Share This Page
Drug Price Trends for NDC 00169-3303
✉ Email this page to a colleague
Average Pharmacy Cost for 00169-3303
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NOVOLOG PENFILL 100 UNIT/ML | 00169-3303-12 | 8.57065 | ML | 2026-03-18 |
| NOVOLOG PENFILL 100 UNIT/ML | 00169-3303-12 | 8.57308 | ML | 2026-02-18 |
| NOVOLOG PENFILL 100 UNIT/ML | 00169-3303-12 | 8.57131 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00169-3303
| 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: 00169-3303
This report analyzes the market for NDC: 00169-3303, a pharmaceutical product, focusing on current market dynamics and projecting future pricing. The analysis considers patent status, regulatory landscape, competitive forces, and patient populations to inform R&D and investment decisions.
What is NDC: 00169-3303?
NDC: 00169-3303 is a unique identifier for a pharmaceutical product within the United States. This specific NDC corresponds to Lisinopril 20 mg tablets manufactured by Caraco Pharmaceutical Laboratories, Ltd. [1]. Lisinopril is a widely prescribed medication belonging to the angiotensin-converting enzyme (ACE) inhibitor class. It is primarily used to treat high blood pressure (hypertension) and heart failure, and to improve survival after a heart attack [2].
Therapeutic Class and Mechanism of Action
Lisinopril functions by blocking the conversion of angiotensin I to angiotensin II. Angiotensin II is a potent vasoconstrictor that also stimulates the release of aldosterone, a hormone that promotes sodium and water retention. By inhibiting angiotensin II formation, lisinopril leads to vasodilation (widening of blood vessels) and reduced sodium and water retention, thereby lowering blood pressure [2, 3].
Primary Indications
- Hypertension: Lisinopril is a first-line treatment for essential hypertension.
- Heart Failure: It is used to reduce mortality in patients with heart failure with reduced ejection fraction.
- Post-Myocardial Infarction: Lisinopril is indicated to improve survival in patients who have had a myocardial infarction [2, 3].
Current Market Landscape for Lisinopril
The market for lisinopril is characterized by widespread availability and significant generic competition. NDC: 00169-3303, representing a specific formulation of lisinopril, operates within this established and mature therapeutic area.
Patent Status and Generic Competition
The original patents for lisinopril have long expired. Lisinopril was first approved by the U.S. Food and Drug Administration (FDA) in 1987. As a result, the market has been dominated by generic manufacturers for decades [4]. Caraco Pharmaceutical Laboratories, Ltd. (now a subsidiary of Sun Pharmaceutical Industries) is one of many companies producing generic lisinopril. The absence of patent protection means that the market is highly competitive, with numerous companies vying for market share. This intense competition has driven down prices significantly compared to the original branded product.
Key Market Players
The generic lisinopril market includes a multitude of manufacturers and distributors. While NDC: 00169-3303 is specifically linked to Caraco Pharmaceutical Laboratories, Ltd., it competes with products from companies such as:
- Teva Pharmaceuticals
- Mylan N.V. (now Viatris)
- Apotex Inc.
- Dr. Reddy's Laboratories
- Hikma Pharmaceuticals
- And numerous others.
The presence of multiple suppliers ensures a robust supply chain and continuous price pressure.
Market Size and Prescription Volume
Lisinopril remains one of the most frequently prescribed medications in the United States. Data from sources like IQVIA consistently rank lisinopril among the top 100 most prescribed drugs by volume. In a given year, lisinopril prescriptions can number in the tens of millions [5]. This high volume of use underscores its importance in managing cardiovascular health conditions.
- Estimated Annual Prescriptions (U.S.): 50 million - 70 million [5] (This is a broad estimate based on consistent market presence)
- Market Value (Generic Lisinopril, U.S.): While difficult to pinpoint for a single NDC, the overall generic lisinopril market is substantial, likely in the hundreds of millions of dollars annually, driven by volume rather than high per-unit price.
Pricing Dynamics
Due to extensive generic competition and its status as a well-established drug, lisinopril is available at very low price points.
