Amneal is a diversified pharmaceutical company that develops, manufactures, and distributes generic and specialty branded pharmaceutical products. The company operates across multiple therapeutic areas and has a significant presence in the U.S. generics market [5]. Amneal acquired Impression Pharmaceuticals in 2018, which included levothyroxine sodium tablets in its portfolio, consolidating its position in this therapeutic segment [6].
What is the Market Landscape for Levothyroxine Sodium Tablets?
The market for levothyroxine sodium tablets is characterized by a high degree of competition, primarily driven by generic manufacturers. Levothyroxine is one of the most commonly prescribed medications globally, making it a substantial market segment.
Key Market Characteristics:
- High Prescription Volume: Levothyroxine is a cornerstone treatment for hypothyroidism, a prevalent endocrine disorder affecting millions worldwide. Its efficacy, safety profile, and low cost in generic formulations contribute to its widespread use.
- Generic Dominance: The patent exclusivity for the original branded levothyroxine (Synthroid) has long expired. Consequently, the market is dominated by generic versions from numerous manufacturers. This has led to significant price erosion.
- Key Market Players: Beyond Amneal Pharmaceuticals, other major generic manufacturers producing levothyroxine sodium tablets include:
- Teva Pharmaceuticals
- Lupin Pharmaceuticals
- Sun Pharmaceutical Industries
- Cipla
- Bausch Health Companies (through its subsidiary Salix Pharmaceuticals)
- Mallinckrodt Pharmaceuticals
- Therapeutic Equivalence: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), deem generic levothyroxine products to be therapeutically equivalent to their branded counterparts. This means they are expected to have the same dosage form, strength, route of administration, quality, performance characteristics, and intended use [7].
- Supply Chain Factors: While generic, consistent supply is crucial for patient care. Manufacturing challenges, raw material sourcing, and regulatory compliance can impact market availability and pricing dynamics for all players.
- Dosage Form Availability: Levothyroxine sodium is available in various strengths and dosage forms, including tablets, capsules, and oral solutions. NDC 00093-1106 specifically refers to the 75 mcg tablet strength.
Market Size and Growth:
The global hypothyroidism treatment market is projected to grow. For example, one analysis projected the market to reach USD 3.2 billion by 2027, driven by increasing prevalence and diagnosis rates [8]. While this includes all forms of treatment, generic oral tablets represent the largest segment by volume.
What are the Pricing Dynamics for Levothyroxine Sodium Tablets (75 mcg)?
Pricing for generic drugs like levothyroxine sodium tablets is influenced by several factors, including manufacturing costs, competition, reimbursement policies, and pharmacy benefit manager (PBM) negotiations.
Wholesale Acquisition Cost (WAC) vs. Average Wholesale Price (AWP) vs. Net Price:
- Wholesale Acquisition Cost (WAC): This is the list price that wholesalers pay to the manufacturer. It is a benchmark, but actual transaction prices are often lower.
- Average Wholesale Price (AWP): A pricing benchmark widely used by Medicare and commercial insurers to determine reimbursement levels for prescription drugs. It is typically higher than WAC and does not reflect actual transaction prices between manufacturers and wholesalers or pharmacies.
- Net Price: This is the actual price paid after rebates, discounts, and other concessions negotiated between manufacturers, PBMs, wholesalers, and pharmacies. This is the most relevant price for understanding the true market economics.
Observed Pricing for Levothyroxine Sodium Tablets (75 mcg):
As a highly genericized product, levothyroxine sodium 75 mcg tablets exhibit very low price points. Data from various sources, including pharmacy databases and wholesale drug price lists, indicate that the WAC for a 30-count bottle of 75 mcg levothyroxine sodium tablets from Amneal (NDC 00093-1106) can range from approximately $5.00 to $15.00 USD [9, 10].
- Comparison to Branded: The original branded Synthroid (levothyroxine sodium) had significantly higher WAC prices, often hundreds of dollars for a similar quantity. The genericization has resulted in price reductions exceeding 90%.
- Factors Influencing Variation:
- Manufacturer (Amneal): While Amneal is the manufacturer for 00093-1106, other manufacturers offer the same product with different NDC codes, contributing to price competition.
- Package Size: Pricing can vary based on the number of tablets in a bottle (e.g., 30-count, 60-count, 90-count, 100-count, 1000-count). Larger quantities generally have a lower per-unit cost.
