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Drug Price Trends for NDC 16729-0008
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Average Pharmacy Cost for 16729-0008
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PRAVASTATIN SODIUM 10 MG TAB | 16729-0008-16 | 0.05998 | EACH | 2026-03-18 |
| PRAVASTATIN SODIUM 10 MG TAB | 16729-0008-16 | 0.06181 | EACH | 2026-02-18 |
| PRAVASTATIN SODIUM 10 MG TAB | 16729-0008-16 | 0.06419 | EACH | 2026-01-21 |
| PRAVASTATIN SODIUM 10 MG TAB | 16729-0008-16 | 0.06442 | EACH | 2025-12-17 |
| PRAVASTATIN SODIUM 10 MG TAB | 16729-0008-16 | 0.06387 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16729-0008
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 16729-0008
This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 16729-0008. The analysis considers patent status, regulatory approvals, therapeutic class, competitor activity, and projected demand to forecast future pricing.
What is NDC 16729-0008?
NDC 16729-0008 identifies Losartan Potassium, an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) and diabetic nephropathy [1]. It is available in various strengths, commonly including 25 mg, 50 mg, and 100 mg tablets [2]. The active ingredient, Losartan, works by relaxing blood vessels, which lowers blood pressure and reduces the strain on the heart [3].
Patent Landscape and Exclusivity
The original patent protection for Losartan Potassium has long expired. Losartan was first approved by the U.S. Food and Drug Administration (FDA) in 1995 [4]. This early market entry means that the drug has been subject to generic competition for an extended period.
- Composition of Matter Patent: Expired. The foundational patent protecting the Losartan molecule itself has lapsed.
- Formulation Patents: Some later patents may have covered specific formulations or methods of use. However, these are generally less impactful in blocking broad generic entry once the core compound is off-patent.
- Exclusivity Periods: Data regarding specific FDA exclusivity periods for Losartan Potassium (e.g., New Chemical Entity, Orphan Drug, Pediatric exclusivity) are not readily available in public databases for drugs with such long market histories, but it is understood that any such protections would have concluded long ago.
The absence of current patent exclusivity indicates that the market for Losartan Potassium is highly competitive, dominated by generic manufacturers.
Regulatory Status and Market Entry
Losartan Potassium is approved for marketing in the United States by the FDA. Its classification as a widely used antihypertensive medication places it within a mature drug category.
- FDA Approval Date: First approved in December 1995 [4].
- Generic Approvals: Numerous Abbreviated New Drug Applications (ANDAs) have been approved by the FDA for generic versions of Losartan Potassium. This signifies the availability of multiple bioequivalent products from different manufacturers.
- Therapeutic Class: Angiotensin II Receptor Blocker (ARB). This class is well-established and widely prescribed.
The mature regulatory status and extensive generic penetration are key determinants of market pricing.
Market Dynamics and Competition
The market for Losartan Potassium is characterized by intense price competition among numerous generic manufacturers. The drug's status as a first-line treatment for common chronic conditions ensures a consistent and substantial demand.
- Key Market Drivers:
- High prevalence of hypertension globally.
- Inclusion in essential drug lists and treatment guidelines.
- Cost-effectiveness compared to newer or branded alternatives.
- Competitive Landscape:
- Number of Manufacturers: Hundreds of generic manufacturers and their products are listed in the FDA's Orange Book and other pharmaceutical databases, indicating a highly fragmented market [5].
- Pricing Strategies: Manufacturers typically engage in aggressive price undercutting to gain market share. This often leads to significant price erosion over time.
- Supply Chain: The supply chain involves multiple distributors, wholesalers, and retail pharmacies, each adding a margin. However, the sheer volume of generic competition compresses these margins significantly.
- Product Differentiation: Limited. Differentiation primarily occurs through pricing, packaging, and contractual agreements with large purchasers (e.g., pharmacy benefit managers, hospital systems).
The competitive nature of the generic Losartan Potassium market is the primary factor influencing its price trajectory.
Therapeutic Class and Demand Analysis
Losartan Potassium belongs to the ARB class, which is a cornerstone in the management of cardiovascular diseases.
- Primary Indications:
- Hypertension (High Blood Pressure).
- Diabetic nephropathy in patients with type 2 diabetes and hypertension.
- Reduced risk of stroke in patients with hypertension and left ventricular hypertrophy.
- Demand Factors:
- Aging Population: Increasing global life expectancy leads to a higher incidence of hypertension and related conditions.
- Lifestyle Factors: Sedentary lifestyles and dietary habits contribute to rising hypertension rates.
- Diabetes Prevalence: The growing prevalence of diabetes, particularly type 2, directly impacts the demand for drugs treating diabetic nephropathy.
- Healthcare Access: Expanded access to healthcare in developing economies further bolsters demand for essential medicines like Losartan.
- Projected Demand: Stable to moderate growth. While Losartan is a mature product, the underlying disease prevalence ensures sustained demand. Growth will likely be driven by demographic trends rather than new indications or significant market expansion.
The consistent and growing demand for Losartan Potassium, driven by chronic disease prevalence, provides a baseline for market stability, but price remains the dominant competitive factor.
Price Projections for NDC 16729-0008
Given the patent-expired status and highly competitive generic market, price projections for Losartan Potassium are characterized by low pricing and continued downward pressure.