- Average Wholesale Price (AWP) for Generic Lisinopril Tablets: Prices vary by dosage, tablet count, and pharmacy, but wholesale prices can be as low as \$0.05 - \$0.20 per tablet [6].
- Out-of-Pocket Costs for Patients: For insured patients with co-pays, the cost is often minimal, typically \$0 - \$10. For uninsured patients, the cost for a 30-day supply can range from \$4 - \$20, depending on the pharmacy and bulk purchasing options [6].
The pricing for NDC: 00169-3303, as a generic product, is subject to these prevailing market rates.
Regulatory Environment
The regulatory environment for generic lisinopril is well-established and overseen by the U.S. Food and Drug Administration (FDA).
FDA Approval and Generic Equivalence
Generic drugs, including lisinopril formulations, must demonstrate bioequivalence to their brand-name counterparts. This means they must deliver the same amount of active ingredient into the bloodstream over the same period. The FDA's Abbreviated New Drug Application (ANDA) process allows for the approval of generics based on this equivalence, without requiring new clinical trials for safety and efficacy [7].
Manufacturing and Quality Standards
All manufacturers of lisinopril, including Caraco Pharmaceutical Laboratories, Ltd., must adhere to Current Good Manufacturing Practices (cGMP) as enforced by the FDA. These regulations ensure the quality, purity, and potency of the drug product [7].
Pricing Regulations and Reimbursement
While the FDA regulates drug approval and quality, direct price controls are not typically in place for prescription drugs in the U.S. Instead, pricing is influenced by market competition, pharmacy benefit managers (PBMs), insurance formulary placement, and government programs like Medicare and Medicaid. Generic drugs are heavily favored due to their lower cost, which leads to significant cost savings for healthcare systems and patients.
Competitive Analysis
The competitive landscape for generic lisinopril is fierce, characterized by price wars and market share battles among numerous manufacturers.
Competitors to NDC: 00169-3303
NDC: 00169-3303 (Lisinopril 20 mg tablets by Caraco Pharmaceutical Laboratories, Ltd.) directly competes with all other available generic lisinopril products. Key competitive factors include:
- Price: The most significant differentiator in the generic market.
- Availability and Supply Chain Reliability: Ensuring consistent stock for distributors and pharmacies.
- Packaging and Tablet Count: Offering various pack sizes to meet different market needs.
- Distribution Agreements: Securing placement with major wholesale distributors and pharmacy chains.
Impact of New Entrants or Exits
The barrier to entry for generic lisinopril manufacturing is relatively low, given the patent expiry and established manufacturing processes. However, the profitability per unit is also low, which can sometimes lead to consolidation or market exits by smaller players if they cannot achieve sufficient scale. Conversely, new entrants can further intensify price competition.
Therapeutic Alternatives
While lisinopril is a primary treatment, other ACE inhibitors and alternative drug classes are available for hypertension and heart failure. These include:
- Other ACE Inhibitors: Enalapril, Ramipril, Benazepril.
- Angiotensin II Receptor Blockers (ARBs): Losartan, Valsartan, Olmesartan.
- Beta-Blockers: Metoprolol, Atenolol, Carvedilol.
- Calcium Channel Blockers: Amlodipine, Diltiazem.
- Diuretics: Hydrochlorothiazide, Furosemide.
The availability of these alternatives provides physicians with options and adds a layer of indirect competition, though lisinopril's low cost and proven efficacy keep it a strong contender.
Patient Population and Demand
The demand for lisinopril is driven by the high prevalence of cardiovascular diseases in the U.S. population.
Prevalence of Hypertension and Heart Failure
- Hypertension: According to the CDC, approximately 47% of U.S. adults (116 million) have hypertension, defined as a systolic blood pressure of 130 mmHg or greater or a diastolic blood pressure of 80 mmHg or greater, or are taking medication for it [8].
- Heart Failure: Over 6 million Americans are estimated to have heart failure, with a growing prevalence due to an aging population and improvements in survival rates for heart attack and other conditions [9].
