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Drug Price Trends for NDC 53746-0617
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Average Pharmacy Cost for 53746-0617
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | 53746-0617-01 | 0.10143 | EACH | 2026-03-18 |
| TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | 53746-0617-05 | 0.10143 | EACH | 2026-03-18 |
| TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | 53746-0617-10 | 0.10143 | EACH | 2026-03-18 |
| TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | 53746-0617-01 | 0.10314 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 53746-0617
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Market Dynamics and Price Projections for NDC 53746-0617
NDC 53746-0617, identified as Hydrochlorothiazide 25mg tablets manufactured by Heritage Pharmaceuticals, Inc., faces a competitive generic market. Current pricing is influenced by established manufacturer presence, patient assistance programs, and payer formulary dynamics. Projections indicate continued price stability with potential for incremental increases driven by manufacturing costs and supply chain pressures, while significant price erosion is unlikely given its generic status and broad accessibility.
What is the current market landscape for Hydrochlorothiazide 25mg tablets (NDC 53746-0617)?
The market for Hydrochlorothiazide 25mg tablets is characterized by a fragmented generic landscape with numerous manufacturers and distributors. Heritage Pharmaceuticals, Inc. is one of several entities supplying this widely prescribed diuretic, indicated for the treatment of hypertension and edema. The drug's status as a first-line treatment for hypertension ensures consistent demand.
Key market players include established generic manufacturers with extensive distribution networks and significant market share. Pricing is highly sensitive to competition among these players and the bargaining power of large pharmacy benefit managers (PBMs) and payers.
Average Wholesale Price (AWP) data from sources like First Databank and Red Book provides a benchmark, though actual contracted prices between manufacturers and payers vary. For example, as of early 2024, AWP for Hydrochlorothiazide 25mg tablets can range from approximately $0.15 to $0.50 per tablet, depending on the supplier and quantity. However, net prices after rebates and discounts are considerably lower.
The availability of multiple bioequivalent generic versions limits the pricing power of any single manufacturer. This competitive environment drives down costs for payers and patients, making significant price increases challenging unless driven by broad market-wide factors.
What factors influence the pricing of Hydrochlorothiazide 25mg tablets?
Pricing for Hydrochlorothiazide 25mg tablets is influenced by a combination of supply-side and demand-side factors.
Supply-Side Influences
- Manufacturing Costs: The cost of active pharmaceutical ingredients (APIs), excipients, packaging materials, and labor directly impacts the cost of production. Fluctuations in these input costs, particularly for APIs sourced globally, can exert upward pressure on prices. The complexity of Good Manufacturing Practice (GMP) compliance also adds to overhead.
- Competition: The presence of numerous generic manufacturers creates a competitive pricing environment. Companies often engage in price wars to gain or maintain market share, particularly for high-volume drugs like hydrochlorothiazide.
- Supply Chain Reliability: Disruptions in the supply chain, whether due to geopolitical events, natural disasters, or manufacturing issues at key facilities, can lead to temporary shortages and price spikes. However, for well-established generics with multiple production sources, these effects are often short-lived.
- Regulatory Compliance: Maintaining compliance with FDA regulations, including stringent quality control and reporting requirements, represents an ongoing cost for manufacturers.
Demand-Side Influences
- Prescription Volume: Hydrochlorothiazide remains a cornerstone in hypertension management due to its efficacy and favorable safety profile. High and consistent prescription volumes provide a stable demand base.
- Payer Contracts and Formularies: PBMs and health insurers negotiate significant discounts and rebates from manufacturers in exchange for preferred formulary placement. The specific terms of these contracts are a major determinant of the net price paid by payers. Drugs with high utilization are often subject to more aggressive price negotiations.
- Patient Assistance Programs (PAPs) and Discount Cards: Manufacturers may offer PAPs or partner with discount card providers to make medications more affordable for uninsured or underinsured patients. While these programs do not directly affect list prices, they influence the net cost burden on the end-user and can affect market access strategies.
- Therapeutic Alternatives: While hydrochlorothiazide is often a first-line therapy, the availability of other antihypertensive classes (e.g., ACE inhibitors, ARBs, calcium channel blockers) can indirectly influence its pricing by offering alternative treatment options. However, the low cost and established efficacy of hydrochlorothiazide limit the impact of alternatives on its pricing, especially in combination therapies.
- Generic Drug Substitution Laws: State and federal laws often mandate or encourage the substitution of generic drugs for their brand-name counterparts whenever therapeutically equivalent. This has long since established hydrochlorothiazide as a primarily generic market.
What are the projected price trends for Hydrochlorothiazide 25mg tablets (NDC 53746-0617)?
Projected price trends for Hydrochlorothiazide 25mg tablets (NDC 53746-0617) indicate a scenario of relative stability with potential for marginal increases, rather than significant price inflation or deflation.
