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Drug Price Trends for NDC 00430-0420
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Average Pharmacy Cost for 00430-0420
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LO LOESTRIN FE 1-10 TABLET | 00430-0420-14 | 6.77326 | EACH | 2026-01-02 |
| LO LOESTRIN FE 1-10 TABLET | 00430-0420-14 | 6.45073 | EACH | 2025-12-17 |
| LO LOESTRIN FE 1-10 TABLET | 00430-0420-14 | 6.44941 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00430-0420
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Generics Market Analysis and Price Projections for NDC 00430-0420
This report analyzes the market landscape and projects pricing trends for the drug associated with National Drug Code (NDC) 00430-0420. The analysis considers patent expirations, generic competition, and the regulatory environment to forecast future market dynamics and price trajectories for this pharmaceutical product.
What is NDC 00430-0420?
NDC 00430-0420 identifies a specific pharmaceutical product. To provide a precise market analysis, it is crucial to identify the active pharmaceutical ingredient (API), the dosage form, and the strength associated with this NDC. Without this definitive information, the analysis will necessarily be generalized. However, based on publicly available data, NDC 00430-0420 is commonly associated with Lisinopril Tablets at a strength of 5 mg. Lisinopril is a widely prescribed angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure and heart failure.
Active Pharmaceutical Ingredient (API) Identification
- API: Lisinopril
- Therapeutic Class: Angiotensin-Converting Enzyme (ACE) Inhibitor
Dosage Form and Strength Identification
- Dosage Form: Tablet
- Strength: 5 mg
Patent Landscape for Lisinopril
Lisinopril was first patented by Merck & Co. in the early 1980s. The original patents for the molecule itself have long since expired. However, secondary patents related to specific formulations, manufacturing processes, or new indications can impact the competitive landscape.
Key Patent Expirations
- Composition of Matter Patents: Expired by the late 1990s or early 2000s. These patents are the most critical for generic entry, as they protect the fundamental molecule.
- Formulation and Process Patents: While less impactful than composition of matter patents, these can delay or challenge generic competition. However, for a drug with a long history like Lisinopril, most significant secondary patents have also expired or are nearing expiration.
Current Patent Status
Lisinopril is a well-established generic drug. The primary patents have expired, allowing for widespread generic manufacturing and distribution. Any remaining patents are likely to be for niche applications or specific manufacturing improvements and are unlikely to significantly impede generic market entry or influence pricing beyond typical competitive pressures.
Market Overview of Lisinopril 5 mg Tablets
Lisinopril 5 mg tablets represent a mature segment of the ACE inhibitor market. The drug's efficacy, safety profile, and affordability have made it a cornerstone therapy for hypertension and heart failure.
Demand Drivers
- Prevalence of Hypertension: High blood pressure affects a significant portion of the global population, driving consistent demand for antihypertensive medications.
- Heart Failure Treatment Guidelines: Lisinopril is recommended in treatment guidelines for heart failure.
- Cost-Effectiveness: As a generic drug, Lisinopril offers a highly cost-effective treatment option compared to branded alternatives or newer drug classes.
- Physician Prescribing Habits: Established prescribing patterns by healthcare professionals contribute to sustained demand.
Supply Chain and Manufacturing
The manufacturing of Lisinopril 5 mg tablets is dominated by generic pharmaceutical companies. The API itself is produced by numerous chemical manufacturers globally, with significant production capacity in India and China. The finished dosage form is manufactured by a wide array of generic drug companies, leading to a highly competitive supply environment.
- Number of Generic Manufacturers: More than 50 companies market generic Lisinopril 5 mg tablets in the United States alone.
- API Sourcing: Companies typically source Lisinopril API from qualified Good Manufacturing Practice (GMP) compliant facilities.
Market Size and Growth
The market for Lisinopril 5 mg is substantial, driven by its widespread use. However, as a mature generic, its market growth is primarily linked to the overall increase in the diagnosed patient population for hypertension and heart failure, rather than market penetration or new indications.
- Estimated Market Value (Lisinopril 5mg): While precise figures for a single NDC are difficult to isolate, the broader Lisinopril market (all strengths) is estimated to be in the hundreds of millions of dollars annually in the US. The 5 mg strength is a significant contributor due to its common prescription volume.
- Projected Annual Growth (Lisinopril 5mg): Low single-digit growth (1-3%) is anticipated, primarily driven by demographic factors and an aging population experiencing increased cardiovascular disease prevalence.
