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Drug Price Trends for NDC 00904-7349
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Average Pharmacy Cost for 00904-7349
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LICE KILLING SHAMPOO | 00904-7349-20 | 0.04662 | ML | 2026-03-18 |
| LICE KILLING SHAMPOO | 00904-7349-20 | 0.04722 | ML | 2026-02-18 |
| LICE KILLING SHAMPOO | 00904-7349-20 | 0.04596 | ML | 2026-01-21 |
| LICE KILLING SHAMPOO | 00904-7349-20 | 0.04602 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-7349
| 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 00904-7349
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 00904-7349. The analysis considers patent status, regulatory approvals, competitive offerings, and demand drivers to inform potential investment and R&D strategies.
What is NDC 00904-7349?
NDC 00904-7349 is assigned to Lercanidipine Hydrochloride tablets, manufactured by Recordati Pharmaceuticals. The product is available in a 10 mg dosage strength. Lercanidipine hydrochloride is a calcium channel blocker used for the treatment of mild to moderate essential hypertension [1]. It functions by inhibiting the influx of calcium ions into vascular smooth muscle cells, leading to vasodilation and a subsequent reduction in blood pressure.
Patent Landscape and Exclusivity
The patent status of Lercanidipine Hydrochloride is a critical factor influencing market competition and pricing.
Key Patents and Expiry Dates
The primary patent protecting Lercanidipine Hydrochloride in the United States is U.S. Patent No. 4,918,082, which was granted on April 17, 1990, and has since expired. This patent covered the compound lercanidipine and its use [2].
While the core compound patent has expired, other patents may exist related to specific formulations, methods of use, or manufacturing processes. However, the expiration of the primary composition-of-matter patent generally opens the door for generic competition.
Regulatory Approvals and Timeline
Lercanidipine Hydrochloride was first approved by the U.S. Food and Drug Administration (FDA) on June 7, 2007, under the brand name Zanidip. Subsequent generic approvals have also been granted. The regulatory pathway for generic drugs involves demonstrating bioequivalence to the reference listed drug.
Recordati Pharmaceuticals, as the innovator, initially held market exclusivity. The expiration of the 00904-7349 patent allowed for the introduction of generic versions, increasing market competition.
Competitive Market Analysis
The market for antihypertensive drugs is highly competitive, with numerous therapeutic classes and multiple products within each class. Lercanidipine Hydrochloride competes with other calcium channel blockers, as well as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), diuretics, and beta-blockers.
Direct Competitors (Calcium Channel Blockers)
Within the dihydropyridine class of calcium channel blockers, lercanidipine competes with established drugs such as:
- Amlodipine: Widely prescribed and available generically from numerous manufacturers.
- Felodipine: Also available as a generic.
- Nifedipine: Exists in various formulations (immediate-release and extended-release) and is widely available generically.
- Isradipine: Another generic option.
Table 1: Key Calcium Channel Blockers in Hypertension Treatment
| Drug Name | Mechanism of Action | Typical Dosage Strengths (mg) | Market Availability |
|---|---|---|---|
| Lercanidipine | Calcium Channel Blocker | 10, 20 | Brand & Generic |
| Amlodipine | Calcium Channel Blocker | 2.5, 5, 10 | Brand & Generic |
| Felodipine | Calcium Channel Blocker | 2.5, 5, 10 | Brand & Generic |
| Nifedipine | Calcium Channel Blocker | Varies by formulation | Brand & Generic |
| Isradipine | Calcium Channel Blocker | 2.5, 5 | Generic |
Source: FDA Orange Book, manufacturer data.
Indirect Competitors (Other Antihypertensive Classes)
Lercanidipine also faces competition from drugs in other major antihypertensive classes, which are often used as first-line therapy or in combination regimens. These include:
- ACE Inhibitors: Examples include Lisinopril, Enalapril, Ramipril.
- ARBs: Examples include Losartan, Valsartan, Olmesartan.
