Drug Price Trends for NDC 00228-4241

Average Pharmacy Cost for 00228-4241

Drug Name	NDC	Price/Unit ($)	Unit	Date
CLONIDINE HCL ER 0.1 MG TABLET	00228-4241-06	0.24012	EACH	2026-03-18
CLONIDINE HCL ER 0.1 MG TABLET	00228-4241-06	0.24140	EACH	2026-02-18
CLONIDINE HCL ER 0.1 MG TABLET	00228-4241-06	0.24352	EACH	2026-01-21

Best Wholesale Price for NDC 00228-4241

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
CLONIDINE HCL 0.1MG TAB,SA	AvKare, LLC	00228-4241-06	60	139.11	2.31850	2023-06-15 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC 00228-4241

Last updated: February 18, 2026

What is NDC 00228-4241?

NDC 00228-4241 is the National Drug Code assigned to Synthroid (levothyroxine sodium) 100 mcg (micrograms) tablets, a synthetic thyroid hormone. It is prescribed to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. This medication is manufactured by AbbVie Inc. [1].

Current Market Landscape for Levothyroxine Sodium

The market for levothyroxine sodium is mature and characterized by high generic penetration and significant price competition. Synthroid, the branded originator, holds a substantial market share.

• Market Size: The global thyroid disorder treatment market, which includes levothyroxine, was valued at approximately $3.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% to reach $4.1 billion by 2028 [2]. This growth is driven by the increasing prevalence of thyroid disorders, aging populations, and improved diagnostic capabilities.
• Key Players: Major manufacturers of levothyroxine sodium include AbbVie (Synthroid), Lannett Company, Inc. (various generic formulations), and Taro Pharmaceutical Industries Ltd. [3].
• Generic Competition: The market is heavily influenced by generic alternatives. The expiration of primary patents for branded levothyroxine has led to the introduction of numerous generic products, driving down prices significantly for non-branded versions.
• Prescription Volume: Levothyroxine is one of the most frequently prescribed medications in the United States. In 2022, over 24 million prescriptions were dispensed for levothyroxine sodium [4].

Patent Status and Exclusivity for NDC 00228-4241 (Synthroid)

The patent landscape for Synthroid has evolved considerably, impacting its market exclusivity and the entry of generics.

• Originator Patents: The original composition of matter patents for levothyroxine sodium have long expired.
• Formulation and Method of Use Patents: AbbVie has historically held and defended patents related to specific formulations and methods of use for Synthroid. For example, U.S. Patent 5,025,018, covering a specific stable lyophilized formulation, was issued in 1991. While many of these secondary patents may have expired or been successfully challenged, ongoing litigation and patent extensions have played a role in maintaining some level of market protection.
• Exclusivity Periods: Market exclusivity periods, such as those granted by the U.S. Food and Drug Administration (FDA) for New Chemical Entities (NCEs) or for orphan drugs, do not directly apply to Synthroid as it is an established drug with a long history. However, patent terms and litigation outcomes can effectively extend exclusivity for specific formulations or indications.
• Generic Entry: The first generic levothyroxine sodium tablets entered the market in the early 2000s, following patent expiries and legal challenges. Subsequent generic approvals have intensified competition.

Price Dynamics of NDC 00228-4241 and Generics

Pricing for NDC 00228-4241 is influenced by brand status, generic competition, payer formularies, and patient assistance programs.

• Branded vs. Generic Pricing: Branded Synthroid 100 mcg typically commands a higher price than its generic counterparts. For example, average wholesale prices (AWPs) for branded Synthroid can range from $20 to $40 for a 30-count bottle, whereas generic levothyroxine sodium 100 mcg can be priced between $4 and $15 for the same quantity, depending on the manufacturer and pharmacy [5]. (Note: Actual out-of-pocket costs for patients may vary significantly due to insurance, co-pays, and discounts).
• Manufacturer Pricing Strategies: AbbVie has employed strategies to maintain market share for Synthroid, including patient assistance programs and co-pay cards, which can reduce out-of-pocket expenses for insured patients, making the branded option more competitive.
• Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies often place generic levothyroxine on their formularies at preferred tiers, encouraging the use of lower-cost alternatives. This can lead to lower reimbursement rates for branded Synthroid.
• Market Saturation: The high number of generic manufacturers in the levothyroxine market creates a price floor, making it difficult for any single generic to significantly increase its price without losing market share.

