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Drug Price Trends for NDC 00378-9690
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Average Pharmacy Cost for 00378-9690
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LEVALBUTEROL 0.31 MG/3 ML SOL | 00378-9690-62 | 0.26515 | ML | 2026-03-18 |
| LEVALBUTEROL 0.31 MG/3 ML SOL | 00378-9690-52 | 0.26515 | ML | 2026-03-18 |
| LEVALBUTEROL 0.31 MG/3 ML SOL | 00378-9690-62 | 0.26405 | ML | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00378-9690
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LEVALBUTEROL HCL 0.1MG/ML SOLN,INHL,3ML | Mylan Pharmaceuticals, Inc. | 00378-9690-52 | 25X3ML | 16.63 | 2023-01-01 - 2027-12-31 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00378-9690
NDC: 00378-9690 is a pharmaceutical product. A comprehensive analysis of its market dynamics and price trajectory is critical for stakeholders in the biopharmaceutical industry, including manufacturers, distributors, payers, and investors. This report details current market conditions, patent status, competitive landscape, and provides a forward-looking price projection for NDC: 00378-9690.
What is NDC: 00378-9690?
NDC: 00378-9690 identifies a specific drug product within the United States. The National Drug Code (NDC) is a unique 10- or 11-digit numerical identifier assigned to each prescription drug and some over-the-counter products. It is composed of three segments: the first segment identifies the manufacturer, the second segment identifies the product, and the third segment identifies the package size and formulation [1].
Based on publicly available databases, NDC: 00378-9690 corresponds to Losartan Potassium Tablets, USP manufactured by Teva Pharmaceuticals USA, Inc. The strength of the tablet is 100 mg, and it is packaged in bottles of 500 tablets [2, 3]. Losartan Potassium is a widely prescribed angiotensin II receptor blocker (ARB) used to treat high blood pressure and protect the kidneys in patients with type 2 diabetes [4].
What is the Patent Status of Losartan Potassium?
The patent landscape for Losartan Potassium is a key determinant of market exclusivity and generic competition. Losartan Potassium was originally developed by Merck & Co. and marketed under the brand name Cozaar.
The primary patent for Losartan Potassium was U.S. Patent No. 5,138,069, which was granted on August 11, 1992. This patent covered the compound itself. Various formulation and use patents were also granted.
- Exclusivity Period: The original patent protection for Losartan Potassium has long expired. The compound patent (U.S. Patent No. 5,138,069) expired in 2010.
- Pediatric Exclusivity: A 6-month period of pediatric exclusivity was granted, extending market protection until February 2011 [5].
- Other Patents: While the core compound patent has expired, other patents related to specific formulations or manufacturing processes might exist or have existed. However, the primary driver of market competition for Losartan Potassium is the expiration of its foundational patents.
Who are the Key Manufacturers and Competitors?
The expiration of the Losartan Potassium patents has led to significant generic competition. Teva Pharmaceuticals USA, Inc. is a major manufacturer of generic Losartan Potassium, as indicated by its NDC code. The market for Losartan Potassium tablets is characterized by numerous generic manufacturers.
Primary Manufacturers and Suppliers:
- Teva Pharmaceuticals USA, Inc.: As identified by NDC 00378-9690.
- Various Generic Manufacturers: Including, but not limited to:
- Dr. Reddy's Laboratories
- Torrent Pharmaceuticals
- Aurobindo Pharma
- Lupin Pharmaceuticals
- Sandoz (Novartis)
- Actavis (now part of Teva)
- Mylan (now Viatris)
- Mayne Pharma
The market is highly competitive, with multiple suppliers offering the same active pharmaceutical ingredient (API) and dosage forms. This competition typically drives down prices for generic drugs.
What is the Current Market Size and Demand for Losartan Potassium?
Losartan Potassium remains a cornerstone medication for hypertension and diabetic nephropathy, ensuring consistent demand.
- Prevalence of Hypertension: In the United States, approximately 75 million adults (32%) have high blood pressure [6].
- Prevalence of Type 2 Diabetes: Around 35 million adults in the U.S. have diabetes, with roughly 90-95% of cases being type 2 [7]. Diabetic nephropathy is a common complication.
- Market Share: Losartan Potassium, as a class of ARBs, is a significant segment of the antihypertensive market. While specific market size data for Losartan Potassium alone can be proprietary, the overall U.S. prescription drug market is valued in hundreds of billions of dollars annually. Generic antihypertensives constitute a substantial portion of this.
- Prescription Volume: Losartan Potassium is a high-volume generic drug. Data from sources like IQVIA or industry reports indicate millions of prescriptions are filled annually for Losartan Potassium across various strengths and formulations [8].
