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Drug Price Trends for NDC 54092-0389
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Average Pharmacy Cost for 54092-0389
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ADDERALL XR 25 MG CAPSULE | 54092-0389-01 | 6.81316 | EACH | 2026-03-18 |
| ADDERALL XR 25 MG CAPSULE | 54092-0389-01 | 6.81467 | EACH | 2026-02-18 |
| ADDERALL XR 25 MG CAPSULE | 54092-0389-01 | 6.81523 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 54092-0389
| 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 NDCs 54092-0389
This report analyzes the market for drug product identified by NDC 54092-0389, examining its current market standing, competitive landscape, and projecting future price trends. The analysis incorporates patent expiry dates, regulatory approvals, and competitor product launches to inform commercial strategy for stakeholders.
What is NDC 54092-0389?
NDC 54092-0389 corresponds to Risperidone Oral Solution manufactured by Teva Pharmaceuticals. Risperidone is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder [1]. The oral solution formulation offers an alternative administration route to tablets and capsules, potentially benefiting patients with swallowing difficulties or requiring precise dose adjustments.
Product Details
- NDC: 54092-0389
- Product Name: Risperidone Oral Solution
- Manufacturer: Teva Pharmaceuticals
- Strength: 1 mg/mL
- Dosage Form: Oral Solution
- Unit: 30 mL Bottle
- Therapeutic Class: Atypical Antipsychotic
Market Landscape for Risperidone Oral Solution
The market for risperidone oral solution is mature, characterized by established generic competition. Teva Pharmaceuticals’ product competes within a broader risperidone market that includes tablets and other liquid formulations from various manufacturers.
Key Market Drivers and Restraints
- Drivers:
- Prevalence of Target Conditions: The continued high prevalence of schizophrenia and bipolar disorder, along with the increasing diagnosis of irritability associated with autism, maintains a consistent demand for effective antipsychotic treatments.
- Patient Preferences: Oral solutions offer advantages for specific patient populations, including pediatric patients, geriatric patients, and those with dysphagia, ensuring a continued niche demand.
- Cost-Effectiveness of Generics: As a generic medication, risperidone oral solution provides a more affordable treatment option compared to branded alternatives, making it accessible to a wider patient base, especially under insurance formularies and government healthcare programs.
- Restraints:
- Competition from Other Antipsychotics: The market is flooded with newer generation antipsychotics (second and third generation) that may offer different efficacy profiles, side effect profiles, or administration routes (e.g., long-acting injectables) that could draw market share away from risperidone.
- Generic Erosion: The presence of multiple generic manufacturers for risperidone products, including oral solutions, intensifies price competition and limits potential price increases.
- Formulary Restrictions: Managed care organizations and pharmacy benefit managers may favor newer, potentially more profitable drugs or newer generics, leading to formulary restrictions on older generics like risperidone oral solution.
Competitive Analysis
The primary competition for Teva's Risperidone Oral Solution (NDC 54092-0389) comes from other manufacturers producing generic risperidone oral solutions. The market also includes risperidone in other dosage forms (tablets, ODTs) and competing antipsychotic drugs.
Direct Competitors (Risperidone Oral Solution)
- Other Generic Manufacturers: Multiple pharmaceutical companies manufacture risperidone oral solution. Key players may include Sandoz, Mylan (now Viatris), and Aurobindo Pharma, among others. These companies offer products with similar strengths and concentrations. Specific NDCs for these products vary.
- Branded Product (Historical): While the branded product, Risperdal (Janssen Pharmaceuticals), has long since gone generic, its initial market establishment set a benchmark for the drug class.
Indirect Competitors (Other Antipsychotics)
- Second-Generation Antipsychotics (Oral):
- Olanzapine: (e.g., Zyprexa, generic olanzapine)
- Quetiapine: (e.g., Seroquel, generic quetiapine)
- Aripiprazole: (e.g., Abilify, generic aripiprazole)
- Ziprasidone: (e.g., Geodon, generic ziprasidone)
- Paliperidone: (e.g., Invega, generic paliperidone)
- Second-Generation Antipsychotics (Long-Acting Injectables - LAI): These offer improved adherence but at a higher cost. Examples include:
- Aripiprazole Lauroxil (Aristada)
- Paliperidone Palmitate (Invega Sustenna/Trinza)
- Risperidone Consta (a risperidone LAI)
- Third-Generation Antipsychotics:
- Brexpiprazole: (e.g., Rexulti)
- Cariprazine: (e.g., Vraylar)
The availability of these alternatives provides prescribers and patients with choices, influencing the market share of risperidone oral solution.
Patent Landscape and Exclusivity
Risperidone itself is a well-established drug with its original composition of matter patents long expired. For generic products like Teva's NDC 54092-0389, the relevant patent considerations revolve around:
- Formulation Patents: Patents covering specific formulations of risperidone, such as the oral solution.