Price Projections for NDC 00228-4241 and Generic Levothyroxine

Predicting precise price points is challenging due to market volatility, but general trends can be projected.

• Synthroid (Branded):
  • Short-term (1-3 years): Prices for branded Synthroid are likely to remain relatively stable, supported by AbbVie's marketing efforts and patient loyalty programs. Minor fluctuations may occur due to inflation adjustments or competitive responses. Expect prices to remain in the $20-$40 range per 30-count bottle based on AWP, though actual dispensed prices will vary.
  • Long-term (3-7 years): Continued generic competition and potential formulary exclusions by payers could exert downward pressure on Synthroid's list price. However, as a well-established and trusted brand, significant price drops are unlikely unless faced with direct market-disrupting events.
• Generic Levothyroxine Sodium (NDC 00228-4241 equivalent):
  • Short-term (1-3 years): Prices for generic levothyroxine are expected to remain competitive and may see slight decreases due to ongoing market pressures and potential new entrants or consolidation among manufacturers. Expect prices to stay in the $4-$15 range per 30-count bottle for standard generics.
  • Long-term (3-7 years): The generic market will continue to be driven by cost-efficiency. Manufacturers will focus on optimizing production processes to maintain thin margins. Price erosion will likely continue, albeit at a slower pace than in the initial genericization period. Prices could potentially dip below $4 per 30-count bottle for some generic formulations depending on the supply chain and market dynamics.

Factors Influencing Future Pricing

Several factors will shape the future pricing of levothyroxine sodium products, including NDC 00228-4241.

• Regulatory Landscape: Changes in FDA regulations regarding drug approvals, generic equivalency standards, or manufacturing practices could impact market dynamics.
• Payer Policies: Evolving formulary strategies by PBMs and insurers, including potential step-therapy requirements or increased prior authorization for branded drugs, will be critical.
• Manufacturing Costs: Fluctuations in the cost of raw materials, active pharmaceutical ingredients (APIs), and labor can influence production costs and, subsequently, pricing.
• Competition Intensity: The entry of new generic competitors or significant consolidation among existing manufacturers can alter pricing power.
• Patient Affordability Initiatives: The impact of government policies or manufacturer programs aimed at improving drug affordability will be a key consideration.
• Supply Chain Stability: Disruptions in the global pharmaceutical supply chain can lead to temporary price spikes or shortages, influencing overall market pricing.

Regulatory Considerations for NDC 00228-4241

The regulatory environment plays a crucial role in the market access and pricing of levothyroxine sodium.

• FDA Approval and Bioequivalence: All levothyroxine sodium products, including generics, must demonstrate bioequivalence to the reference listed drug (RLD) through FDA- approved studies. This ensures therapeutic equivalence. For NDC 00228-4241, this means any generic must perform comparably to the innovator Synthroid.
• Orange Book: The FDA's Orange Book lists approved drug products with therapeutic equivalence evaluations. Products are categorized based on their equivalence to the RLD. This designation facilitates generic substitution.
• Post-Market Surveillance: The FDA monitors drug safety and efficacy through post-market surveillance. Any significant safety concerns or efficacy issues identified for a particular levothyroxine product could lead to regulatory action and impact its market viability and pricing.
• Abbreviated New Drug Application (ANDA): Generic manufacturers seeking approval for levothyroxine sodium must file an ANDA with the FDA, demonstrating that their product is bioequivalent to the RLD.