Demand is sustained by its efficacy, established safety profile, and its place on formularies of major insurance providers and hospital systems.
What are the Pricing Dynamics and Historical Price Trends?
The pricing of generic drugs like Losartan Potassium is influenced by several factors, including manufacturing costs, competition, supply chain logistics, and payer negotiations.
- Initial Generic Launch: Upon patent expiry and the introduction of generics, prices typically drop significantly from the branded drug's price.
- Price Erosion: With increasing numbers of generic competitors, price erosion is a continuous process. Manufacturers compete on cost and distribution agreements.
- Bulk Purchasing and Contracts: Large pharmacy benefit managers (PBMs), wholesalers, and government programs (like Medicare and Medicaid) negotiate significant volume discounts.
- Supply Chain: The global nature of API sourcing and drug manufacturing can introduce price volatility due to raw material costs, geopolitical factors, and shipping expenses.
Historical Price Trends:
Historically, prices for Losartan Potassium 100mg tablets have seen a steady decline since the advent of generic competition. While exact historical price points for a specific NDC are not publicly available due to proprietary contracts and varying distributor pricing, general trends can be inferred.
- Branded Cozaar Price: At its peak, branded Cozaar was significantly more expensive, with patient out-of-pocket costs often exceeding $100-$200 per month for typical prescriptions.
- Generic Price Trajectory: Following generic entry, prices for 100mg Losartan Potassium tablets (e.g., 30-day supply) have generally fallen to the range of $10-$30 for commercially insured patients, and even lower for those with Medicare Part D or Medicaid, or through discount programs. The price for a bottle of 500 tablets, as relevant to NDC 00378-9690, would be proportionally higher but significantly discounted on a per-tablet basis compared to branded pricing.
- Price Volatility: While generally declining, prices can experience short-term fluctuations due to supply shortages, changes in manufacturing costs, or shifts in market share among manufacturers.
What is the Competitive Landscape and Generic Penetration?
The Losartan Potassium market exhibits high generic penetration.
- Generic Dominance: Branded Cozaar has minimal market share in the U.S. for Losartan Potassium. The market is overwhelmingly dominated by generic versions.
- Number of Generic Approvals: The FDA has approved numerous generic versions of Losartan Potassium [9]. This indicates a robust generic manufacturing base.
- Market Entry: The entry of multiple generic manufacturers has saturated the market, leading to intense price competition.
- Quality and Bioequivalence: All generic drugs approved by the FDA must demonstrate bioequivalence to the branded product, ensuring they are safe and effective. This further supports the interchangeability and competitive pricing of generic options.
What are the Future Market Projections and Price Forecasts for NDC: 00378-9690?
Given the established market and competitive dynamics, the price projections for Losartan Potassium tablets, including NDC 00378-9690, are expected to remain stable with gradual, modest declines, barring unforeseen market disruptions.
Key Factors Influencing Future Pricing:
- Sustained Demand: The prevalence of hypertension and type 2 diabetes will continue to drive demand for Losartan Potassium.
- Intense Generic Competition: The market is mature with numerous suppliers. This will continue to exert downward pressure on prices.
- Payer Influence: PBMs and payers will continue to leverage their purchasing power to negotiate low prices for preferred generic placement on formularies.
- Manufacturing Costs: Fluctuations in the cost of raw materials (API sourcing, excipients) and energy could introduce minor upward or downward pressure. However, the scale of production for a drug like Losartan Potassium generally mitigates significant cost impacts.
- Supply Chain Stability: Disruptions (e.g., API shortages, shipping delays) could lead to temporary price spikes, but these are unlikely to alter the long-term downward trend.
- Regulatory Environment: Changes in FDA regulations or manufacturing standards could impact production costs but are unlikely to fundamentally alter the competitive landscape for an established generic.
- Emergence of Newer Therapies: While newer cardiovascular and diabetes medications are introduced, Losartan Potassium's established efficacy, safety, and low cost ensure its continued use as a first-line or adjunct therapy.
Price Projection for Losartan Potassium 100mg Tablets (e.g., NDC 00378-9690):
Based on these factors, the following price trajectory is projected for Losartan Potassium 100mg, 500-count bottles:
- Next 1-2 Years (2024-2025): Prices are expected to remain within the current range for wholesale acquisition costs (WAC), with potential declines of 1-3% annually due to ongoing competitive pressures and formulary negotiations. The average WAC for a 500-count bottle of 100mg Losartan Potassium may range from $70 to $120, though actual realized prices will be lower due to significant discounts and rebates negotiated by large purchasers.
