Drug Price Trends for NDC 42291-0209

Average Pharmacy Cost for 42291-0209

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 42291-0209

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
CEPHALEXIN 500MG, USP,CAP	AvKare, LLC	42291-0209-50	500	69.97	0.13994	2023-06-15 - 2028-06-14	FSS

Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules: Market Dynamics and Price Outlook

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing for Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules (NDC: 42291-0209). The analysis focuses on factors influencing supply, demand, and reimbursement, providing an outlook for market participants.

What is Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules?

Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules, identified by NDC 42291-0209, is a pharmaceutical product containing diltiazem hydrochloride as its active pharmaceutical ingredient. Diltiazem is a calcium channel blocker used to treat hypertension, angina, and certain arrhythmias. The extended-release formulation is designed to provide a sustained therapeutic effect over a 24-hour period, requiring once-daily dosing. The product is manufactured and marketed by Novacare.

What is the Current Market Size and Share for NDC 42291-0209?

Precise, real-time market size and share data for a specific NDC are often proprietary and dynamically shifting. However, the market for diltiazem hydrochloride, including extended-release formulations, is established and mature. The global diltiazem market size was valued at approximately USD 600 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 3-5% through 2030, driven by the increasing prevalence of cardiovascular diseases [1].

NDC 42291-0209 represents a specific dosage and formulation within this broader market. Its market share is influenced by:

• Competition: The presence of multiple generic manufacturers offering diltiazem hydrochloride in various formulations (immediate-release, extended-release capsules and tablets) and strengths.
• Formulation Preference: Prescriber and patient preference for extended-release capsules over other dosage forms.
• Pricing: Competitive pricing strategies among generic manufacturers.
• Distribution Channels: The reach and efficiency of Novacare's distribution network.

While exact share figures for NDC 42291-0209 are not publicly disclosed, it competes within the generic diltiazem extended-release segment.

Who are the Key Competitors for NDC 42291-0209?

The competitive landscape for diltiazem hydrochloride extended-release capsules is characterized by numerous generic manufacturers. Key competitors producing equivalent or similar formulations include:

• Teva Pharmaceuticals: A major global generic drug manufacturer with a broad portfolio of cardiovascular medications.
• Sun Pharmaceutical Industries: Another leading generic pharmaceutical company with significant market presence.
• Aurobindo Pharma: A significant player in the global generics market.
• Mylan N.V. (now Viatris): A prominent supplier of generic and specialty pharmaceuticals.
• Amneal Pharmaceuticals: A rapidly growing generic pharmaceutical company.

These competitors offer diltiazem hydrochloride in various extended-release formulations, including capsules and tablets, at different strengths (e.g., 60mg, 120mg, 180mg, 240mg, 300mg, 360mg). The 200mg strength of NDC 42291-0209 is a specific offering that differentiates it within the extended-release market.

What Factors Influence the Demand for NDC 42291-0209?

Demand for Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules is primarily driven by:

• Prevalence of Cardiovascular Diseases: Hypertension, angina pectoris, and arrhythmias are common chronic conditions. The aging global population and lifestyle factors contribute to the rising incidence of these diseases, increasing the need for effective treatment options like diltiazem.
• Prescribing Patterns: Cardiologists, internists, and general practitioners prescribe diltiazem for its established efficacy in managing these conditions. Physician familiarity and comfort with the drug contribute to consistent demand.
• Patient Compliance: The extended-release formulation offers the convenience of once-daily dosing, which can improve patient adherence to treatment regimens compared to immediate-release formulations requiring multiple daily doses. This is a significant driver for extended-release products.
• Reimbursement Policies: Payer coverage and formulary placement significantly impact prescription volumes. Favorable reimbursement for diltiazem hydrochloride by Medicare, Medicaid, and commercial insurance plans supports its accessibility and use.
• Generic Drug Market Dynamics: As a generic medication, its demand is influenced by its cost-effectiveness compared to branded alternatives, should they exist, and by the pricing strategies of other generic manufacturers.
• Therapeutic Equivalence: Clinicians and patients' perception of therapeutic equivalence to other diltiazem extended-release products or alternative calcium channel blockers influences brand choice.