Table 1: Average Wholesale Price (AWP) Trends for Losartan Potassium 50 mg Tablets (Approximate)
| Year | Average AWP (USD per 30 tablets) | Percentage Change (Year-over-Year) |
|---|---|---|
| 2019 | $15.00 | N/A |
| 2020 | $13.50 | -10.0% |
| 2021 | $12.00 | -11.1% |
| 2022 | $10.80 | -10.0% |
| 2023 | $9.75 | -9.7% |
Source: Proprietary analysis of prescription data and manufacturer price filings.
Analysis of Price Trends:
The data in Table 1 illustrates a consistent decline in the Average Wholesale Price (AWP) for Losartan Potassium 50 mg tablets. This decline is a direct consequence of:
- Intense Generic Competition: The presence of numerous manufacturers forces price reductions to remain competitive.
- Contractual Pricing: Pharmacy Benefit Managers (PBMs) and large payers negotiate deeply discounted prices through formulary placement and preferred drug status.
- Manufacturing Efficiencies: Generic manufacturers continuously optimize production processes to reduce cost of goods sold, enabling further price reductions.
- Limited Differentiation: Without significant therapeutic or formulation advantages, price becomes the primary decision-making factor for purchasers.
Projected Pricing (Next 3-5 Years):
- Continued Price Erosion: Expect the AWP to continue decreasing by approximately 7-12% annually.
- Low-Cost Environment: Prices will remain at levels reflective of a highly commoditized generic drug.
- Specific Price Points: While exact AWP will fluctuate based on individual manufacturer contracts and market dynamics, typical prices for a 30-day supply of Losartan Potassium (50 mg) could range from $5.00 to $8.00 USD at the pharmacy level for insured patients after co-pays, reflecting significantly lower underlying wholesale costs. Uninsured or cash-paying patients might face higher out-of-pocket costs depending on the pharmacy's mark-up, but the drug's intrinsic low cost will still be apparent.
- Bulk Purchasing: Large hospital systems and PBMs will likely secure even lower prices through volume commitments, potentially approaching or falling below $1.00 - $2.00 per 30-tablet bottle for certain contracts.
Factors Influencing Future Pricing:
- New Entrants: While unlikely for a mature drug like Losartan, any new generic manufacturer entering the market could temporarily intensify price competition.
- Supply Chain Disruptions: Global events (e.g., pandemics, geopolitical instability) can cause short-term price spikes or shortages, but these are typically temporary for well-established generics.
- Regulatory Changes: Changes in FDA pricing regulations or PBM oversight could indirectly influence pricing strategies, though direct impact on a mature generic is limited.
- Therapeutic Innovations: The development of novel antihypertensive treatments could eventually reduce the demand for older ARBs, but this is a long-term trend.
The pricing of Losartan Potassium is fundamentally driven by the economics of generic pharmaceuticals. Companies focused on this product should prioritize efficient manufacturing, robust supply chain management, and competitive bidding strategies.
Key Takeaways
- Losartan Potassium (NDC 16729-0008) is a generic medication with expired patent protection, leading to a highly competitive market.
- The drug is widely prescribed for hypertension and diabetic nephropathy, ensuring consistent demand driven by chronic disease prevalence.
- Price erosion is a continuous trend, with average wholesale prices expected to decline by 7-12% annually.
- Future pricing will remain low, with 30-day supplies potentially costing $5.00-$8.00 at the pharmacy level for insured patients, and significantly less for bulk institutional buyers.
- Market success hinges on manufacturing efficiency, supply chain reliability, and competitive pricing strategies.
Frequently Asked Questions
1. What is the typical manufacturing cost for Losartan Potassium per pill?
Precise manufacturing costs are proprietary to each company. However, for highly commoditized generics like Losartan Potassium, the cost of goods sold per pill is estimated to be in the range of $0.01 to $0.05 USD for large-scale producers.
2. Are there any known shortages of Losartan Potassium?
Historically, Losartan Potassium has experienced occasional recalls due to N-nitrosoamine impurity concerns, leading to temporary shortages. However, current market data does not indicate widespread or persistent shortages of the drug.
3. How does Losartan Potassium pricing compare to other ARBs?
Losartan Potassium is generally among the most affordably priced ARBs due to its longer history of generic availability compared to newer agents in the ARB class.
4. What is the role of Pharmacy Benefit Managers (PBMs) in Losartan Potassium pricing?
PBMs negotiate significant discounts from manufacturers and wholesalers on behalf of insurance companies. They use these negotiated prices to set co-pays for patients and determine preferred drug status on formularies, exerting substantial downward pressure on wholesale prices.
5. What is the projected market size for Losartan Potassium in the next five years?
While exact market size figures are proprietary, the global market for Losartan Potassium is estimated to be in the hundreds of millions of U.S. dollars annually, with steady demand due to its therapeutic importance and affordability. Growth is expected to be modest, reflecting the mature nature of the product.
Citations
[1] National Institutes of Health. (n.d.). Losartan. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a699080.html
[2] DailyMed. (n.d.). Losartan Potassium Tablet. National Library of Medicine. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a17450a4-0c4c-456b-bc74-205d42e19a45
[3] Food and Drug Administration. (n.d.). Losartan Potassium. FDA Approved Drugs. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&Appl_No=020273
[4] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). FDA. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
[5] Pharmaceutical Data Solutions. (n.d.). NDC 16729-0008 Product Information. Proprietary Database.
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