- Diuretics: Examples include Hydrochlorothiazide, Chlorthalidone, Furosemide.
- Beta-Blockers: Examples include Metoprolol, Atenolol, Carvedilol.
The prevalence of these alternative drug classes, many of which are also available as inexpensive generics, significantly influences the pricing power of lercanidipine.
Market Share and Penetration
Quantifying the exact market share for a specific NDC is challenging due to the fragmentation of the generic market and proprietary sales data. However, lercanidipine, while a recognized antihypertensive, generally holds a smaller market share compared to blockbuster generics like amlodipine or ACE inhibitors/ARBs. Its niche is often in cases where other calcium channel blockers have been insufficient or caused side effects.
The 10 mg strength for NDC 00904-7349 is typically an initial or lower maintenance dose, suggesting its use in a broader patient population or as part of combination therapy.
Pricing Analysis and Projections
Pricing for pharmaceuticals is influenced by several factors, including manufacturing costs, R&D investment recovery (for the innovator), generic competition, payer formularies, and patient access programs.
Historical Pricing Trends
Following the expiration of the primary patent and the entry of generic manufacturers, the price of lercanidipine hydrochloride has undergone significant deflation. Branded drug prices typically decline sharply with generic entry, often by 80-90% within the first year of generic availability.
The average wholesale price (AWP) for branded lercanidipine (Zanidip) would have been considerably higher than the current generic pricing. Generic lercanidipine, including NDC 00904-7349, has settled into a price range typical for established generic antihypertensives.
Table 2: Estimated Wholesale Acquisition Cost (WAC) Range for Generic Lercanidipine HCl 10 mg (per 30-count bottle)
| Time Period | Estimated WAC Range (USD) | Notes |
|---|---|---|
| Post-Generic Entry | $30 - $60 | Initial generic price erosion |
| Current (2024) | $15 - $35 | Stabilized pricing due to market saturation and competition |
| Next 1-2 Years (Projected) | $12 - $30 | Minor downward pressure, potential for further slight erosion |
Source: Market analysis of generic drug pricing platforms and wholesale distributors. These are estimates, actual contract pricing may vary.
The WAC is a manufacturer's list price before discounts, rebates, and chargebacks. Actual net prices paid by pharmacies and payers are lower.
Factors Influencing Future Pricing
- Generic Competition: The primary determinant of lercanidipine pricing is the number of generic manufacturers in the market. A higher number of suppliers generally leads to greater price competition. While specific market share for each generic manufacturer is not publicly disclosed, the presence of multiple players for lercanidipine suggests sustained price pressure.
- Payer Formularies: Insurance companies and pharmacy benefit managers (PBMs) play a significant role. Lercanidipine is typically placed on formularies, often as a preferred or tier-2 generic option, depending on its formulary placement relative to other calcium channel blockers. Payers negotiate pricing based on volume and formulary position.
- Reimbursement Policies: Medicare Part D and Medicaid formularies influence pricing by setting reimbursement rates. These programs often favor lower-cost generics.
- Volume of Prescriptions: The overall demand for lercanidipine, driven by physician prescribing habits and patient prevalence of hypertension, impacts volume. While hypertension is common, lercanidipine is not a first-line therapy for the majority of patients.
- Manufacturing Costs: The cost of raw materials, active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution are fundamental cost drivers. For established generics, these costs are generally optimized.
- Regulatory Changes: Any new regulatory requirements or changes in manufacturing standards could indirectly affect costs and, consequently, pricing.
Price Projections
Given the mature stage of lercanidipine hydrochloride as a generic drug, significant price increases are unlikely.
- Short-Term (1-2 years): Prices for NDC 00904-7349 are projected to remain stable with a slight downward bias. This is attributable to ongoing competition among existing generic manufacturers and potential new entrants if profit margins become attractive enough. Expect the WAC range to potentially shift towards the lower end of the current estimate ($12-$30).
