Drug Price Trends for NDC 69584-0091

Average Pharmacy Cost for 69584-0091

Drug Name	NDC	Price/Unit ($)	Unit	Date
BUSPIRONE HCL 5 MG TABLET	69584-0091-10	0.02165	EACH	2026-03-18
BUSPIRONE HCL 5 MG TABLET	69584-0091-50	0.02165	EACH	2026-03-18
BUSPIRONE HCL 5 MG TABLET	69584-0091-10	0.02161	EACH	2026-02-18
BUSPIRONE HCL 5 MG TABLET	69584-0091-50	0.02161	EACH	2026-02-18
BUSPIRONE HCL 5 MG TABLET	69584-0091-10	0.02206	EACH	2026-01-21
BUSPIRONE HCL 5 MG TABLET	69584-0091-50	0.02206	EACH	2026-01-21
BUSPIRONE HCL 5 MG TABLET	69584-0091-10	0.02211	EACH	2025-12-17

Best Wholesale Price for NDC 69584-0091

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
BUSPIRONE HCL 5MG TAB	Nationwide Pharmaceutical LLC	69584-0091-10	100	2.51	0.02510	2022-04-25 - 2026-04-30	FSS
BUSPIRONE HCL 5MG TAB	Nationwide Pharmaceutical LLC	69584-0091-50	500	12.24	0.02448	2022-04-15 - 2026-04-30	FSS

Drug NDC 69584-0091: Market Dynamics and Price Forecast

Last updated: February 19, 2026

This analysis examines the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 69584-0091. The product, a prescription drug, faces competition from generics and is subject to evolving reimbursement policies and payer strategies, which will influence its market penetration and price trajectory.

What is NDC 69584-0091?

NDC 69584-0091 is the unique 11-digit identifier for a pharmaceutical product. This code signifies a specific drug formulation, strength, and packaging combination. Understanding the therapeutic class and active pharmaceutical ingredient (API) associated with this NDC is critical for a precise market analysis. Without this specific information, the analysis is based on general market forces affecting branded and generic pharmaceuticals. For the purpose of this report, we assume NDC 69584-0091 represents a branded pharmaceutical product with an established market presence, facing potential or existing generic competition.

Therapeutic Area and API

The therapeutic area and active pharmaceutical ingredient (API) associated with NDC 69584-0091 determine the drug's patient population, treatment guidelines, and the competitive landscape. For example, a drug in oncology will have different market dynamics than a cardiovascular medication. The API's patent status is a primary driver of market exclusivity for branded products.

Market Exclusivity and Patent Landscape

The patent landscape for the API within NDC 69584-0091 is a crucial determinant of its market exclusivity. Patents grant the innovator company a period of market protection, allowing them to recoup R&D investments.

• Core Patent Expiration: The expiration date of the primary patent covering the API is a key milestone. Generic manufacturers typically prepare to launch their versions upon patent expiration [1].
• Secondary Patents: Additional patents may cover manufacturing processes, specific formulations, or new uses of the API. These can extend market exclusivity beyond the core patent expiration.
• Regulatory Exclusivities: The U.S. Food and Drug Administration (FDA) may grant additional exclusivity periods, such as New Chemical Entity (NCE) exclusivity (5 years) or Orphan Drug exclusivity (7 years), irrespective of patent status [2].

The interplay of patent expiration and regulatory exclusivities defines the window of opportunity for the branded product and the subsequent entry of generic alternatives.

Current Market Position of NDC 69584-0091

The current market position of NDC 69584-0091 is shaped by its clinical utility, physician adoption, payer coverage, and competitive environment.

Prescribing Trends and Physician Adoption

Physician prescribing patterns are influenced by clinical trial data, real-world evidence, physician education, and formulary status.

• Clinical Efficacy: The drug's demonstrated efficacy and safety profile in its approved indications are foundational to physician prescribing. Studies comparing NDC 69584-0091 to existing treatments influence its adoption rate.
• Treatment Guidelines: Inclusion in established clinical practice guidelines by professional organizations elevates a drug's prominence and drives physician prescribing.
• Physician Education and Engagement: Pharmaceutical companies invest in medical science liaisons (MSLs) and sales representatives to educate healthcare providers about the drug's benefits and appropriate use.

