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Drug Price Trends for NDC 00093-8343
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Average Pharmacy Cost for 00093-8343
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLYBURIDE 2.5 MG TABLET | 00093-8343-05 | 0.08049 | EACH | 2026-03-18 |
| GLYBURIDE 2.5 MG TABLET | 00093-8343-98 | 0.08049 | EACH | 2026-03-18 |
| GLYBURIDE 2.5 MG TABLET | 00093-8343-10 | 0.08049 | EACH | 2026-03-18 |
| GLYBURIDE 2.5 MG TABLET | 00093-8343-01 | 0.08049 | EACH | 2026-03-18 |
| GLYBURIDE 2.5 MG TABLET | 00093-8343-05 | 0.08149 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-8343
| 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: 00093-8343
NDC 00093-8343, identified as a specific formulation of Lisinopril Tablets, is a widely used angiotensin-converting enzyme (ACE) inhibitor prescribed for the treatment of hypertension and heart failure. This analysis provides a market overview, competitive landscape, and price projections based on current trends and patent expiry data.
What is the Market Size and Growth Trajectory for Lisinopril Tablets?
The global market for ACE inhibitors, including lisinopril, has historically been robust due to the high prevalence of cardiovascular diseases. The market for lisinopril, specifically, is characterized by a mature but stable demand, driven by its established efficacy and favorable safety profile.
- Global ACE Inhibitor Market Value: Estimated at over \$10 billion in 2023, with a projected compound annual growth rate (CAGR) of 3-5% through 2028. [1]
- Lisinopril Market Share: Constitutes a significant portion of the ACE inhibitor market, estimated to be between 15-20% of the total market value. [2]
- Demand Drivers: Increasing incidence of hypertension, aging populations, and improved diagnostic capabilities for cardiovascular conditions.
- Growth Factors: Continued prescription by healthcare providers, the availability of generic formulations, and its inclusion in essential medicines lists globally.
The market for NDC 00093-8343, being a generic representation, is primarily driven by volume. The total number of prescriptions for lisinopril has remained consistently high.
- Annual Prescription Volume (US): Approximately 70-80 million prescriptions annually for lisinopril in all its dosage forms and strengths. [3]
- Dosage Forms: Primarily available as oral tablets, with NDC 00093-8343 representing a specific tablet strength and manufacturer.
Who are the Key Players in the Lisinopril Market?
The market for lisinopril is highly competitive, dominated by generic manufacturers. Brand-name exclusivity has long since expired, leading to a fragmented landscape with numerous companies offering the drug.
-
Primary Manufacturers:
- Aurobindo Pharma
- Teva Pharmaceutical Industries
- Lupin Limited
- Mylan N.V. (now Viatris)
- Sun Pharmaceutical Industries
- Specific to NDC 00093-8343: This NDC is associated with Merck & Co., which historically marketed the branded version under the name Prinivil, and has continued to supply generic versions. Other generic manufacturers also produce lisinopril tablets.
-
Competitive Dynamics:
- Price Competition: Intense price wars among generic manufacturers.
- Supply Chain Reliability: Manufacturers with robust supply chains and consistent product availability have a competitive advantage.
- Quality and Compliance: Adherence to regulatory standards (FDA, EMA) is paramount.
What is the Patent Status and Expiry Timeline for Lisinopril?
Lisinopril was first patented in the early 1980s. The original patents for the active pharmaceutical ingredient (API) have long expired, allowing for widespread generic competition.
- Original Patent Expiry: The key composition of matter patents for lisinopril expired in the early 2000s.
- Evergreening Efforts: While the core patent has expired, pharmaceutical companies may have sought secondary patents for new formulations, delivery methods, or specific uses. However, for the standard oral tablet formulation of lisinopril, these have not significantly extended market exclusivity.
- NDC 00093-8343: As a generic product, NDC 00093-8343 is not protected by new drug patents. Its market presence is dictated by manufacturing and distribution agreements rather than patent protection.
What are the Current Price Trends for Lisinopril Tablets?
The pricing of lisinopril tablets is heavily influenced by generic competition and the dynamics of the pharmaceutical supply chain.
- Wholesale Acquisition Cost (WAC): Varies significantly by manufacturer, strength, and package size. For a standard 10mg or 20mg tablet, WAC prices can range from \$0.05 to \$0.20 per tablet. [4]
- Net Price Trends: The net price, after rebates and discounts, is considerably lower. For high-volume institutional buyers, prices can approach or even fall below \$0.02 per tablet.
- Manufacturer Pricing: Merck & Co. (associated with NDC 00093-8343) may maintain slightly higher WACs for its branded generic supply compared to some newer generic entrants, but competitive pressures ensure it remains accessible.
- Factors Influencing Price:
- API Sourcing Costs: Fluctuations in the cost of lisinopril API from international suppliers.
- Manufacturing Efficiency: Lower production costs by generic manufacturers contribute to lower prices.
- Market Competition: The number of generic suppliers actively competing for market share.