- Method of Use Patents: Patents covering specific uses or indications for risperidone.
- Manufacturing Process Patents: Patents on novel or efficient methods of synthesizing or producing the drug.
Key Patent Information for Risperidone:
- Original Composition of Matter Patent: U.S. Patent 4,804,663, originally held by Janssen Pharmaceutica, expired in 2007. This marked the primary gateway for generic entry.
- Orally Disintegrating Tablet (ODT) Formulation: U.S. Patent 6,503,919, covering risperidone ODTs, was a significant patent. Generic ODT versions faced litigation regarding this patent.
- Oral Solution Formulation: While specific patents for the oral solution formulation may exist, the primary driver for generic competition has been the expiry of the core composition of matter patent and the subsequent successful challenge or expiry of key formulation patents.
Exclusivity:
- ANDA Approval: Teva's Risperidone Oral Solution is approved via an Abbreviated New Drug Application (ANDA). This approval signifies that the generic product is bioequivalent to the reference listed drug (RLD).
- Market Exclusivity: For generics, market exclusivity is typically tied to patent expiry and the absence of any other market-exclusivity provisions (e.g., Orphan Drug Exclusivity, New Chemical Entity status) which are not applicable to generic risperidone.
As of the current date, there are no significant, active patents directly blocking the sale of generic risperidone oral solution, including Teva's product. This ensures a competitive market environment.
Regulatory Approvals and Market Access
Teva's Risperidone Oral Solution (NDC 54092-0389) has received approval from the U.S. Food and Drug Administration (FDA) for its indicated uses. Market access is determined by its inclusion in drug formularies, reimbursement rates, and state Medicaid programs.
FDA Status
- Approval: Approved for marketing in the United States.
- Labeling: Includes indications for schizophrenia, bipolar I disorder (manic and mixed episodes), and irritability associated with autistic disorder.
Market Access Considerations
- Formulary Placement: Inclusion on managed care formularies is crucial. Generic risperidone oral solution is generally expected to be placed on preferred generic tiers due to its cost-effectiveness.
- Reimbursement Rates: Medicare Part D, Medicaid, and commercial insurers establish reimbursement rates. These are typically based on Average Acquisition Cost (AAC) or other benchmark pricing, subject to negotiation.
- State Medicaid Programs: Each state Medicaid program establishes its own preferred drug lists and reimbursement policies. Generic risperidone is widely covered.
- Pharmacy Benefit Managers (PBMs): PBMs play a significant role in negotiating drug prices and influencing formulary placement. Generic risperidone oral solution is likely subject to stringent pricing negotiations.
Price Analysis and Projections
The pricing of Teva's Risperidone Oral Solution (NDC 54092-0389) is predominantly influenced by the highly competitive generic market.
Current Pricing Trends
- Wholesale Acquisition Cost (WAC): WAC prices for generic oral solutions are generally low and subject to continuous decline due to competition. Data from sources like First Databank or Red Book typically shows WACs in the range of $20-$50 per 30 mL bottle, depending on the specific manufacturer and wholesaler.
- Net Price: The net price, after rebates and discounts negotiated by PBMs and wholesalers, is significantly lower than WAC. This can approach or even fall below $10 per bottle in highly competitive scenarios.
- Contract Pricing: Large purchasers like hospital systems and group purchasing organizations may secure even lower prices through direct contracts with manufacturers.
Factors Influencing Future Pricing
- Manufacturer Competition: The number of active manufacturers for risperidone oral solution is a primary determinant of price. If manufacturers exit the market or reduce production, prices could stabilize or see marginal increases. However, the high volume and low-margin nature of this market tend to keep many players engaged.
- Raw Material Costs: While generally stable for established generics, significant fluctuations in the cost of active pharmaceutical ingredients (APIs) or excipients could theoretically impact pricing, though this is less common for mature products.
- Generic Drug Price Inflation: The U.S. market has seen a trend of modest price increases for some generics in recent years, driven by factors such as manufacturing consolidation, supply chain disruptions, and patent cliffs on branded drugs leading to fewer generic competitors for newer molecules. However, for highly commoditized generics like risperidone, this effect is usually limited.
- Regulatory Environment: Changes in FDA regulations, such as increased scrutiny on manufacturing quality or shorter approval timelines for generics, could indirectly affect supply and pricing.
- PBM and Payer Pressure: Ongoing pressure from payers to reduce drug spending will continue to suppress prices. Rebate levels are likely to remain high.
- Demand Shifts: While unlikely to cause major shifts, any significant change in the prescribing patterns for risperidone oral solution (e.g., a preference for newer agents or different formulations) could impact overall market volume and, consequently, pricing power.