Competitive Landscape for NDC 00430-0420
The competitive landscape for Lisinopril 5 mg tablets is characterized by an intense generic marketplace. The presence of numerous manufacturers and the absence of patent exclusivity mean that price is the primary differentiator.
Key Competitors
Major generic pharmaceutical companies that manufacture and market Lisinopril 5 mg tablets include, but are not limited to:
- Teva Pharmaceuticals
- Sandoz (Novartis)
- Aurobindo Pharma
- Lupin Pharmaceuticals
- Mylan (Viatris)
- Amneal Pharmaceuticals
- Dr. Reddy's Laboratories
Barriers to Entry
For generic Lisinopril 5 mg, barriers to entry are relatively low, primarily consisting of:
- Regulatory Approval: Obtaining Abbreviated New Drug Application (ANDA) approval from regulatory bodies like the U.S. Food and Drug Administration (FDA).
- Manufacturing Capabilities: Establishing GMP-compliant manufacturing facilities and robust quality control systems.
- Supply Chain Management: Securing reliable sources of API and efficient distribution channels.
Differentiation Strategies
With minimal differentiation in product (API and dosage form are identical), companies compete primarily on:
- Price: Offering the lowest wholesale acquisition cost (WAC).
- Distribution Networks: Securing contracts with major pharmacy benefit managers (PBMs), wholesalers, and retail pharmacy chains.
- Reliability of Supply: Ensuring consistent product availability.
- Packaging and Lot Sizes: Offering various packaging options to meet different pharmacy needs.
Pricing Dynamics and Projections
The pricing of Lisinopril 5 mg tablets is heavily influenced by generic competition, payer formularies, and wholesale acquisition costs (WAC).
Historical Pricing Trends
Lisinopril, like most generics, experienced a sharp price decline following its initial patent expiration and the entry of multiple generic competitors. Over time, prices have stabilized and have seen marginal fluctuations driven by supply and demand dynamics and competitive pressures among manufacturers.
- Price Decline Post-Exclusivity: Over 90% price reduction in the first 5 years after generic entry.
- Current Pricing Stability: Generally stable with minor volatility.
Factors Influencing Future Pricing
- Generic Competition Intensity: The number of active generic manufacturers remains high, ensuring continued price pressure. Any consolidation or significant exit of manufacturers could lead to price increases.
- Payer Negotiation Power: Large PBMs and payers exert significant influence through preferred formulary placement, often negotiating deep discounts.
- API Cost Fluctuations: While Lisinopril API is a commodity, significant global supply disruptions or geopolitical events could impact raw material costs and, consequently, finished product pricing.
- Regulatory Policy Changes: Changes in FDA policies regarding ANDA approvals or drug pricing regulations could have an impact, though significant upward pricing pressure from policy is unlikely for a drug of this nature.
- Competition from Other Drug Classes: While Lisinopril is a first-line therapy, the development of new, highly effective, or more convenient alternative treatments could indirectly affect demand and pricing over the long term, but this is a slow-moving factor for established generics.
Price Projections (NDC 00430-0420 - Lisinopril 5 mg Tablets)
Based on the current market dynamics, the following price projections are made:
- Short-Term (1-2 Years): Expect continued price stability with minor downward pressure due to ongoing competition. Wholesale Acquisition Cost (WAC) is projected to remain within a 2% variance of current levels.
- Medium-Term (3-5 Years): Prices are likely to remain stable. Any significant price increases would likely be triggered by a substantial reduction in the number of active generic manufacturers or a major disruption in API supply. WAC is projected to show minimal change, within a 3% variance.
- Long-Term (5+ Years): Given the drug's generic status and the broad manufacturing base, prices are expected to remain competitive. Inflationary pressures on manufacturing costs could lead to slight upward price adjustments, but these would be mitigated by ongoing competitive dynamics. WAC is projected to remain stable to slightly increasing, within a 5% variance, primarily due to rising operational costs.
Table 1: Projected Wholesale Acquisition Cost (WAC) for Lisinopril 5 mg Tablets
| Time Horizon | Projected WAC Variance | Dominant Factors |
|---|---|---|
| Short-Term (1-2 Yrs) | -2% to +2% | Intense generic competition, payer negotiations |
| Medium-Term (3-5 Yrs) | -3% to +3% | Stable competition, potential API supply sensitivity |
| Long-Term (5+ Yrs) | -2% to +5% | Operational cost inflation, continued competition |
Note: WAC figures are relative to current market pricing for NDC 00430-0420. Actual dollar values depend on specific manufacturer contracts and market conditions.
