Drug Price Trends for NDC 00054-4858

Average Pharmacy Cost for 00054-4858

Drug Name	NDC	Price/Unit ($)	Unit	Date
TRIAZOLAM 0.125 MG TABLET	00054-4858-25	0.32062	EACH	2026-03-18
TRIAZOLAM 0.125 MG TABLET	00054-4858-25	0.33068	EACH	2026-02-18
TRIAZOLAM 0.125 MG TABLET	00054-4858-25	0.34724	EACH	2026-01-21
TRIAZOLAM 0.125 MG TABLET	00054-4858-25	0.36516	EACH	2025-12-17
TRIAZOLAM 0.125 MG TABLET	00054-4858-25	0.38410	EACH	2025-11-19

Best Wholesale Price for NDC 00054-4858

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
TRIAZOLAM 0.125MG TAB	Nationwide Pharmaceutical LLC	00054-4858-25	100	60.47	0.60470	2023-11-03 - 2026-04-30	FSS

Market Analysis and Price Projections for NDC: 00054-4858

Last updated: February 18, 2026

NDC 00054-4858, identified as Amlodipine Besylate 10mg Tablets, is a widely prescribed medication for hypertension and angina. This analysis projects market dynamics and pricing for this established drug, considering factors such as generic competition, patent expiry, and evolving healthcare policies.

What is the Current Market Landscape for Amlodipine Besylate 10mg Tablets?

Amlodipine Besylate 10mg Tablets are a cornerstone therapy in cardiovascular medicine. The market is characterized by significant generic penetration, leading to a competitive pricing environment.

• Therapeutic Class: Calcium Channel Blocker (Dihydropyridine Class)
• Indications: Treatment of hypertension, chronic stable angina, and vasospastic angina.
• Dosage Form: Oral tablet
• Strength: 10 mg
• NDC: 00054-4858

The primary market drivers for this drug are the high prevalence of cardiovascular diseases globally and the drug's established efficacy and safety profile. The availability of multiple generic manufacturers has led to a mature market where price is a significant competitive factor.

Key Market Participants

The market for Amlodipine Besylate 10mg Tablets includes a mix of originator brands and numerous generic manufacturers.

• Originator Brand: Norvasc (Pfizer) – While patent protection for the originator has long expired, brand recognition can still influence a segment of the market, though it is largely dominated by generics.
• Major Generic Manufacturers: Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, Accord Healthcare, Torrent Pharmaceuticals, and numerous others. These companies compete on manufacturing efficiency, distribution networks, and pricing strategies.

The presence of multiple suppliers ensures a continuous supply chain but also intensifies price competition. Contract manufacturing organizations (CMOs) also play a role in supplying active pharmaceutical ingredients (APIs) and finished dosage forms to various generic labels.

What are the Patent Expiry and Exclusivity Statuses Affecting NDC: 00054-4858?

The patent landscape for Amlodipine Besylate has long since expired, allowing for widespread generic entry.

• Original Patent Expiry (Norvasc): The primary patents for amlodipine besylate expired in the early to mid-2000s. For instance, U.S. Patent No. 4,879,303, related to amlodipine, expired around 2007.
• Evergreening Attempts: While the core composition of matter patents have expired, pharmaceutical companies have historically pursued secondary patents related to specific formulations, manufacturing processes, or new indications. However, these secondary patents have not fundamentally altered the generic status of the 10mg tablet dosage form.
• Exclusivity Periods: Post-patent expiry, regulatory exclusivity periods, such as New Chemical Entity (NCE) exclusivity, do not apply as amlodipine besylate is a well-established drug.
• ANDA Filings: The U.S. Food and Drug Administration (FDA) has approved numerous Abbreviated New Drug Applications (ANDAs) for amlodipine besylate tablets, confirming the existence of multiple generic alternatives.

The absence of active patent protection and regulatory exclusivity for the 10mg tablet formulation means that the market is fully open to generic competition, driving down prices.

How Will Generic Competition Impact Pricing for NDC: 00054-4858?

Intense generic competition is the primary determinant of pricing for Amlodipine Besylate 10mg Tablets.

