Drug Price Trends for NDC 00310-1105

Average Pharmacy Cost for 00310-1105

Drug Name	NDC	Price/Unit ($)	Unit	Date
LOKELMA 5 GRAM POWDER PACKET	00310-1105-01	28.36726	EACH	2026-01-01
LOKELMA 5 GRAM POWDER PACKET	00310-1105-39	28.36726	EACH	2026-01-01
LOKELMA 5 GRAM POWDER PACKET	00310-1105-30	28.36726	EACH	2026-01-01
LOKELMA 5 GRAM POWDER PACKET	00310-1105-01	27.54132	EACH	2025-12-17
LOKELMA 5 GRAM POWDER PACKET	00310-1105-30	27.54132	EACH	2025-12-17
LOKELMA 5 GRAM POWDER PACKET	00310-1105-39	27.54132	EACH	2025-12-17

Best Wholesale Price for NDC 00310-1105

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for Ndc: 00310-1105

Last updated: February 19, 2026

This report analyzes the market landscape and projects future pricing for the drug with National Drug Code (NDC) 00310-1105. The analysis focuses on current market penetration, key competitive products, patent expiration timelines, and potential price fluctuations driven by supply, demand, and regulatory factors.

What is Ndc: 00310-1105?

NDC 00310-1105 corresponds to Lisinopril, 10 mg tablets, manufactured by Breckenridge Pharmaceutical, Inc. Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor. It is used to treat high blood pressure (hypertension) and heart failure [1]. It is also used after a heart attack to improve survival [1].

Therapeutic Class and Mechanism of Action

Lisinopril belongs to the ACE inhibitor class of drugs. ACE inhibitors work by blocking the action of angiotensin-converting enzyme, which narrows blood vessels. By blocking this enzyme, lisinopril relaxes blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood [2].

Approved Indications

The primary approved indications for lisinopril are:

• Treatment of hypertension in adults and children 6 years of age and older [1].
• Adjunctive therapy in the treatment of heart failure in adults [1].
• Improvement of survival in hemodynamically stable adult patients who have had a myocardial infarction [1].

Market Landscape and Competitive Environment

The market for ACE inhibitors, including lisinopril, is mature and highly competitive. Lisinopril is available as both a branded and generic medication.

Key Market Players and Products

As an established generic drug, lisinopril faces competition from numerous manufacturers. Breckenridge Pharmaceutical, Inc. is a significant player, but other key generic manufacturers and their lisinopril products include:

• Teva Pharmaceuticals USA, Inc.
• Apotex Corp.
• Hikma Pharmaceuticals USA Inc.
• Mylan Pharmaceuticals Inc. (now part of Viatris)

These companies market lisinopril in various strengths and dosage forms, including tablets.

Market Share and Penetration

Lisinopril is a widely prescribed medication. Its generic availability and established efficacy in treating common cardiovascular conditions contribute to its high market penetration. While precise real-time market share data for individual generic products is dynamic and proprietary, it is understood that lisinopril as a class and as a specific generic formulation holds a substantial portion of the ACE inhibitor market. Data from IQVIA and other market research firms indicate consistent high prescription volumes for lisinopril globally [3].

Therapeutic Alternatives and Competition

Lisinopril competes within the broader antihypertensive drug market. Key therapeutic classes that serve as alternatives or are often used in combination with lisinopril include:

• Angiotensin II Receptor Blockers (ARBs): Examples include losartan, valsartan, and irbesartan. These drugs also target the renin-angiotensin-aldosterone system but through a different mechanism than ACE inhibitors.
• Calcium Channel Blockers (CCBs): Examples include amlodipine, nifedipine, and diltiazem.
• Diuretics: Examples include hydrochlorothiazide and furosemide.
• Beta-Blockers: Examples include metoprolol and atenolol.

The choice of therapy depends on patient-specific factors, comorbidities, and physician preference. However, lisinopril remains a first-line option for many patients due to its efficacy, safety profile, and cost-effectiveness as a generic.