Payer Coverage and Reimbursement

Payer decisions, primarily by commercial insurers and government programs like Medicare and Medicaid, significantly impact patient access and, consequently, market share.

• Formulary Placement: A drug's position on a payer's formulary (e.g., preferred, non-preferred, excluded) dictates patient co-pays and the likelihood of prescription.
• Prior Authorization and Step Therapy: Requirements for prior authorization or step therapy (requiring patients to try less expensive alternatives first) can create barriers to access for NDC 69584-0091.
• Rebate and Discount Negotiations: Pharmaceutical manufacturers engage in rebate negotiations with payers to secure favorable formulary placement. These rebates reduce the net price of the drug.

Competitive Landscape

The presence and strength of competitors, including other branded drugs and generics, define the competitive intensity for NDC 69584-0091.

• Direct Competitors: Drugs with similar mechanisms of action and indications.
• Indirect Competitors: Treatments that address the same condition through different therapeutic pathways or non-pharmacological interventions.
• Generic Erosion: The entry of generic versions of NDC 69584-0091 leads to a rapid and significant decline in market share and price for the branded product.

Impact of Generic Entry

The expiration of market exclusivity for the API in NDC 69584-0091 triggers the entry of generic competitors, fundamentally altering the market dynamics.

Timeline of Generic Entry

Generic entry typically occurs upon the expiration of the primary patent or the expiration of associated regulatory exclusivities.

• Anticipated Entry Date: Industry analysts and market intelligence firms track patent expiry dates and potential legal challenges to forecast generic entry. For example, if the core patent expires in Q4 2024, generic competition could emerge in Q1 2025.
• First-to-File (FTF) Opportunities: The Hatch-Waxman Act provides a 180-day market exclusivity period for the first generic applicant to successfully challenge a patent or be the first to submit an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification [3].

Price Erosion Post-Generic Launch

The introduction of generic alternatives leads to substantial price erosion for the branded drug.

• Initial Price Drop: The first generic launch can result in an immediate price drop of 20-30% for the branded product.
• Subsequent Price Declines: As more generic manufacturers enter the market, prices continue to fall. Within 1-2 years of the first generic launch, the price of the branded drug can decrease by 60-80% or more.
• Average Selling Price (ASP) vs. Wholesale Acquisition Cost (WAC): It is important to distinguish between WAC, the manufacturer's list price, and ASP, the price after rebates and discounts. Generic competition primarily impacts ASP.

Price Projections for NDC 69584-0091

Price projections for NDC 69584-0091 depend on several factors, including the current stage of its product lifecycle, the presence of generic competition, and evolving healthcare policy.

Baseline Price (Pre-Generic)

The baseline price for a branded drug like NDC 69584-0091 is determined by its R&D costs, manufacturing expenses, market value, and the pricing strategies of the innovator company. This price is influenced by therapeutic value and the unmet needs it addresses.

• Average WAC: If NDC 69584-0091 is a specialty drug, its WAC could range from $5,000 to $20,000 per month or more. For a more common therapeutic, it might be several hundred dollars per month.

Post-Generic Price Trajectory

The price trajectory after generic entry is characterized by rapid decline.

Timeframe Post-Generic Launch	Projected Price Change (from pre-generic ASP)
0-6 Months	-30% to -50%
6-18 Months	-50% to -75%
18-36 Months	-70% to -85%

These percentages are estimates and can vary significantly based on the number of generic competitors, the specific therapeutic area, and payer negotiations.

Factors Influencing Future Pricing

Beyond generic entry, several other factors will influence the future pricing of NDC 69584-0091.

• Payer Negotiations and Value-Based Pricing: Payers are increasingly demanding evidence of value and may tie reimbursement to patient outcomes. This can lead to more complex pricing agreements.
• Market Access Strategies: The manufacturer's ability to secure favorable formulary placement and navigate prior authorization requirements will impact the net price realized.
• Competition from New Entrants: Development of new branded therapies or biosimil (for biologic drugs) could further pressure pricing.
• Government Policy Changes: Potential changes in drug pricing regulations, such as Medicare negotiation or international reference pricing, could impact the drug's price ceiling. For instance, the Inflation Reduction Act (IRA) allows Medicare to negotiate prices for certain high-cost drugs [4].
• Off-Label Use and New Indications: If NDC 69584-0091 is approved for new indications or experiences significant off-label use, this could expand its market and potentially influence pricing dynamics, though regulatory approval for new indications is typically required for official pricing adjustments.

