Last updated: February 19, 2026
This report analyzes the market landscape and projects price trends for the drug identified by NDC 00378-0896. The analysis incorporates patent status, market competition, and reimbursement policies to forecast future pricing.
What is NDC 00378-0896?
NDC 00378-0896 is the National Drug Code assigned to Lisinopril tablets, 10 mg, manufactured by Alembic Pharmaceuticals Inc. Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure (hypertension) and heart failure. It is also used after a heart attack to reduce the risk of death.
Patent Landscape and Exclusivity
The original patents for lisinopril have long expired, allowing for generic competition. Lisinopril was first approved by the U.S. Food and Drug Administration (FDA) in 1987. This extended period of patent expiry means that the drug has been available as a generic for several decades.
- Original Patents: Expired.
- Exclusivity Periods: No market exclusivity is currently held for the active pharmaceutical ingredient (API) or the specific formulation of lisinopril 10 mg tablets.
- Regulatory Approvals: Multiple generic manufacturers have received FDA approval to market lisinopril products, including Alembic Pharmaceuticals Inc.
Market Competition for Lisinopril 10 mg Tablets
The market for lisinopril 10 mg tablets is highly competitive, characterized by numerous generic manufacturers. This intense competition significantly influences pricing dynamics.
Key Market Participants
- Alembic Pharmaceuticals Inc.: The manufacturer of the specific NDC 00378-0896 product.
- Teva Pharmaceuticals USA, Inc.: A major player in the generic pharmaceutical market, offering lisinopril products.
- Apotex Corp.: Another significant generic drug manufacturer with lisinopril offerings.
- Dr. Reddy's Laboratories: A global pharmaceutical company that manufactures generic lisinopril.
- Major Retailers and Wholesalers: Companies such as CVS Pharmacy, Walgreens, Walmart, McKesson, and Cardinal Health distribute generic lisinopril from various manufacturers.
The presence of these diverse manufacturers, coupled with established supply chains, creates a saturated market.
Market Share and Volume
While precise, up-to-the-minute market share data for specific NDCs is proprietary, lisinopril as a class is one of the most prescribed medications in the United States. According to IQVIA data, lisinopril has consistently ranked among the top dispensed medications for hypertension. The 10 mg dosage is a standard and widely prescribed strength, contributing to high sales volumes.
Pricing Analysis and Factors Influencing Cost
The pricing of generic lisinopril 10 mg tablets is primarily driven by supply and demand, manufacturing costs, and reimbursement policies.
Historical Pricing Trends
Generic drugs, once off-patent, typically experience a significant price drop upon market entry of multiple competitors. Lisinopril has followed this trajectory.
- Initial Generic Entry: Prices for lisinopril fell sharply after the first generic versions became available.
- Sustained Low Pricing: For many years, lisinopril has been available at very low price points due to the high number of generic suppliers.
- Recent Fluctuations: While generally stable, minor price fluctuations can occur due to supply chain disruptions, changes in raw material costs, or the exit or entry of specific manufacturers. However, the overall trend remains one of affordability.
Average Wholesale Price (AWP) and Net Price
The Average Wholesale Price (AWP) is a benchmark pricing figure used by many payers. However, the net price (the actual price paid after rebates and discounts) is often considerably lower.
- AWP for Lisinopril 10 mg (30-count bottle): Typically ranges from $10 to $30, but this is a list price and not the transacted price.
- Net Price: Real-world net prices can be as low as $1 to $5 for a 30-day supply, particularly for cash-paying customers or through large pharmacy benefit manager (PBM) contracts.
Data from generic drug pricing databases like GoodRx or First Databank can provide more granular insights into actual transaction prices at the pharmacy level, often revealing significant variations based on location and specific pharmacy.
Factors Affecting Current Pricing
- Manufacturing Costs: Raw material costs for lisinopril API, manufacturing overhead, and quality control expenses. These costs are generally stable for well-established generics.
- Competition: The large number of generic manufacturers (including Alembic, Teva, Apotex, Dr. Reddy's, and others) creates downward pressure on prices.
- Reimbursement Policies:
- Pharmacy Benefit Managers (PBMs): PBMs negotiate rebates and discounts with manufacturers. Lisinopril is typically on the lowest cost tier of most formularies, meaning it has a low co-pay for patients.
- Medicare Part D and Medicaid: These programs have specific pricing regulations and preferred drug lists that further drive down costs for high-volume generics.
- Cash Prices: While higher than negotiated prices, cash prices for lisinopril are still exceptionally low compared to branded drugs.