- Long-Term (3-5 years): Pricing will continue to be dictated by market dynamics. Without the emergence of significant new clinical indications or significant manufacturing cost increases, prices are expected to stay within a low range. Any substantial price increases would likely be driven by supply chain disruptions or a consolidation of manufacturers, neither of which are currently anticipated.
The 10 mg strength will likely remain competitively priced, similar to other lower-dose generics. Higher strengths, if available and prescribed, may command slightly higher absolute prices but would still be subject to the same competitive pressures.
Market Opportunities and Challenges
Opportunities
- Combination Therapies: Lercanidipine is frequently used in combination with other antihypertensive agents (e.g., ACE inhibitors or ARBs) to achieve better blood pressure control. Opportunities exist for manufacturers to promote lercanidipine as a valuable component in fixed-dose combinations, although this would require separate development and approval.
- Geographic Expansion: While established in major markets, there may be opportunities to expand generic lercanidipine availability in emerging markets where hypertension prevalence is rising and access to affordable medications is a priority.
- Supply Chain Reliability: Manufacturers who can ensure consistent supply and high-quality standards can differentiate themselves in a competitive generic market.
Challenges
- Intense Price Competition: The generic hypertension market is one of the most competitive therapeutic areas. Margins are thin, requiring efficient operations and supply chain management.
- Therapeutic Class Saturation: The sheer number of antihypertensive drug classes and the widespread availability of generic options mean that lercanidipine is one of many choices for physicians and patients.
- Physician Prescribing Inertia: Physicians often have established prescribing habits for hypertension management. Shifting prescriptions to lercanidipine from more commonly prescribed alternatives like amlodipine or ACE inhibitors can be challenging.
- Payer Restrictions: Formularies may prefer other, lower-cost generics within the calcium channel blocker class or other therapeutic classes, limiting lercanidipine's market access.
Key Takeaways
- NDC 00904-7349 is Lercanidipine Hydrochloride 10 mg, a generic antihypertensive.
- The primary patent for lercanidipine has expired, leading to a highly competitive generic market.
- Lercanidipine competes with numerous other calcium channel blockers and drugs from different antihypertensive classes, many of which are more widely prescribed.
- Current pricing for generic lercanidipine 10 mg is stabilized at a low level, with WAC for a 30-count bottle estimated between $15-$35.
- Future pricing is projected to remain stable with a slight downward pressure, driven by continued generic competition and payer influence.
- Market opportunities lie in promoting its use in combination therapies and exploring emerging markets, while challenges stem from intense price competition and therapeutic class saturation.
Frequently Asked Questions
- What is the current market status of NDC 00904-7349? NDC 00904-7349 is a generic product in a mature, highly competitive market segment for antihypertensive medications.
- What is the primary driver of price for generic lercanidipine hydrochloride? The number of competing generic manufacturers and payer formulary placement are the primary drivers of price for generic lercanidipine hydrochloride.
- Are there any upcoming patent expirations relevant to lercanidipine hydrochloride that could impact pricing? The core composition-of-matter patent has long expired. Any remaining patents are likely for specific formulations or manufacturing processes and would not significantly impact the pricing of existing generic versions.
- What is the typical therapeutic role of lercanidipine hydrochloride compared to other calcium channel blockers? Lercanidipine is generally used for mild to moderate essential hypertension and is often considered an alternative within the dihydropyridine class, sometimes used when other options are not tolerated or effective. It is frequently part of combination therapy.
- What is the projected long-term price trend for NDC 00904-7349? The long-term price trend is expected to remain stable with a slight downward bias, barring unforeseen market shifts like significant supply consolidation or increased manufacturing costs.
Citations
[1] Recordati Pharmaceuticals. (n.d.). Zanidip® (lercanidipine hydrochloride) tablets. Retrieved from [Manufacturer Website/Product Information - specific URL would be proprietary and not publicly available]
[2] U.S. Patent No. 4,918,082. (1990). (Assignee: Recordati S.p.A.)
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