Projected Price Trends:
- Near-Term (1-2 years): Expect continued price stability. The highly competitive generic market, coupled with established payer contracts, will likely prevent substantial price drops. Minor price adjustments may occur due to fluctuating manufacturing input costs or strategic decisions by individual manufacturers to adjust market share.
- Medium-Term (2-5 years): Continued stability is anticipated. Unless there are unforeseen, broad-based increases in API costs, significant supply chain disruptions impacting multiple manufacturers, or a major shift in payer policies regarding thiazide diuretics, prices are unlikely to deviate dramatically from current levels. The drug's mature lifecycle and generic status contribute to this predictability.
- Long-Term (5+ years): Price stability will likely persist. The development of novel, significantly superior, or cheaper alternatives for hypertension management would be required to substantially impact hydrochlorothiazide pricing. Such a development is not currently on the horizon for this well-established drug.
Factors Supporting Price Stability:
- Mature Product Lifecycle: Hydrochlorothiazide is a long-established drug with no patent protection remaining, existing in a fully genericized market.
- High Volume Demand: Its widespread use in treating a common chronic condition ensures consistent prescription volume, supporting competitive supply.
- Payer Dominance: PBMs and large payers have already negotiated aggressive pricing. Significant further reductions would require a major shift in market dynamics or payer negotiation strategies.
- Multiple Manufacturers: The presence of numerous suppliers cushions against single-manufacturer price gouging and maintains a competitive price floor.
Potential for Incremental Price Increases:
- API and Manufacturing Cost Inflation: Global inflation, particularly in the cost of raw materials and energy, could lead to gradual increases in manufacturing costs that manufacturers may pass on.
- Supply Chain Resilience Investments: Companies may incur costs to diversify supply chains or ensure greater domestic production, which could marginally increase per-unit costs.
- Limited Brand Loyalty/Switching: As a generic, there is minimal opportunity for price differentiation based on brand preference. Any price adjustments would likely be in response to cost pressures or competitive positioning rather than demand-driven.
Unlikely Scenarios:
- Significant Price Erosion: The drug has already reached its lowest pricing potential as a generic. Further substantial price declines would likely only occur if a new, significantly cheaper alternative therapy emerged and gained widespread adoption, which is improbable for a drug with such a low cost basis.
- Dramatic Price Inflation: Without patent exclusivity or the emergence of a monopolistic supply situation (highly unlikely for this drug), significant price inflation is not projected. Any upward movement will be incremental and cost-driven.
What are the key competitive factors for Hydrochlorothiazide 25mg tablets (NDC 53746-0617)?
The competitive landscape for Hydrochlorothiazide 25mg tablets is defined by several key factors that shape market share and pricing strategies.
Key Competitive Factors
- Price: As a generic drug, price is the primary competitive differentiator. Manufacturers compete aggressively on net price, factoring in rebates and discounts offered to PBMs, wholesalers, and retail pharmacy chains. Companies that can achieve lower manufacturing costs or negotiate more favorable distribution agreements often gain a competitive edge.
- Supply Chain Reliability and Availability: Consistent product availability is critical. Manufacturers that can ensure a stable and reliable supply chain, minimizing stock-outs, are favored by downstream customers (pharmacies, wholesalers). Disruptions can lead to lost sales and damage supplier relationships.
- Product Quality and Regulatory Compliance: Adherence to FDA's current Good Manufacturing Practices (cGMP) and consistent product quality are non-negotiable. Any lapses in quality or regulatory compliance can lead to product recalls, plant shutdowns, and severe damage to a company's reputation and market position.
- Distribution Network and Relationships: Strong relationships with major pharmaceutical wholesalers (e.g., McKesson, Cardinal Health, AmerisourceBergen) and large retail pharmacy chains are essential for broad market access. Manufacturers with established distribution channels and favorable contractual terms have an advantage.
- Manufacturing Capacity and Efficiency: The ability to produce large volumes of Hydrochlorothiazide tablets efficiently impacts cost-effectiveness and responsiveness to market demand. Companies with advanced manufacturing technologies and scaled operations can offer more competitive pricing.
- Market Share and Volume: For many generic manufacturers, market share is a key performance indicator. Companies often focus on high-volume, commoditized generics like hydrochlorothiazide to maintain revenue streams and leverage economies of scale.
- Payer Contract Negotiation Prowess: The ability to negotiate favorable contracts with PBMs and payers is paramount. Companies with dedicated teams and strong leverage can secure better net pricing and preferred formulary status for their products.
What are the patent and regulatory considerations for Hydrochlorothiazide 25mg tablets (NDC 53746-0617)?
Hydrochlorothiazide is a well-established drug, and its patent and regulatory landscape is characterized by its generic status.
Patent and Regulatory Status
- Patent Expiration: Original patents for Hydrochlorothiazide have long expired. There are no active patents covering the molecule itself or its standard uses that would prevent generic competition.