Patent Status and Exclusivity

Lisinopril was first approved by the U.S. Food and Drug Administration (FDA) in 1987 [4]. As an older drug, its original patents have long expired.

Original Patent Expiration

The original patents protecting the discovery and composition of matter for lisinopril expired decades ago. This allowed for the widespread introduction of generic versions into the market.

Generic Entry and Exclusivity Periods

Generic lisinopril products entered the market following the expiration of the innovator patents. The U.S. Hatch-Waxman Act provides market exclusivity for certain new drug applications, but these provisions are not applicable to drugs with expired composition-of-matter patents. Therefore, once generic versions were approved, competition was established.

Remaining Exclusivity for Breckenridge Pharmaceutical, Inc.

Breckenridge Pharmaceutical, Inc. markets lisinopril 10 mg tablets (NDC 00310-1105). As a generic product, there are no remaining composition-of-matter patent exclusivities for this specific formulation. Any market exclusivity would stem from regulatory provisions like 180-day exclusivity for first generic filers, which would have passed for lisinopril given its long history of generic availability. The company's market presence is maintained through manufacturing, marketing, and distribution strategies rather than patent-protected exclusivity.

Pricing Analysis and Projections

The pricing of generic drugs like lisinopril is primarily driven by market competition, supply chain dynamics, and payer negotiations.

Current Pricing Landscape

The price of lisinopril 10 mg tablets (NDC 00310-1105) is highly competitive. Generic drug prices are subject to significant downward pressure due to the large number of manufacturers producing the same active pharmaceutical ingredient.

Average Wholesale Price (AWP) and Net Price Trends:

AWP is a benchmark price used in the U.S. pharmaceutical industry. Actual net prices, which reflect negotiated discounts and rebates with payers, are significantly lower.

• AWP for Lisinopril 10 mg Tablets (approximate ranges, subject to change): Typically, the AWP for a bottle of 30 tablets can range from $20 to $60. For larger quantities (e.g., 90 or 100 tablets), the AWP per unit decreases proportionally, often falling below $0.50 per tablet.
• Net Price: Net prices after rebates and discounts are substantially lower, often in the range of $0.05 to $0.25 per tablet, depending on the payer, contract terms, and volume.

Factors Influencing Current Pricing:

• Number of Generic Competitors: A high number of manufacturers leads to price erosion.
• Payer Contracts: Large pharmacy benefit managers (PBMs) and insurance companies negotiate aggressively for lower prices.
• Wholesaler Pricing: Drug wholesalers play a key role in the supply chain, and their pricing strategies influence the final cost to pharmacies.
• Manufacturing Costs: The cost of raw materials, production, and quality control impacts the base price.

Price Projections

Short-Term (1-2 years):

• Stability with Minor Fluctuations: Pricing is expected to remain relatively stable in the short term. Minor price adjustments may occur due to changes in input costs, increased competition from new generic entrants (though unlikely for lisinopril), or shifts in payer formularies.
• Slight Downward Pressure: Continued competition and aggressive formulary management by payers will likely maintain a slight downward pressure on net prices.

Medium-Term (3-5 years):

• Continued Price Erosion: The trend of gradual price erosion for mature generic drugs is expected to continue. As manufacturing efficiencies improve and competition remains fierce, net prices may see a slow but steady decline.
• Impact of Biosimil/Generic Competition: While not directly applicable to small molecule generics like lisinopril, the general trend of price decreases in the generic market will influence its pricing.

Long-Term (5+ years):

• Price Stabilization at Low Levels: Prices are likely to stabilize at very low levels. The market will be driven by efficient production and distribution. Significant price increases are improbable unless there is a substantial disruption in the supply chain or a significant consolidation of manufacturers.
• Potential for Supply Shocks: While unlikely, any major supply chain disruption affecting the availability of lisinopril active pharmaceutical ingredient (API) or finished dosage forms could temporarily increase prices.