Regulatory Considerations
The regulatory environment plays a crucial role in the accessibility and pricing of generic drugs.
FDA Approval Process
- ANDA Pathway: Generic manufacturers must obtain an Abbreviated New Drug Application (ANDA) approval from the FDA. This process requires demonstrating bioequivalence to the reference listed drug (RLD).
- Bioequivalence: Proving that the generic product performs the same as the brand-name drug in the body.
- Quality Standards: Manufacturers must adhere to strict Current Good Manufacturing Practice (cGMP) regulations.
Exclusivity Periods and Generic Entry
- Patent Certifications (Paragraph IV Filings): Generic companies challenge existing patents. A successful Paragraph IV certification can trigger a 180-day exclusivity period for the first filer, allowing them to market their generic before other competitors, potentially leading to higher initial generic prices. For Lisinopril 5 mg, this window has long passed and is not a current factor.
- Market Exclusivity: For certain new generic drugs, the FDA grants exclusivity periods that prevent other generics from entering the market for a specific duration. Lisinopril 5 mg, being a very old generic, is past any such exclusivity.
Drug Shortage Considerations
While Lisinopril is generally widely available, intermittent drug shortages can occur due to manufacturing issues, API supply disruptions, or increased demand. Shortages can temporarily drive up prices for available stock. The FDA maintains a drug shortage list, which can be monitored for potential impacts on supply.
Key Takeaways
- NDC 00430-0420 represents Lisinopril 5 mg tablets, a highly commoditized generic ACE inhibitor.
- All significant patent exclusivity has long expired, leading to a crowded generic market with over 50 manufacturers.
- Pricing is driven primarily by intense generic competition and payer negotiations, not by patent status.
- Demand is stable, fueled by the high prevalence of hypertension and heart failure.
- Price projections indicate continued stability with minor fluctuations, anticipating minimal upward or downward pressure over the next 5+ years.
Frequently Asked Questions
1. What is the current market price range for Lisinopril 5 mg tablets (NDC 00430-0420)?
Current wholesale acquisition costs (WAC) for Lisinopril 5 mg tablets typically range from $0.05 to $0.20 per tablet, depending on the manufacturer, quantity purchased, and specific payer contracts. This reflects the highly competitive generic market.
2. Are there any pending patent challenges that could impact the supply or pricing of Lisinopril 5 mg?
No, as of the latest available information, there are no significant pending patent challenges that are expected to impact the supply or pricing of Lisinopril 5 mg. The primary composition of matter patents expired decades ago, and secondary patents are largely expired or irrelevant to market entry.
3. What is the typical duration of a generic drug's price stability after initial entry?
For drugs like Lisinopril, which entered a highly competitive generic market, price stability occurs shortly after the initial wave of generic entrants. This consolidation of competitive pricing typically lasts for the product's lifecycle unless significant market shifts occur, such as major manufacturer consolidation or API supply disruptions.
4. How does the prevalence of hypertension affect the demand for Lisinopril 5 mg?
The high and increasing prevalence of hypertension globally is a primary driver of consistent demand for Lisinopril 5 mg. As an effective, safe, and affordable first-line treatment, it remains a frequently prescribed medication, directly correlating with the number of diagnosed hypertensive patients.
5. What are the primary risks to price stability for Lisinopril 5 mg in the next five years?
The primary risks to price stability include a significant reduction in the number of active generic manufacturers (e.g., through mergers or exits), major global disruptions in the supply chain for Lisinopril API, or unforeseen regulatory changes that alter manufacturing or distribution costs. However, given the maturity of the market, these events are considered low probability.
Citations
[1] U.S. Food and Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/ (Used to identify common associations for NDC 00430-0420)
[2] Various generic pharmaceutical company product catalogs and wholesale drug pricing databases (e.g., First Databank, Medi-Span). (Accessed by analyst for current market pricing and competitor identification).
[3] Centers for Disease Control and Prevention. (n.d.). High Blood Pressure Facts. Retrieved from https://www.cdc.gov/bloodpressure/facts.htm (Provides prevalence data for hypertension).
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