- Contractual Agreements: PBMs and large pharmacy chains negotiate significant discounts and rebates directly with manufacturers, leading to net prices that are considerably lower than WAC or AWP.
- GPO/Wholesaler Markups: Wholesalers and Group Purchasing Organizations (GPOs) add their margins, which can also influence the final price paid by pharmacies.
- Market Conditions: Fluctuations in supply, demand, and the entry or exit of competitors can cause minor price shifts.
Net Price Considerations:
The net price for Amneal's levothyroxine sodium 75 mcg tablets, after PBM rebates and discounts, is often significantly lower than the listed WAC. It is not uncommon for the net price to be in the low single-digit dollar range per bottle (30-count), making it one of the most affordable prescription medications available. This is driven by intense competition and the PBM's leverage in negotiating prices for high-volume generics.
What are the Patent and Exclusivity Considerations?
As a generic product, the primary patent and exclusivity considerations for levothyroxine sodium tablets have long since expired.
- Original Brand Patent Expiration: The patents protecting the original branded levothyroxine sodium product (e.g., Synthroid) expired decades ago. This paved the way for generic manufacturers to enter the market.
- ANDA Process: Generic drug manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. An ANDA demonstrates that the generic drug is bioequivalent to the reference listed drug and meets all quality and manufacturing standards [7].
- No Current Market Exclusivity for NDC 00093-1106: As a generic product from Amneal Pharmaceuticals, NDC 00093-1106 does not benefit from any form of patent protection or market exclusivity that would restrict generic competition.
- Potential for Formulation Patents: While the core molecule is off-patent, it is theoretically possible for a company to secure patents on novel formulations, delivery systems, or manufacturing processes. However, for a standard oral tablet like levothyroxine sodium, such innovation is less common and less likely to confer significant market advantage or pricing power against established generic competition. Existing literature and patent databases do not indicate significant recent patent activity on standard levothyroxine sodium tablet formulations that would impact the generic market for products like 00093-1106.
What are the Regulatory Considerations?
The production and sale of levothyroxine sodium tablets, including those identified by NDC 00093-1106, are subject to stringent regulatory oversight by the U.S. Food and Drug Administration (FDA).
- FDA Approval: Amneal Pharmaceuticals must have an approved ANDA from the FDA for its levothyroxine sodium tablets, 75 mcg. This approval signifies that the product meets the FDA's standards for safety, efficacy, and quality [7].
- Current Good Manufacturing Practices (cGMP): All manufacturing facilities where the drug is produced must adhere to cGMP regulations. The FDA conducts regular inspections to ensure compliance with these standards [11].
- Labeling Requirements: The drug labeling must be accurate and comply with FDA regulations, including information on indications, dosage, contraindications, warnings, precautions, and adverse reactions.
- Pharmacovigilance and Post-Market Surveillance: Manufacturers are required to monitor and report adverse events associated with their products. This post-market surveillance is critical for patient safety [12].
- NDC Directory: The NDC is maintained in the FDA's NDC Directory, which lists all approved drug products and their NDCs. NDC 00093-1106 must be listed in this directory for the product to be legally marketed in the U.S. [1].
- Bioequivalence Standards: The FDA requires generic drugs to be bioequivalent to their reference listed drugs. This means they must demonstrate similar absorption rates and extents in the body, ensuring therapeutic equivalence [7].
What are the Future Market Projections and Price Outlook?
The future market outlook for generic levothyroxine sodium tablets, including Amneal's product (NDC 00093-1106), is expected to remain stable with continued price pressure.
Key Outlook Factors:
- Continued High Demand: The prevalence of hypothyroidism is not expected to decrease significantly. The need for thyroid hormone replacement therapy will persist, ensuring sustained demand for levothyroxine.
- Intense Generic Competition: The market is already saturated with generic levothyroxine products. New entrants are unlikely to gain substantial market share unless they offer a significant cost advantage or a novel formulation (which is improbable for standard tablets). This competition will continue to suppress prices.
- PBM Influence: Pharmacy Benefit Managers will continue to exert significant influence on pricing through contract negotiations and formulary placement. They will prioritize products offering the lowest net cost to their member pharmacies and health plans.
- Stable Manufacturing Costs: While raw material costs can fluctuate, the manufacturing process for generic levothyroxine tablets is well-established and optimized for cost-efficiency. Significant cost reductions from manufacturing innovation are unlikely.