Strategic Considerations for Stakeholders

Stakeholders involved with NDC 69584-0091, including the innovator company, potential generic manufacturers, and payers, must adapt their strategies to the evolving market.

Innovator Company Strategies

For the branded product, strategies focus on maximizing revenue during the exclusivity period and managing the transition to generic competition.

• Lifecycle Management: Exploring opportunities for new formulations, combination therapies, or new indications to extend market exclusivity.
• Authorized Generics: The innovator may choose to launch its own generic version to capture a share of the generic market.
• Market Access and Patient Support Programs: Continuing to invest in programs that facilitate patient access and adherence.

Generic Manufacturer Strategies

Generic companies aim to enter the market efficiently and capture market share post-exclusivity.

• FTF Opportunity: Securing 180-day exclusivity through a successful Paragraph IV challenge can provide a significant competitive advantage.
• Manufacturing Efficiency: Optimizing manufacturing processes to achieve competitive cost structures.
• Distribution Networks: Establishing robust distribution channels to reach pharmacies and wholesalers quickly.

Payer Strategies

Payers focus on managing costs while ensuring access to medically necessary treatments.

• Formulary Management: Actively managing formularies to favor cost-effective options, including generics.
• Negotiation Leverage: Using the threat of generic entry to negotiate significant rebates with branded manufacturers.
• Utilization Management: Implementing tools like prior authorization and step therapy to control prescribing of higher-cost options.

Key Takeaways

NDC 69584-0091, like other pharmaceuticals, operates within a dynamic market influenced by patent lifecycles, regulatory frameworks, and payer policies. The expiration of market exclusivity for its API will be the primary driver of significant price erosion, leading to its price falling by an estimated 70-85% within three years of generic launch. Payer negotiations, competition from other therapies, and evolving healthcare regulations will further shape its market trajectory. Stakeholders must adopt proactive strategies to navigate these changes, with innovator companies focusing on lifecycle management and generic manufacturers on efficient market entry.

Frequently Asked Questions

1. What is the most likely date for generic entry for NDC 69584-0091? Generic entry is contingent upon the expiration of all relevant patents and regulatory exclusivities. Without specific patent data for the API, a precise date cannot be determined. However, market intelligence platforms specializing in drug patent expiration can provide this information.

2. How will the Inflation Reduction Act impact the price of NDC 69584-0091 if it is a high-cost drug subject to negotiation? If NDC 69584-0091 meets the criteria for Medicare negotiation under the IRA (e.g., high spending, long period without generic competition), its price could be subject to government negotiation, potentially leading to a mandated price reduction. The specific impact depends on the drug's qualification and the negotiation outcomes.

3. Can the innovator company extend market exclusivity for NDC 69584-0091 beyond patent expiration? Yes, market exclusivity can be extended through various means, including new formulation patents, new use patents, or obtaining new regulatory exclusivities from the FDA for significant new indications.

4. What is the typical difference in Average Selling Price (ASP) between a branded drug and its generic equivalent shortly after generic launch? Shortly after the first generic launch, the ASP of the branded drug typically decreases by 30-50%, while the generic version establishes its price point.

5. How do payers determine formulary placement for drugs like NDC 69584-0091? Payers consider clinical efficacy, safety, cost-effectiveness, therapeutic alternatives, patient demand, and manufacturer rebates when determining formulary placement. Drugs demonstrating superior value or offering significant cost savings are more likely to receive preferred placement.

Citations

[1] U.S. Food & Drug Administration. (2022). Patent Term Extension (PTE). Retrieved from https://www.fda.gov/about-fda/office-grants-appropriations-budget/patent-term-extension-pte

[2] U.S. Food & Drug Administration. (2018). Orphan Drug Act. Retrieved from https://www.fda.gov/patients/drug-development-process/orphan-drug-act

[3] U.S. Food & Drug Administration. (2021). Generic Drugs: Abbreviated New Drug Application (ANDA). Retrieved from https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

[4] Congress.gov. (2022). H.R.5376 - Inflation Reduction Act of 2022. Retrieved from https://www.congress.gov/bill/117th-congress/house-bill/5376