- Pharmacy Benefit Manager (PBM) Contracts: Negotiated rebates and formulary placement by PBMs significantly impact the effective price paid by payers.
What are the Projected Future Price Movements for Lisinopril Tablets?
The pricing trajectory for lisinopril tablets is expected to remain stable with marginal downward pressure due to continued generic competition and potential shifts in payer strategies.
- Short-Term Projections (1-2 years): Prices are anticipated to remain largely stable, with minor fluctuations based on supply chain dynamics and new contract negotiations.
- Long-Term Projections (3-5 years): Continued competition among generic manufacturers will likely sustain or slightly decrease average net prices. No significant upward price pressure is expected for the standard oral tablet formulation.
- Impact of Policy Changes: Potential changes in US drug pricing regulations or Medicare Part D policies could indirectly influence generic drug pricing dynamics, but direct impacts on established generics like lisinopril are less predictable.
- Emergence of New Therapies: While highly effective, lisinopril may face gradual substitution by newer classes of cardiovascular drugs (e.g., ARNI combinations) in specific patient populations. However, its cost-effectiveness ensures its continued use in broad hypertension management.
- NDC 00093-8343 Specifics: As a widely available generic, its price will track the overall market trend for lisinopril, rather than being driven by unique patent lifecycles or R&D pipeline events.
What are the Regulatory and Compliance Considerations?
The manufacturing and sale of lisinopril tablets are subject to stringent regulatory oversight by agencies like the U.S. Food and Drug Administration (FDA).
- Good Manufacturing Practices (GMP): All manufacturers must adhere to cGMP guidelines to ensure product quality, safety, and efficacy.
- FDA Inspections: Facilities are subject to regular FDA inspections.
- ANDA Approval: Generic manufacturers must obtain an Abbreviated New Drug Application (ANDA) approval from the FDA, demonstrating bioequivalence to the reference listed drug.
- NDC Coding: The National Drug Code (NDC) system is used for unique identification of drug products within the US. NDC 00093-8343 signifies a specific product's manufacturer, formulation, and packaging.
- Labeling and Packaging: Strict requirements for product labeling, including dosage, warnings, and expiration dates.
Key Takeaways
- NDC 00093-8343 represents a generic lisinopril tablet, a mature drug with a stable and substantial market share within the ACE inhibitor class.
- The market is characterized by intense generic competition, leading to low wholesale and net prices.
- Original patents for lisinopril have long expired, precluding any new drug exclusivity.
- Price projections indicate continued stability with slight downward pressure due to ongoing competition.
- Regulatory compliance with GMP and FDA guidelines is critical for all manufacturers.
Frequently Asked Questions
What is the primary indication for NDC 00093-8343?
NDC 00093-8343 is a formulation of lisinopril, indicated for the treatment of hypertension (high blood pressure) and heart failure.
What is the typical dosage range for lisinopril?
Lisinopril dosages vary, but common starting doses for hypertension are 10 mg once daily, with titration up to 40 mg once daily. For heart failure, dosages can range from 5 mg to 40 mg once daily.
How does the price of NDC 00093-8343 compare to other lisinopril generics?
The price of NDC 00093-8343, associated with Merck & Co., will generally fall within the competitive range of other generic lisinopril offerings. While specific contract pricing can cause minor variations, the overall price point is dictated by broad market competition.
Are there any upcoming patent expirations relevant to lisinopril that could impact NDC 00093-8343?
No, as lisinopril is a well-established generic, its primary composition of matter patents expired decades ago. There are no new drug patent expirations anticipated that would directly affect the generic market for standard lisinopril tablets.
What factors could cause significant price increases for lisinopril tablets in the future?
Significant price increases for lisinopril tablets are unlikely due to the mature generic market. Potential, albeit improbable, factors could include widespread API supply chain disruptions or a drastic reduction in the number of generic manufacturers, neither of which is currently projected.
What is the difference between NDC 00093-8343 and other NDC codes for lisinopril?
Different NDC codes represent variations in manufacturer, strength, dosage form (e.g., tablet, oral solution), and package size. NDC 00093-8343 specifically identifies a lisinopril product from a particular manufacturer (Merck & Co. for the associated branded generic) with a specific presentation.
How does bioequivalence testing impact generic drug pricing?
Bioequivalence testing ensures that generic drugs perform the same as their brand-name counterparts. Successful bioequivalence demonstration allows for regulatory approval of generics, which then compete on price, driving down overall costs for the medication.
Cited Sources
[1] Global ACE Inhibitor Market Analysis Report. (2024). Market Research Future. (Hypothetical source for illustration; actual market reports should be cited.)
[2] Cardiovascular Drug Market Overview. (2023). IQVIA Institute for Human Data Science. (Hypothetical source for illustration; actual market reports should be cited.)
[3] U.S. Prescription Data Analysis for Lisinopril. (2023). Symphony Health Solutions. (Hypothetical source for illustration; actual market data providers should be cited.)
[4] Generic Drug Pricing Index. (2024). First Databank (FDB) / Red Book. (Hypothetical source for illustration; actual pricing databases should be cited.)
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