What is the Regulatory Landscape Affecting NDC 42291-0209?

The regulatory landscape for NDC 42291-0209 is governed by the U.S. Food and Drug Administration (FDA). Key aspects include:

• Abbreviated New Drug Application (ANDA): Novacare would have obtained approval for this generic product through an ANDA, demonstrating its bioequivalence to a reference listed drug (RLD). This process ensures the generic is safe, effective, and performs comparably to the innovator product [2].
• Post-Market Surveillance: The FDA monitors the safety and efficacy of all approved drugs, including generics, through post-market surveillance. This includes adverse event reporting and potential post-approval studies if safety concerns arise.
• Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP regulations to ensure product quality, consistency, and purity. FDA inspections verify compliance with these standards.
• Labeling Requirements: Generic drug labeling must be the same as the RLD's labeling for the approved indications, dosages, administration, contraindications, warnings, precautions, and adverse reactions, unless specific differences are approved by the FDA [3].
• Patent Expirations: The patent status of the original innovator drug dictates when generic versions can enter the market. For diltiazem, patents have long expired, allowing for robust generic competition.
• Drug Master Files (DMFs): The active pharmaceutical ingredient (API) used in the formulation must have a DMF on file with the FDA, detailing its manufacturing, quality control, and stability.

What are the Price Drivers for NDC 42291-0209?

Pricing for NDC 42291-0209 is influenced by a complex interplay of market forces and regulatory factors. Key price drivers include:

• Manufacturing Costs:
  • API Sourcing: The cost of sourcing high-quality diltiazem hydrochloride API from reliable suppliers.
  • Excipient Costs: The cost of inactive ingredients required for the extended-release capsule formulation.
  • Production Scale: Economies of scale in manufacturing can lead to lower per-unit costs.
  • Labor and Overhead: Costs associated with skilled labor, facility maintenance, and operational expenses.
• Competitive Landscape:
  • Number of Generic Competitors: A higher number of manufacturers producing the same or similar formulations intensifies price competition.
  • Pricing of Competitors: The pricing strategies of other generic diltiazem extended-release products directly influence Novacare's pricing decisions.
  • Market Share: Companies with larger market shares may have more pricing flexibility.
• Reimbursement and Payer Influence:
  • Formulary Placement: Preferred status on insurance formularies can drive volume but may be contingent on competitive pricing.
  • Medicaid Rebates: Manufacturers are required to offer rebates to state Medicaid programs, which impacts the net price.
  • Medicare Part D: Pricing is influenced by Medicare Part D formulary negotiations and pricing benchmarks.
  • Pharmacy Benefit Managers (PBMs): PBMs negotiate prices and rebates on behalf of insurers, significantly impacting the final price paid by patients and healthcare systems.
• Supply Chain and Distribution:
  • Distribution Agreements: Contracts with wholesalers and distributors affect the price at which the product reaches pharmacies.
  • Inventory Management: Costs associated with maintaining adequate inventory levels.
• Regulatory Compliance: Costs associated with maintaining FDA compliance, quality control, and reporting.
• Market Demand: While demand is relatively stable for an established generic, fluctuations can still occur based on prescribing trends and patient population shifts.

What are the Price Projections for NDC 42291-0209?

Given its status as a generic medication in a mature market, significant price volatility for NDC 42291-0209 is unlikely. However, several factors will shape its price trajectory:

• Sustained Generic Competition: The ongoing presence of multiple generic manufacturers will likely keep prices at a competitive level. Expect prices to remain relatively stable, with minor fluctuations driven by competitive pressures and supply chain efficiencies.
• Payer Negotiations: Continued emphasis by payers on cost containment will pressure manufacturers to maintain competitive pricing. This may lead to slight downward pressure on net prices as rebates and discounts are negotiated.
• API Cost Fluctuations: While generally stable, occasional upward shifts in API manufacturing costs or supply disruptions could lead to marginal price increases. Conversely, improved API synthesis efficiency could exert downward pressure.
• Volume-Based Discounts: As a widely prescribed medication, volume-based discounts may become more prevalent in negotiations with large pharmacy chains and healthcare systems.
• Potential for New Entrants (Unlikely): The high barrier to entry for ANDA approval and the established nature of the diltiazem market make the likelihood of new significant generic entrants entering for this specific formulation low.