- Supply Chain Dynamics: While generally stable, any disruption in API supply or manufacturing capacity from a major producer could temporarily impact availability and slightly increase prices. However, the vast number of alternative suppliers mitigates this risk.
- Inflation: General economic inflation can lead to minor increases in manufacturing and distribution costs, which may be passed on as small price adjustments.
Price Projections for NDC 00378-0896
Based on the current market dynamics, patent status, and competitive landscape, the price projections for lisinopril 10 mg tablets (NDC 00378-0896) are as follows:
Short-Term (1-2 Years)
- Projection: Stable to a slight decrease.
- Rationale: The market is mature and highly competitive. Increased manufacturing efficiencies and ongoing PBM negotiations will likely keep prices low. Minor downward pressure may arise from new entrants or aggressive pricing strategies from existing competitors aiming to maintain market share. Any upward pressure from inflation is expected to be minimal given the commoditized nature of the product.
Medium-Term (3-5 Years)
- Projection: Continued stability with potential for marginal decreases.
- Rationale: Lisinopril is a cornerstone therapy for hypertension, ensuring continued high demand. The absence of new patent expirations or significant therapeutic alternatives entering the market for this specific indication means the competitive environment will persist. Pricing will remain primarily dictated by cost efficiencies and payer negotiations. A slight decrease is possible if further consolidation among manufacturers or advancements in manufacturing technology reduce overall production costs.
Long-Term (5+ Years)
- Projection: High likelihood of continued low pricing, subject to significant shifts in healthcare policy or therapeutic advancements.
- Rationale: Absent any major disruptions, lisinopril is expected to remain a cost-effective, widely prescribed medication. Future price trends will be contingent on broader healthcare policy changes, potential new indications for lisinopril that could impact demand, or the introduction of novel hypertension treatments that significantly displace ACE inhibitors. However, the historical trajectory of such widely adopted generics suggests sustained affordability.
Table 1: Price Projection Summary for Lisinopril 10 mg Tablets (NDC 00378-0896)
| Time Horizon |
Projected Price Trend |
Key Influencing Factors |
| Short-Term (1-2 Years) |
Stable to Slight Decrease |
Intense competition, PBM negotiations, manufacturing costs |
| Medium-Term (3-5 Years) |
Continued Stability, Marginal Decrease |
Sustained demand, ongoing competition, cost efficiencies |
| Long-Term (5+ Years) |
Continued Low Pricing |
Healthcare policy, therapeutic advancements, market maturity |
Key Takeaways
- NDC 00378-0896 is Alembic Pharmaceuticals Inc.'s 10 mg lisinopril tablet, a generic ACE inhibitor.
- The market is characterized by a high degree of competition due to expired patents and numerous generic manufacturers.
- Pricing is extremely competitive, with net prices for a 30-day supply often falling between $1 and $5.
- Projections indicate continued price stability or a slight decrease in the short to medium term, driven by ongoing competition and payer negotiations.
- Long-term pricing is expected to remain low, barring significant shifts in healthcare policy or the emergence of disruptive therapeutic alternatives.
Frequently Asked Questions
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What is the primary driver of the low price for lisinopril 10 mg tablets?
The primary driver is the intense competition among multiple generic manufacturers, coupled with the drug's long history of patent expiry.
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Can I expect significant price increases for lisinopril 10 mg tablets in the next five years?
Significant price increases are unlikely. The market is mature and highly competitive, favoring price stability or minor decreases.
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Does the manufacturer (Alembic Pharmaceuticals Inc.) have any patent protection on this specific product that would affect its price?
No, the original patents for lisinopril have long expired, and there is no current market exclusivity for this generic formulation.
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How do PBMs influence the price of lisinopril 10 mg tablets?
PBMs negotiate rebates and discounts with manufacturers, ensuring that lisinopril is placed on low-cost tiers of insurance formularies, thereby reducing patient co-pays and overall net cost.
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Are there any potential supply chain risks that could significantly impact the price of lisinopril 10 mg tablets?
While widespread supply chain disruptions are always a possibility, the large number of manufacturers producing lisinopril mitigates the risk of a significant price impact. Alternative suppliers can generally fill any production gaps.
Citations
[1] U.S. Food & Drug Administration. (n.d.). FDA National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory/search-national-drug-code-directory
[2] IQVIA. (Data pertaining to prescription volume and market share for cardiovascular drugs). (Specific report details not publicly available for direct citation but information is widely disseminated through industry analysis).
[3] GoodRx. (n.d.). Lisinopril Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/lisinopril
[4] First Databank. (Proprietary drug pricing data). (Access requires subscription).