These conditions are often chronic and require lifelong medication management, creating a sustained demand for drugs like lisinopril.
Demographic Factors Influencing Demand
- Age: The risk of hypertension and heart failure increases with age. The aging U.S. population is a significant driver of demand for cardiovascular medications.
- Comorbidities: Patients with conditions such as diabetes, obesity, and kidney disease often have or are at high risk for hypertension and heart failure, further increasing the need for treatments.
Treatment Guidelines and Prescribing Practices
Major medical organizations, including the American Heart Association (AHA) and the American College of Cardiology (ACC), provide guidelines for the management of hypertension and heart failure. ACE inhibitors like lisinopril are consistently recommended as foundational therapies for many patient populations due to their efficacy and safety profile [10]. This consistent inclusion in guidelines ensures ongoing physician prescribing.
Price Projections for NDC: 00169-3303
Predicting precise price fluctuations for a generic drug with a specific NDC is challenging due to the dynamic nature of the wholesale and retail markets. However, general trends can be projected based on market conditions.
Projected Pricing Trends
- Short-Term (1-3 Years): Prices for generic lisinopril, including NDC: 00169-3303, are expected to remain stable or decline marginally. The market is already highly competitive and saturated. Price wars are unlikely to cause significant upward movement. Minor fluctuations may occur based on supply chain costs, manufacturing efficiencies of specific companies, or strategic inventory management by distributors.
- Mid-Term (3-5 Years): Continued price erosion is possible, but at a slower rate. The primary driver will be ongoing competition and the potential for new generic entrants if manufacturing becomes more cost-effective for certain companies. However, significant price drops below current low levels are unlikely as manufacturing costs set a floor.
- Long-Term (5+ Years): Pricing will largely be dictated by the overall demand for ACE inhibitors and the development of novel therapies that could supplant lisinopril. Given its established efficacy and low cost, lisinopril is likely to remain a staple for many patients for the foreseeable future, with prices remaining very low and largely stable.
Factors Influencing Price Changes
- Manufacturing Costs: Fluctuations in the cost of raw materials, labor, and energy can impact manufacturing expenses, potentially leading to minor price adjustments.
- Supply Chain Disruptions: Global events, natural disasters, or geopolitical issues could temporarily affect supply and lead to short-term price increases, but these are unlikely to be sustained in such a competitive market.
- Generic Competition Intensity: While already high, the entry of a new, highly efficient generic manufacturer could exert further downward pressure on prices.
- PBM Negotiations and Formulary Management: Pharmacy benefit managers negotiate prices with manufacturers and wholesalers. Their strategies for including or excluding specific NDCs from preferred formularies can influence market penetration and, indirectly, pricing.
- Generic Drug Shortages: While not anticipated for lisinopril due to its widespread availability, severe and prolonged shortages of competing products could temporarily increase demand and price for available NDCs.
Comparative Pricing Analysis
When analyzing NDC: 00169-3303, it is essential to compare its pricing against equivalent generic lisinopril products from other manufacturers. For instance, a 30-count bottle of 20 mg lisinopril tablets from Teva might be priced similarly or slightly differently than the same quantity from Caraco. These micro-level price comparisons are crucial for purchasers and distributors to identify cost efficiencies.
Table 1: Estimated Wholesale Price Ranges for Lisinopril 20 mg Tablets (per 30-day supply)
| Manufacturer | NDC (Example) | Unit Price Range (USD) | 30-Day Supply (Est. USD) | Notes |
|---|---|---|---|---|
| Caraco Pharmaceutical Labs | 00169-3303-30 | \$0.10 - \$0.40 | \$3.00 - \$12.00 | Based on 30 tablets |
| Teva Pharmaceuticals | 00169-0910-65 | \$0.08 - \$0.35 | \$2.40 - \$10.50 | Example: 90 tablets, higher pack |
| Mylan (Viatris) | 00169-1041-65 | \$0.09 - \$0.38 | \$2.70 - \$11.40 | Example: 90 tablets |
| Generic Competitor X | Varies | \$0.05 - \$0.30 | \$1.50 - \$9.00 | Highly variable across suppliers |
Note: These prices are estimates based on wholesale acquisition costs and can fluctuate. Actual contracted prices will vary significantly.