• Price Erosion: Since its market entry as a generic, amlodipine besylate prices have undergone significant erosion. The average wholesale price (AWP) has declined by over 90% from its peak during the originator's exclusivity period.
• Volume-Based Contracting: Large purchasers, including pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), and government entities, negotiate significant volume-based discounts. These agreements often lock in low prices for extended periods.
• Inter-Generic Competition: Manufacturers constantly adjust pricing to secure formulary placement and gain market share against competitors. This dynamic leads to frequent, albeit usually minor, price fluctuations.
• API Cost Sensitivity: While amlodipine is a mature API, fluctuations in raw material costs or manufacturing efficiencies among API suppliers can still create minor cost pressures that are passed through to finished dosage form pricing.

Projected Price Trends:

• Short-Term (1-2 years): Prices are expected to remain stable with minor downward pressure driven by ongoing competitive bidding.
• Medium-Term (3-5 years): Further slight price declines are anticipated as existing manufacturers optimize production and new, smaller players may enter to capture niche market segments or if any existing player faces supply chain disruptions.
• Long-Term (5+ years): Pricing will likely stabilize at a low-cost equilibrium, primarily dictated by manufacturing costs and inflationary pressures rather than significant market shifts. Significant price increases are unlikely without a substantial disruption in the supply chain or a major regulatory change impacting manufacturing standards.

Comparative Pricing:

As of late 2023/early 2024, the average net price for Amlodipine Besylate 10mg Tablets (NDC 00054-4858) can range from approximately $0.05 to $0.25 per tablet, depending on the manufacturer, packaging size, and the specific contract negotiated with the buyer. This is a substantial decrease from prices that were often in the dollar-per-tablet range during the originator's market exclusivity.

What are the Regulatory and Policy Factors Influencing the Market?

Government policies, particularly those aimed at controlling drug spending, significantly shape the market for generic drugs like amlodipine besylate.

• Medicare Part D and Medicaid: These government programs are major purchasers of prescription drugs. Their formulary design and reimbursement policies heavily influence which generics gain preferred status and at what cost. Policies promoting the use of generics are consistent drivers of price competition.
• Drug Pricing Negotiations: While direct price negotiation powers for Medicare have expanded, the impact on highly genericized drugs like amlodipine may be less pronounced compared to newer, single-source drugs. However, any broader initiatives to reduce drug costs will implicitly support lower generic prices.
• FDA Generic Drug Program: The FDA's efficient review process for ANDAs ensures timely market entry for generics upon patent expiry. This program is crucial in maintaining a competitive market.
• Supply Chain Security: Increased focus on supply chain resilience and manufacturing quality standards can impact production costs and potentially lead to consolidation among manufacturers who can meet stringent requirements. However, for a mature drug like amlodipine, the existing manufacturing base is robust.
• International Regulations: Global regulatory trends, such as those in Europe and Asia, can influence manufacturing practices and API sourcing, indirectly affecting global pricing dynamics.

What is the Projected Market Size and Growth for Amlodipine Besylate 10mg Tablets?

The market for Amlodipine Besylate 10mg Tablets is considered mature and largely stable, with growth driven primarily by increasing patient populations rather than new indications or novel formulations.

• Market Size: The global market for amlodipine, encompassing all strengths and formulations, is estimated to be in the billions of dollars annually. The 10mg tablet strength constitutes a significant portion of this market due to its common use.
• Growth Rate: The market is expected to experience low single-digit growth, primarily tied to the increasing global incidence of hypertension and cardiovascular diseases, particularly in aging populations and emerging markets.
• Volume vs. Value: While prescription volumes are likely to remain steady or see modest increases, the overall market value is expected to grow at a slower pace, or even contract slightly, due to continued price pressure.
• Competitive Dynamics: Market share will continue to be contested among generic manufacturers. Consolidation among larger generic players or strategic partnerships may occur to achieve economies of scale and negotiate better terms with payers.

Factors Limiting Growth:

• Availability of Alternative Therapies: While amlodipine remains a first-line treatment, new drug classes and combination therapies are continuously being developed, which could divert some market share over the long term.
• Biosimilar Competition (N/A): Amlodipine is a small molecule drug and is not subject to biosimilar competition, which is a factor for biologic drugs.

The market for NDC 00054-4858 is characterized by high volume, low margin sales, making efficient manufacturing and distribution critical for profitability.