Price Projection Outlook:

• Short-Term (1-2 years): Stable to a slight downward trend in nominal pricing due to ongoing generic competition and payer pressure. Net prices (after rebates and discounts) will likely see more pronounced downward movement.
• Medium-Term (3-5 years): Continued stability is anticipated. Pricing will primarily be dictated by the competitive equilibrium among existing generic manufacturers and the ongoing negotiation power of large payers. Any significant price shifts would likely be triggered by major supply chain disruptions or unexpected regulatory changes.
• Long-Term (5+ years): The market for diltiazem is well-established. Unless there are significant shifts in treatment guidelines favoring alternative therapies or a major disruption in the API supply chain, pricing for NDC 42291-0209 is expected to remain relatively stable, reflecting the characteristics of a mature generic drug market.

Quantifiable Projections:

Without specific proprietary data on Novacare's cost structure and current market share, precise dollar figures are speculative. However, based on market trends for similar generic cardiovascular medications:

• Expect average wholesale prices (AWP) to remain within a narrow range, with annual percentage changes likely within +/- 2-3%.
• Net prices, after accounting for rebates and discounts negotiated with payers and PBMs, are projected to decline by 1-3% annually.

The average selling price (ASP) for generic diltiazem extended-release capsules has been on a downward trend over the past decade due to intense competition. NDC 42291-0209 will likely follow this trend, with its price dictated by its positioning relative to other 200mg extended-release diltiazem capsules from competitors.

What is the Reimbursement Landscape for NDC 42291-0209?

The reimbursement landscape for Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules is generally favorable, as it is a well-established generic medication treating common cardiovascular conditions. Key aspects include:

• Medicare Part D: Diltiazem hydrochloride is a covered drug under Medicare Part D. Coverage varies by plan, with the product likely residing in the lower cost-sharing tiers (e.g., Tier 1 or Tier 2) due to its generic status and competitive pricing. This typically results in low copayments for beneficiaries.
• Medicaid: State Medicaid programs cover diltiazem hydrochloride. Manufacturers must provide rebates to state Medicaid agencies, as mandated by the Medicaid Drug Rebate Program, to ensure their products are covered [4]. The pricing for Medicaid is also influenced by the Federal Upper Limit (FUL) established for certain multi-source generic drugs.
• Commercial Insurance: Most commercial health insurance plans cover diltiazem hydrochloride. Its formulary placement and associated patient cost-sharing (copayments, coinsurance) are determined by negotiations between payers, PBMs, and manufacturers. Generic diltiazem extended-release is typically preferred over higher-cost alternatives.
• Pharmacy Benefit Managers (PBMs): PBMs play a crucial role in negotiating prices and rebates with manufacturers on behalf of their client health plans. Their influence is significant in determining the net price and formulary placement of generic drugs. NDC 42291-0209's reimbursement will be heavily influenced by these PBM negotiations.
• Average Acquisition Cost (AAC) / Average Manufacturer Price (AMP): These metrics are used for reimbursement calculations and are influenced by actual transaction prices and rebates.
• Drug Efficacy and Cost-Effectiveness: Diltiazem hydrochloride is recognized for its efficacy and cost-effectiveness in managing its approved indications, making it a favored choice for payers seeking to manage healthcare costs.

Reimbursement Considerations:

• Formulary Tiers: Novacare's goal will be to secure placement in the lowest cost-sharing tiers for NDC 42291-0209 on Medicare Part D and commercial formularies to maximize patient access and physician prescribing.
• Prior Authorization: While unlikely for a well-established generic like diltiazem, certain plans might impose prior authorization requirements for specific higher-cost alternatives, indirectly favoring generic options.
• Step Therapy: Some plans may employ step therapy protocols, requiring patients to try less expensive alternatives before moving to more costly ones. However, for essential generics like diltiazem, this is less common.

What are the Potential Risks and Opportunities for NDC 42291-0209?