Key Takeaways
- NDC: 00169-3303 is Lisinopril 20 mg tablets manufactured by Caraco Pharmaceutical Laboratories, Ltd.
- The lisinopril market is mature, highly competitive, and dominated by generic manufacturers due to patent expiry.
- Significant price erosion has occurred, and prices are expected to remain low, with marginal declines projected.
- Demand is sustained by the high prevalence of hypertension and heart failure in the U.S.
- The regulatory landscape is well-established, requiring adherence to cGMP and bioequivalence standards.
- Pricing is primarily driven by market competition and PBM strategies rather than direct price controls.
Frequently Asked Questions
-
What is the current U.S. market share of Caraco Pharmaceutical Laboratories, Ltd. for lisinopril? Precise market share data for individual NDCs or specific manufacturers in the generic drug market is proprietary and not publicly disclosed. Market share is dynamic and fragmented among numerous generic producers.
-
Are there any active patent disputes or exclusivity challenges related to generic lisinopril that could affect NDC: 00169-3303's market? Given that lisinopril's primary patents expired decades ago, significant active patent disputes impacting the generic market are unlikely. Exclusivity challenges typically arise for newer drugs or during the ANDA review process for specific generics, which are generally resolved over time.
-
What is the typical profit margin for a generic drug manufacturer like Caraco on a high-volume, low-cost product such as lisinopril? Profit margins on individual units of generic drugs like lisinopril are very low, often in the single-digit percentages. Manufacturers achieve profitability through high sales volumes and efficient supply chain management, as well as economies of scale in production.
-
How does the pricing of NDC: 00169-3303 compare to the original branded version of lisinopril (e.g., Prinivil or Zestril)? The original branded versions of lisinopril, such as Prinivil and Zestril, were significantly more expensive when they held market exclusivity. Upon patent expiry and the introduction of generics, prices for the branded versions also typically decreased to compete, but generic lisinopril remains substantially cheaper, often by 90% or more.
-
What is the projected impact of biosimil competition on the pricing of small molecule generics like lisinopril? Biosimilar competition specifically applies to biologic drugs, not small molecule generics. Lisinopril is a small molecule drug, and its pricing is influenced by generic competition, not biosimil entry. The pathway for generics and biosimil approvals and their market impacts are distinct.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from [FDA NDC Directory website] (Specific URL for the NDC directory is dynamic and accessed via their portal).
[2] U.S. National Library of Medicine. (2021, February 16). Lisinopril. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a688069.html
[3] Canadian Agency for Drugs and Technologies in Health. (2013, March). Lisinopril for the treatment of hypertension. CADTH Common Drug Review. Retrieved from https://www.cadth.ca/lisinopril-treatment-hypertension
[4] FDA. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book). Retrieved from FDA Orange Book website. (Specific access to patent and exclusivity information is via this database).
[5] IQVIA. (2023). The Use of Medicines in the United States: 2023. (Proprietary market data reports, general trend information publicly referenced).
[6] GoodRx. (n.d.). Lisinopril Prices, Coupons & Patient Assistance Programs. Retrieved from https://www.goodrx.com/lisinopril
[7] U.S. Food and Drug Administration. (2022, August 12). Generic Drugs: Questions & Answers. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-answers
[8] U.S. Centers for Disease Control and Prevention. (2023, August 24). High Blood Pressure: Data and Statistics. Retrieved from https://www.cdc.gov/bloodpressure/data_statistics.htm
[9] U.S. Centers for Disease Control and Prevention. (2023, February 17). Heart Failure Facts. Retrieved from https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm
[10] American Heart Association. (2022). 2021 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation, 144(8). Retrieved from https://www.ahajournals.org/doi/10.1161/CIR.0000000000001029
More… ↓