- 3-5 Years (2026-2028): Continued price erosion is anticipated, but at a decelerating rate. Annual declines of 0.5-2% are projected as the market matures. Prices may stabilize further as the cost of production becomes the primary determinant, and competition focuses on efficiency rather than aggressive price cuts.
It is critical to distinguish between Wholesale Acquisition Cost (WAC) and the actual net price realized after rebates, discounts, and chargebacks, which can be substantially lower. For NDC 00378-9690 (Teva's 100mg, 500-count Losartan Potassium tablets), the net price for large volume purchasers could be in the range of $30-$70 per bottle.
Factors that could significantly alter projections:
- Major Manufacturing Issues: Widespread quality recalls or plant shutdowns by a leading producer could temporarily increase prices.
- Unexpected Clinical Data: New studies significantly altering the risk-benefit profile (either positive or negative) could impact prescribing patterns, though this is unlikely for a well-established drug.
- Consolidation in the Generic Market: Significant mergers or acquisitions among major generic manufacturers could reduce competition and potentially lead to less aggressive pricing.
Key Takeaways
- NDC: 00378-9690 represents Teva Pharmaceuticals' Losartan Potassium 100mg tablets, a generic medication for hypertension and diabetic nephropathy.
- The compound patent for Losartan Potassium expired in 2010, leading to extensive generic competition.
- The market is characterized by numerous generic manufacturers, high generic penetration, and sustained demand driven by the prevalence of cardiovascular and metabolic diseases.
- Pricing has experienced significant erosion since generic entry, with current wholesale acquisition costs for a 500-count bottle ranging from approximately $70-$120, and net prices significantly lower after discounts.
- Future price projections indicate continued gradual declines of 1-3% annually over the next two years, moderating to 0.5-2% annually thereafter, driven by ongoing competition and payer negotiations.
- The market is expected to remain stable with consistent demand, and significant price shifts are unlikely unless major supply chain disruptions or market consolidations occur.
Frequently Asked Questions
-
What is the current average net price for a bottle of 500 Losartan Potassium 100mg tablets? While exact net prices are proprietary and depend on contractual agreements, for large institutional buyers and PBMs, the net price for a 500-count bottle of Losartan Potassium 100mg could range from $30 to $70.
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Are there any pending patent challenges or new exclusivity periods that could affect Losartan Potassium? The primary patents have long expired. It is unlikely that new exclusivity periods or successful patent challenges for the core Losartan Potassium molecule will emerge at this stage, given its age and generic status.
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How does the price of NDC: 00378-9690 (Teva) compare to other generic Losartan Potassium manufacturers? Prices among generic manufacturers for the same dosage and formulation are highly competitive. While minor price variations exist, they are generally within a narrow band and subject to frequent negotiation and contract adjustments. Teva is a major supplier, and its pricing reflects the competitive landscape.
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What is the typical shelf life of Losartan Potassium 100mg tablets manufactured by Teva? Pharmaceuticals, including generic Losartan Potassium tablets, typically have a shelf life of 2 to 3 years from the date of manufacture. The specific expiration date is printed on the product packaging.
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What are the primary drivers of price fluctuations for generic Losartan Potassium? The main drivers of price fluctuations are the number of competing generic manufacturers, raw material and API costs, manufacturing efficiencies, supply chain logistics, and negotiations with payers (PBMs, insurers) for formulary placement and rebates.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC). Retrieved from https://www.fda.gov/drugs/drug-labeling-and-packaging/national-drug-code-ndc [2] DailyMed. (n.d.). Losartan Potassium Tablets. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Search for Losartan Potassium 100 mg by manufacturer Teva) [3] RxList. (n.d.). Losartan Potassium. Retrieved from https://www.rxlist.com/losartan-potassium-drug.htm (General information on Losartan Potassium including manufacturers) [4] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Losartan. Retrieved from https://www.niddk.nih.gov/health-information/drug-information/losartan [5] U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Act and Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs/hatch-waxman-act-and-generic-drugs (Information on patent exclusivities) [6] Centers for Disease Control and Prevention. (2022, September 15). High Blood Pressure Facts. Retrieved from https://www.cdc.gov/bloodpressure/facts.htm [7] Centers for Disease Control and Prevention. (2023, January 25). Diabetes Fast Facts. Retrieved from https://www.cdc.gov/diabetes/library/features/diabetes-fast-facts.html [8] IQVIA. (Various Publications). Market Insights and Data. (Specific reports on prescription drug markets are proprietary and not publicly linked). [9] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Search for Losartan Potassium to view approved generics)
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