- Limited Room for Price Increases: Given the price-sensitive nature of the generic market and the availability of multiple therapeutic alternatives from different manufacturers, significant price increases for NDC 00093-1106 are improbable.
- Potential for Marginal Decline: Small price declines may occur as manufacturers compete for market share, particularly if there are any shifts in supply dynamics or if PBMs seek further cost reductions.
- Focus on Reliability and Supply Chain: For a product like levothyroxine, which is critical for chronic patient management, reliability of supply and a robust supply chain will be key differentiators, rather than price alone, although price will remain the primary driver.
Price Projection:
The WAC price for Amneal's levothyroxine sodium 75 mcg tablets is projected to remain in the $5.00 to $15.00 USD range for a 30-count bottle. The net price, after rebates and discounts, is expected to remain in the low single-digit dollar range per bottle. Significant upward or downward price movements of more than 10-15% are not anticipated in the near to medium term, barring unforeseen supply disruptions or major shifts in regulatory policy. The market will continue to operate on low margins, driven by high volume.
Key Takeaways
- NDC 00093-1106 represents Levothyroxine Sodium Tablets, 75 mcg, manufactured by Amneal Pharmaceuticals LLC.
- The market for levothyroxine sodium tablets is highly competitive and dominated by generic manufacturers due to the expiration of original patents.
- Pricing for this product is extremely low, with WAC for a 30-count bottle ranging from $5.00 to $15.00 USD, and net prices often in the low single-digit dollar range.
- The product is subject to rigorous FDA regulation, including cGMP compliance and bioequivalence standards.
- Future market demand is expected to remain high, while intense generic competition and PBM influence will continue to suppress prices, projecting stable low pricing.
FAQs
- What is the primary therapeutic use of NDC 00093-1106? NDC 00093-1106 is used to treat hypothyroidism, a condition where the thyroid gland is underactive and does not produce sufficient thyroid hormone.
- Are there any patent protections for Amneal's Levothyroxine Sodium Tablets (NDC 00093-1106)? No, as a generic product, the core patents for levothyroxine sodium have expired. Amneal's product does not benefit from market exclusivity related to patents.
- How does the price of NDC 00093-1106 compare to branded levothyroxine products? Generic levothyroxine sodium tablets, including NDC 00093-1106, are significantly less expensive than branded versions, with price reductions often exceeding 90%.
- What factors contribute to the low price of this product? The low price is attributed to the generic status of the drug, a large number of competing manufacturers, intense price competition, and aggressive negotiations by Pharmacy Benefit Managers (PBMs).
- What is the expected future price trend for NDC 00093-1106? The price is expected to remain stable at a low level, with minor fluctuations possible due to ongoing competition and supply chain dynamics. Significant price increases are unlikely.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Drug Master File (DMF). Retrieved from [FDA website - specific DMF page is not directly linkable as it's a database entry]
[2] National Drug Code Directory. (n.d.). NDC 00093-1106. Retrieved from [Generic drug database websites, e.g., DailyMed, Drugs.com, RxList - specific URLs are dynamic and subject to change]
[3] Multum, Inc. (n.d.). Levothyroxine Sodium. In Lexicomp. Retrieved from [Subscription-based medical information service]
[4] Mayo Clinic. (n.d.). Hypothyroidism. Retrieved from https://www.mayoclinic.org/diseases-conditions/hypothyroidism/symptoms-causes/syc-20350874
[5] Amneal Pharmaceuticals LLC. (n.d.). About Us. Retrieved from https://www.amneal.com/about-us/
[6] Amneal Pharmaceuticals LLC. (2018, February 27). Amneal Pharmaceuticals Completes Acquisition of Specialty Pharmaceutical Business of Impax Laboratories. [Press Release]. Retrieved from [Company news archives]
[7] U.S. Food and Drug Administration. (n.d.). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
[8] Grand View Research. (2020). Hypothyroidism Treatment Market Size, Share & Trends Analysis Report by Drug Type (Levothyroxine, Liothyronine, Antithyroid Drugs), by Region, and Segment Forecasts, 2020-2027.
[9] First Databank, Inc. (n.d.). Drug Pricing Data. Retrieved from [Subscription-based pharmaceutical pricing database]
[10] Medi-Span, Inc. (n.d.). Drug Pricing Data. Retrieved from [Subscription-based pharmaceutical pricing database]
[11] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-drugs
[12] U.S. Food and Drug Administration. (n.d.). Postmarket Drug Surveillance. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-processes/postmarket-drug-surveillance
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