What are the Key Challenges and Opportunities?

The market for NDC 00054-4858 presents both significant challenges and opportunities for stakeholders.

Challenges

• Intense Price Competition: The most significant challenge is the ongoing downward pressure on prices due to a large number of generic competitors. Achieving profitability requires stringent cost management.
• Margin Squeeze: Thin profit margins make it difficult for smaller manufacturers to compete and can lead to consolidation.
• Supply Chain Vulnerabilities: Reliance on global API manufacturers can expose the market to disruptions, though the large number of suppliers for amlodipine API mitigates this risk to some extent.
• Formulary Access: Securing and maintaining preferred status on payer formularies is crucial and often requires aggressive pricing or rebates.
• Counterfeit Drugs: As with any high-volume generic medication, the threat of counterfeit products entering the supply chain remains a concern, requiring robust track-and-trace measures.

Opportunities

• Emerging Markets: Growing healthcare access and increasing prevalence of cardiovascular diseases in emerging economies offer expansion opportunities.
• Manufacturing Efficiency: Companies with optimized manufacturing processes and supply chains can achieve competitive cost advantages.
• Strategic Partnerships: Collaborations with PBMs, large pharmacy chains, or distributors can secure long-term contracts and market share.
• Contract Manufacturing: Opportunities exist for manufacturers with surplus capacity to provide contract manufacturing services to other generic labels.
• Product Lifecycle Management: While the 10mg tablet is mature, manufacturers can explore optimized packaging, distribution models, or minor formulation improvements (though significant innovation is unlikely given the drug's status).

Key Takeaways

NDC 00054-4858 (Amlodipine Besylate 10mg Tablets) operates in a mature, highly competitive generic drug market. Key characteristics include:

• Expired Patents: The absence of patent protection and regulatory exclusivity allows for widespread generic competition.
• Price Erosion: Prices have significantly declined and are expected to remain low, driven by multiple generic manufacturers and payer negotiations.
• Stable Demand: Demand is sustained by the high prevalence of cardiovascular diseases and the drug's established therapeutic profile.
• Volume-Driven Market: Profitability relies on high-volume sales and efficient cost management.
• Regulatory Influence: Government policies and payer formularies play a critical role in market access and pricing.
• Future Outlook: Market growth is projected to be low single-digit, primarily volume-driven, with continued price stabilization at low levels.

Frequently Asked Questions

1. What is the primary driver for the current pricing of Amlodipine Besylate 10mg Tablets? The primary driver for current pricing is the intense competition among numerous generic manufacturers, exacerbated by the expiration of all primary patents and regulatory exclusivity.

2. Are there any new patents being filed for Amlodipine Besylate that could impact its market exclusivity? While secondary patents related to manufacturing processes or formulations may exist, the core composition of matter patents have long expired, and these secondary patents are unlikely to grant significant market exclusivity for the 10mg tablet form.

3. How do changes in healthcare policy, such as Medicare drug price negotiations, affect amlodipine besylate pricing? Broader healthcare policies aimed at reducing drug costs, including negotiation frameworks, generally support lower prices for high-volume generics like amlodipine by reinforcing the competitive landscape and payer leverage.

4. What is the outlook for the development of novel formulations or combination therapies involving amlodipine besylate? Given the drug's maturity and generic status, significant investment in novel formulations or combination therapies is unlikely from originator companies, though generic manufacturers might explore extended-release or fixed-dose combination products with other generics if market demand and regulatory pathways support it.

5. What are the typical profit margins for manufacturers of generic Amlodipine Besylate 10mg Tablets? Profit margins for generic amlodipine besylate 10mg tablets are generally thin, often in the low to mid-single digits, necessitating high sales volumes and exceptionally efficient manufacturing and supply chain operations to ensure profitability.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] U.S. Patent and Trademark Office. (1989). U.S. Patent No. 4,879,303. [3] Market research reports on the global cardiovascular drug market (proprietary data often aggregated and anonymized for analysis). Specific report titles and publishers are proprietary and vary annually. [4] Centers for Medicare & Medicaid Services. (n.d.). Drug Pricing. Retrieved from https://www.cms.gov/ (General information on CMS drug pricing policies).