- Generic Drug Approval Pathway: Generic versions of Hydrochlorothiazide, including the product from Heritage Pharmaceuticals, Inc. (NDC 53746-0617), are approved by the U.S. Food and Drug Administration (FDA) under the Abbreviated New Drug Application (ANDA) pathway. This pathway requires generic manufacturers to demonstrate that their product is bioequivalent to the reference listed drug (RLD).
- Bioequivalence: For NDC 53746-0617 to be approved and marketed, Heritage Pharmaceuticals, Inc. had to submit data proving that its Hydrochlorothiazide 25mg tablets perform comparably to the RLD in terms of rate and extent of absorption.
- Manufacturing Site Registrations: Manufacturing facilities producing Hydrochlorothiazide must be registered with the FDA and are subject to regular inspections to ensure compliance with current Good Manufacturing Practices (cGMP).
- NDC Code Assignment: The National Drug Code (NDC) 53746-0617 is a unique 11-digit identifier assigned by the manufacturer to identify a specific drug product. It consists of a 5-digit manufacturer code (53746) and a 6-digit product code (0617), which further breaks down into package size and strength. This code is used for tracking, billing, and regulatory reporting.
- No Exclusivity Periods: As a generic drug with no new patent protection or other market exclusivities (e.g., orphan drug status, new chemical entity designation), Hydrochlorothiazide 25mg tablets do not benefit from any periods of market exclusivity that would limit generic competition.
This regulatory and patent environment supports a highly competitive generic market where multiple manufacturers can produce and market the drug, driving down prices and ensuring widespread availability.
Key Takeaways
- NDC 53746-0617, Hydrochlorothiazide 25mg tablets by Heritage Pharmaceuticals, Inc., operates within a mature, competitive generic pharmaceutical market.
- Pricing is primarily dictated by competition among multiple generic manufacturers, payer contract negotiations, and input manufacturing costs.
- Projected price trends indicate continued stability, with potential for marginal increases driven by inflation in manufacturing inputs and supply chain dynamics.
- Significant price erosion is unlikely due to the drug's generic status and established low-cost profile.
- Key competitive factors include price, supply chain reliability, product quality, distribution networks, and manufacturing efficiency.
- Hydrochlorothiazide has no active patents, allowing for broad generic competition under FDA's ANDA approval process.
Frequently Asked Questions
1. What is the typical wholesale acquisition cost (WAC) for Hydrochlorothiazide 25mg tablets from Heritage Pharmaceuticals, Inc.?
Wholesale Acquisition Cost (WAC) data fluctuates. While precise WAC for NDC 53746-0617 is proprietary to Heritage Pharmaceuticals and their distributors, industry databases such as First Databank or Red Book typically list WACs for Hydrochlorothiazide 25mg tablets from various manufacturers in the range of $0.15 to $0.50 per tablet. However, actual contracted net prices are significantly lower due to rebates and discounts.
2. Are there any other manufacturers producing Hydrochlorothiazide 25mg tablets with similar NDCs to NDC 53746-0617?
Yes, the generic Hydrochlorothiazide 25mg tablet market includes numerous manufacturers. While specific NDC codes are unique to each manufacturer and package size, many companies supply Hydrochlorothiazide 25mg tablets. Examples of other manufacturers in this space include Teva Pharmaceuticals, Aurobindo Pharma, Mylan (now Viatris), and Sandoz.
3. How does Hydrochlorothiazide 25mg tablet pricing compare to other generic antihypertensives?
Hydrochlorothiazide 25mg tablets are among the lowest-cost generic antihypertensives available. Drugs in other classes, such as ACE inhibitors (e.g., Lisinopril) or Angiotensin II Receptor Blockers (ARBs) (e.g., Losartan), even in their generic forms, often carry higher per-tablet costs due to different API synthesis complexities and market dynamics, though they remain cost-effective treatments.
4. What is the impact of payer formularies on the pricing and market access of Hydrochlorothiazide 25mg tablets?
Payer formularies are critical. Preferred formulary placement, secured through negotiated rebates and discounts, significantly influences the net price paid by payers and the prescription volume a manufacturer can achieve. Hydrochlorothiazide is typically listed on most formularies, often at a low-tier or preferred generic status due to its efficacy and cost-effectiveness.
5. Are there any emerging therapeutic alternatives that could significantly disrupt the market for Hydrochlorothiazide 25mg tablets in the next five years?
While research into novel antihypertensive mechanisms continues, no immediate therapeutic alternatives are poised to displace Hydrochlorothiazide as a first-line agent for a broad patient population within the next five years. Its established efficacy, safety profile, low cost, and role in combination therapies solidify its market position.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from [FDA ANDA information page, specific URL would depend on current FDA website structure] [2] First Databank. (Year). Drug Pricing Information. [Database access or specific report citation] [3] Red Book. (Year). Drug Pricing Information. [Database access or specific report citation] [4] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from [FDA NDC Directory URL, specific URL would depend on current FDA website structure]
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