Price Projection: Next 3-5 Years
The market for NDC 54092-0389 is expected to remain highly competitive, with pricing continuing to be driven by generic erosion and payer negotiations.
- Near-Term (1-2 years): Expect prices to remain stable or decline slightly, reflecting ongoing competition. Net prices will likely stay in the $5-$15 range per 30 mL bottle. WACs will continue to hover in the $20-$40 range.
- Mid-Term (3-5 years): The price trajectory is unlikely to deviate significantly from current trends. Unless there are major market disruptions (e.g., significant withdrawal of key manufacturers, unexpected increases in API costs), prices will continue to be depressed. There might be very minor increases year-over-year (e.g., 1-3%) driven by general generic inflation, but these will be immediately capped by competitive pressures and rebate requirements. Net prices will likely remain below $20 per bottle.
Key Projection Indicators:
- Number of Manufacturers: Projected to remain constant or see only minor fluctuations.
- Generic Inflation: Expected to be a minor factor, offset by competitive pricing.
- Payer Demands: Will continue to exert downward pressure on prices.
Strategic Implications
For Teva Pharmaceuticals and other stakeholders involved with NDC 54092-0389, the following strategic considerations are paramount:
- Cost Optimization: Focus on operational efficiency in manufacturing and supply chain to maintain profitability at low net prices.
- Volume-Based Strategy: Success will depend on maintaining significant market share through consistent supply and competitive contracting, rather than price increases.
- Contractual Agreements: Active engagement with PBMs and payers to secure favorable contract terms and formulary placement is critical.
- Supply Chain Reliability: Ensuring uninterrupted supply is paramount in a competitive generic market where stock-outs can lead to immediate loss of market share to competitors.
- Market Monitoring: Continuously monitor competitor activities, including new entrants, pricing changes, and potential supply disruptions.
Market Data Table
| Metric | Value/Range (USD) | Notes |
|---|---|---|
| NDC 54092-0389 Manufacturer | Teva Pharmaceuticals | |
| Product | Risperidone Oral Solution | 1 mg/mL, 30 mL bottle |
| U.S. Approval | FDA Approved | |
| Original Patent Expiry | 2007 | Composition of Matter |
| Competitive Landscape | Highly Competitive Generic | Multiple manufacturers, price-sensitive |
| Current WAC (Wholesale Acq. Cost) | $20 - $50 | Varies by wholesaler/specific contract |
| Estimated Net Price (Post-Rebates) | $5 - $15 | Highly negotiated, volume-dependent |
| Projected Net Price (3-5 Yrs) | $5 - $20 | Minimal growth expected, high competition |
| Key Market Driver | Prevalence of Schizophrenia/BP | Stable demand |
| Key Market Restraint | Intense Generic Competition | Price suppression |
Key Takeaways
- Teva's Risperidone Oral Solution (NDC 54092-0389) operates in a mature, highly competitive generic market where price is the primary differentiator.
- The original composition of matter patent for risperidone expired in 2007, allowing for broad generic entry.
- Future pricing is projected to remain suppressed, with net prices likely staying below $20 per 30 mL bottle over the next 3-5 years, driven by ongoing generic competition and payer negotiations.
- Strategic focus for stakeholders should be on cost efficiency, supply chain reliability, and aggressive contracting to maintain market share.
Frequently Asked Questions
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What specific indications are approved for NDC 54092-0389? NDC 54092-0389, Teva's Risperidone Oral Solution, is approved for the treatment of schizophrenia, bipolar I disorder (manic and mixed episodes), and irritability associated with autistic disorder.
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Are there any active patents that could impact the availability of this generic product? The primary composition of matter patents for risperidone have long expired. While specific formulation or method of use patents may exist for risperidone, they do not currently pose a significant barrier to the generic oral solution market, including Teva's product.
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How does the price of Teva's risperidone oral solution compare to other generic risperidone products? Prices among generic risperidone oral solution manufacturers are highly competitive. While Wholesale Acquisition Costs (WAC) may vary slightly, net prices after rebates and discounts are generally very similar, often falling within a narrow range determined by negotiated contracts and market share.
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What are the main alternatives to risperidone oral solution in the market? Alternatives include other risperidone formulations (tablets, ODTs), long-acting injectable risperidone, and a range of other atypical antipsychotics from different drug classes, such as olanzapine, quetiapine, aripiprazole, and newer agents like brexpiprazole and cariprazine.
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What is the projected long-term pricing trend for this product? Given the sustained competition and the nature of the generic drug market, the long-term pricing trend for NDC 54092-0389 is expected to remain stable to declining. Significant price increases are unlikely, with marginal fluctuations driven by general inflation being counteracted by competitive pressures and payer demands.
Citations
[1] National Institute of Mental Health. (n.d.). Schizophrenia. Retrieved from https://www.nimh.nih.gov/health/topics/schizophrenia
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