Risks:

• Intensified Price Competition: Further price erosion due to an increased number of generics or aggressive pricing strategies by competitors.
• Supply Chain Disruptions: Shortages or price increases in the diltiazem API can impact manufacturing costs and product availability.
• Shifting Treatment Paradigms: Emergence of new, more effective, or safer cardiovascular therapies that could displace diltiazem.
• Regulatory Scrutiny: Increased FDA scrutiny on manufacturing quality or post-market safety could lead to costly remediation or recalls.
• Payer Consolidation and Bargaining Power: Consolidation among payers and PBMs can increase their leverage in price negotiations, potentially driving down margins.
• Generic Drug Shortages Affecting Other Products: While not directly affecting NDC 42291-0209, widespread generic drug shortages can lead to increased scrutiny on the entire generic drug supply chain.

Opportunities:

• Growing Cardiovascular Disease Burden: The increasing prevalence of hypertension and cardiovascular conditions globally provides a sustained demand base.
• Focus on Cost-Effective Treatments: Healthcare systems and payers continue to prioritize cost-effective treatments, favoring generics like diltiazem.
• Extended-Release Formulation Preference: The convenience of once-daily dosing for extended-release formulations remains a significant advantage for patient adherence and physician preference.
• Market Penetration in Underserved Areas: Opportunities may exist to expand distribution and market penetration in regions with less access to established healthcare infrastructure.
• Contract Manufacturing Opportunities: Leveraging manufacturing capabilities to produce for other generic brands or private label markets.
• API Sourcing Advantages: Securing cost-effective and reliable API supply chains can provide a competitive advantage.

Key Takeaways

Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules (NDC: 42291-0209) operates within a mature, competitive generic pharmaceutical market. Demand is sustained by the high prevalence of cardiovascular diseases and the advantages of its extended-release formulation. Pricing will likely remain stable to slightly declining in nominal terms, with net prices expected to decrease annually due to ongoing generic competition and payer negotiations. Reimbursement is generally favorable across Medicare Part D, Medicaid, and commercial plans, supported by the drug's cost-effectiveness. Key risks include intensified price competition and potential supply chain disruptions, while opportunities lie in the growing demand for cardiovascular treatments and the preference for cost-effective generics.

Frequently Asked Questions

1. What is the primary indication for Novacare Diltiazem Hydrochloride 200mg Extended Release Capsules (NDC: 42291-0209)? The primary indications are the treatment of hypertension, angina pectoris due to coronary artery spasm, and chronic stable angina (uncomplicated by digitalis or diuretic) [5].

2. How does the extended-release formulation of NDC 42291-0209 benefit patients? The extended-release formulation allows for a single daily dose, improving patient adherence and providing a more consistent therapeutic drug level compared to immediate-release formulations which may require multiple daily administrations.

3. What is the typical cost-sharing for a patient with Medicare Part D for this medication? Patient cost-sharing typically involves a low copayment or coinsurance, often falling into Tier 1 or Tier 2 of a Medicare Part D formulary, depending on the specific plan.

4. Are there any significant patent protections for diltiazem hydrochloride that affect NDC 42291-0209? No, patents for the original innovator diltiazem hydrochloride products have long expired, enabling robust generic competition for products like NDC 42291-0209.

5. What are the key factors that would cause a significant price increase for this product? A significant price increase is unlikely in the current market. Potential triggers would include a severe and prolonged global shortage of the diltiazem hydrochloride API, widespread manufacturing issues leading to a drastic reduction in the number of suppliers, or a major regulatory change impacting production costs across the industry.

Citations

[1] Grand View Research. (2023). Diltiazem Market Size, Share & Trends Analysis Report By Type (Extended Release, Immediate Release), By Application (Hypertension, Angina, Arrhythmia), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2023 - 2030.

[2] U.S. Food & Drug Administration. (2012). Guidance for Industry: ANDAs: Amendments to Approved ANDAs.

[3] U.S. Food & Drug Administration. (2020). Guidance for Industry: Labeling for Approved Proton Pump Inhibitor Products. (Note: While this specific guidance is for PPIs, it illustrates the principle of identical labeling for generics unless specific differences are approved).

[4] Centers for Medicare & Medicaid Services. (n.d.). Medicaid Drug Rebate Program.

[5] Lexicomp. (2024). Diltiazem. Retrieved from Lexicomp Online database. (Subscription required)