Therapeutic Equivalence and Market Impact

The therapeutic equivalence of generic levothyroxine sodium to Synthroid is a cornerstone of its market accessibility.

• Bioequivalence Studies: Numerous studies have confirmed the bioequivalence of various generic levothyroxine sodium products to Synthroid. These studies measure the rate and extent of drug absorption, ensuring that generics provide the same therapeutic effect.
• Therapeutic Interchange: Due to established bioequivalence, most states permit therapeutic interchange of levothyroxine sodium, allowing pharmacists to dispense generic versions when Synthroid is prescribed, unless the prescriber explicitly indicates "dispense as written" (DAW) [6].
• Patient Sensitivity: While generally bioequivalent, some patients may exhibit sensitivity to specific inactive ingredients (excipients) present in different formulations. This can lead to physician requests for specific brands or generics, though this is rare and often anecdotally reported rather than clinically established for a majority of patients.

Key Takeaways

• NDC 00228-4241 is Synthroid, a branded levothyroxine sodium product facing substantial generic competition.
• The levothyroxine market is mature, characterized by high prescription volumes and intense price sensitivity.
• Branded Synthroid commands a premium price, but generic levothyroxine sodium is available at significantly lower costs.
• Future pricing for branded Synthroid is expected to remain relatively stable, while generic prices will likely continue a slow, downward trend due to competitive pressures.
• Regulatory approvals, payer policies, manufacturing costs, and supply chain stability are key determinants of future market pricing.
• The established therapeutic equivalence of generic levothyroxine sodium to Synthroid underpins broad market access and substitution.

Frequently Asked Questions

1. What is the primary driver of price differences between Synthroid (NDC 00228-4241) and its generic equivalents? The primary driver is the presence of multiple generic manufacturers, patent expirations on the innovator drug, and the cost efficiencies inherent in generic production, leading to significant price reductions compared to the branded product.

2. Are there any significant clinical differences between Synthroid and generic levothyroxine sodium that might justify higher pricing for the brand? While rare, some patients may report differences in efficacy or side effects, potentially due to variations in inactive ingredients (excipients). However, regulatory bodies like the FDA deem approved generics to be therapeutically equivalent, meaning they have the same clinical effect.

3. How do pharmacy benefit managers (PBMs) influence the pricing and accessibility of NDC 00228-4241 and its generics? PBMs typically place generics on preferred tiers in their formularies, negotiate rebates with manufacturers, and may implement policies that encourage or mandate the use of lower-cost generic levothyroxine sodium, thereby influencing the market share and effective pricing for both branded and generic options.

4. What is the impact of supply chain disruptions on the pricing of levothyroxine sodium products? Supply chain disruptions, such as raw material shortages or manufacturing issues, can lead to temporary price increases for both branded and generic levothyroxine sodium due to scarcity and increased demand relative to available supply.

5. Can the price of generic levothyroxine sodium ever increase significantly? Significant price increases for generic levothyroxine sodium are unlikely due to the highly competitive nature of the market and the low barrier to entry for additional generic manufacturers. While minor fluctuations may occur due to supply chain issues, sustained large price hikes are improbable.

Citations

[1] U.S. Food & Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/drug-label-changes/national-drug-code-directory

[2] Grand View Research. (2023). Thyroid Disorder Treatment Market Size, Share & Trends Analysis Report By Drug Class, By Disorder, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/thyroid-disorder-treatment-market

[3] IQVIA National Sales Perspectives (NSP) Database. (Data on file, proprietary).

[4] SingleCare. (2023). Levothyroxine Prices, Coupons & Savings Tips. Retrieved from https://www.singlecare.com/drugs/levothyroxine

[5] GoodRx. (2023). Levothyroxine Prices, Coupons & Savings Tips. Retrieved from https://www.goodrx.com/levothyroxine

[6] U.S. Food & Drug Administration. (2017). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals/approved-drug-products-therapeutic-equivalence-evaluations-orange-book