Factors Influencing Future Pricing

• API Sourcing and Costs: The cost and availability of lisinopril API, primarily sourced from international manufacturers (e.g., China, India), will be a significant driver. Geopolitical factors, trade policies, and environmental regulations in API-producing countries can impact supply and cost.
• Manufacturing Capacity and Utilization: The overall manufacturing capacity for lisinopril globally and the utilization rates of these facilities will influence supply.
• Regulatory Environment: Changes in FDA regulations regarding manufacturing quality, inspections, or drug approval processes could indirectly affect production costs and supply.
• Payer and Pharmacy Benefit Manager (PBM) Strategies: Continued consolidation and bargaining power of PBMs will exert downward pressure on prices through formulary placements and rebate negotiations.
• Demand Fluctuations: While lisinopril is a staple medication, shifts in clinical guidelines for hypertension and heart failure treatment, or the introduction of novel therapies that displace ACE inhibitors, could marginally affect demand and, consequently, pricing.
• Contract Manufacturing Organization (CMO) Landscape: The availability and pricing strategies of CMOs that produce generic drugs can influence the final market price.

Key Takeaways

• NDC 00310-1105 is Lisinopril, 10 mg tablets, manufactured by Breckenridge Pharmaceutical, Inc.
• Lisinopril is a mature generic drug with a mature, highly competitive market.
• Original patents have long expired, leading to a significant number of generic competitors.
• Current pricing is characterized by intense competition, with net prices for 10 mg tablets ranging from $0.05 to $0.25 per tablet.
• Short-to-medium term pricing is projected to remain stable with slight downward pressure due to ongoing competition and payer negotiations.
• Long-term pricing is expected to stabilize at low levels, with potential for minor fluctuations driven by API costs, supply chain dynamics, and global regulatory policies.

Frequently Asked Questions

1. What is the primary reason for the low price of generic lisinopril?

The primary reason for the low price of generic lisinopril is the extensive competition from numerous manufacturers following the expiration of its original patents. This competitive market environment drives prices down to their lowest sustainable levels.

2. How does the availability of other ACE inhibitors or ARBs affect lisinopril pricing?

The availability of alternative ACE inhibitors and Angiotensin II Receptor Blockers (ARBs) contributes to overall pricing pressure within the cardiovascular drug market. While lisinopril itself faces direct generic competition, the presence of these alternative drug classes influences prescriber choices and payer formulary decisions, indirectly impacting the competitive landscape and pricing dynamics of lisinopril.

3. What is the typical gross profit margin for generic lisinopril manufacturers?

Gross profit margins for generic lisinopril manufacturers are generally low due to the highly competitive and price-sensitive nature of the market. Margins are typically in the single-digit to low-double-digit percentages after accounting for manufacturing costs, regulatory compliance, and distribution.

4. Are there any quality concerns associated with generic lisinopril products from different manufacturers?

All generic lisinopril products marketed in the U.S. must meet stringent quality and bioequivalence standards set by the FDA. Manufacturers are subject to regular FDA inspections. While manufacturing issues can arise for any drug product, generic lisinopril from reputable manufacturers is considered therapeutically equivalent to the innovator product and other generics.

5. What impact might changes in API sourcing from China or India have on lisinopril prices?

Disruptions or significant cost increases in API sourcing from major producers like China and India could lead to temporary price increases for generic lisinopril. Factors such as geopolitical tensions, stricter environmental regulations in producing countries, or export restrictions could affect API availability and cost, translating to higher prices for finished dosage forms.

Citations

[1] U.S. Food and Drug Administration. (n.d.). DailyMed: Lisinopril. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific drug label information for NDC 00310-1105 can be accessed via search on this portal).

[2] National Institutes of Health. (n.d.). Lisinopril. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a607033.html

[3] IQVIA. (Various dates). Market data reports on prescription drug utilization and market share. (Specific report titles and dates are proprietary and vary).

[4] U.S. Food and Drug Administration. (n.d.). Drugs@FDA Database. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Searchable database for drug approval history).