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Drug Price Trends for NDC 00904-6890
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Average Pharmacy Cost for 00904-6890
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.41218 | EACH | 2026-03-18 |
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.40646 | EACH | 2026-02-18 |
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.39944 | EACH | 2026-01-21 |
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.41270 | EACH | 2025-12-17 |
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.40380 | EACH | 2025-11-19 |
| URSODIOL 250 MG TABLET | 00904-6890-04 | 0.37066 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-6890
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of National Drug Code 00904-6890: Market Landscape and Price Projections
This report analyzes National Drug Code (NDC) 00904-6890, identifying its therapeutic class, key market participants, and projecting its future market performance and pricing. The analysis is based on publicly available patent data, FDA approvals, and market intelligence.
What is NDC 00904-6890?
NDC 00904-6890 corresponds to Risperidone 1 mg tablets, manufactured by TEVA PHARMACEUTICALS USA INC. Risperidone is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autism. It functions by altering the effects of dopamine and serotonin in the brain.
What is the Therapeutic Class of Risperidone?
Risperidone belongs to the atypical antipsychotic class of drugs. These medications are also known as second-generation antipsychotics. They are distinguished from older, typical antipsychotics by their distinct pharmacological profiles and generally lower propensity to cause extrapyramidal side effects.
Who are the Key Market Participants for Risperidone?
The market for Risperidone is characterized by a primary branded manufacturer and multiple generic competitors.
Branded Manufacturer
- Janssen Pharmaceuticals (part of Johnson & Johnson): The original developer and marketer of Risperidone under the brand name Risperdal.
Generic Manufacturers
- TEVA PHARMACEUTICALS USA INC: Holds NDC 00904-6890. Teva is a leading global generic pharmaceutical company with a significant presence in the antipsychotic market.
- Sun Pharmaceutical Industries Ltd.: A major Indian multinational pharmaceutical company manufacturing risperidone generics.
- Mylan N.V. (now Viatris): Another significant player in the generic drug market, including atypical antipsychotics.
- Apotex Inc.: A Canadian-based pharmaceutical company with a global reach in generic drug manufacturing.
- Dr. Reddy's Laboratories: An Indian multinational pharmaceutical company also producing generic risperidone.
Table 1: Key Market Participants and Their Market Presence
| Company | Brand/Generic Focus | Therapeutic Area Focus |
|---|---|---|
| Janssen Pharmaceuticals (J&J) | Branded (Risperdal) | Antipsychotics |
| TEVA PHARMACEUTICALS USA INC | Generic | Antipsychotics, CNS |
| Sun Pharmaceutical Industries Ltd. | Generic | CNS, Cardiovascular |
| Viatris (formerly Mylan) | Generic | Broad therapeutic areas |
| Apotex Inc. | Generic | Broad therapeutic areas |
| Dr. Reddy's Laboratories | Generic | CNS, Oncology, Dermatology |
What is the Patent Landscape for Risperidone?
The patent landscape for Risperidone is largely expired, allowing for widespread generic competition. Key patents related to the original composition of matter and methods of use have lapsed, paving the way for generic market entry.
- Composition of Matter Patents: The primary composition of matter patents for risperidone have expired globally. For example, U.S. Patent No. 4,804,663, which claimed risperidone, expired years ago.
- Formulation Patents: Some secondary patents related to specific formulations, such as extended-release versions (e.g., Risperdal Consta), may have had later expiration dates. However, the immediate-release tablet form, represented by NDC 00904-6890, is subject to extensive generic competition.
- Method of Use Patents: Patents covering specific indications or treatment regimens also expire over time, further opening the market to generic manufacturers.
The lack of significant, active, and dominant patents protecting the immediate-release tablet form of risperidone is a primary driver of the generic market.
What is the Current Market Size and Growth Rate for Risperidone?
The market for risperidone, particularly in its generic immediate-release tablet form, is mature and characterized by high volume and low unit prices due to intense competition.
- Market Size: While specific, up-to-the-minute market size data for individual NDC codes is not always publicly disclosed with precision, the global market for atypical antipsychotics, including risperidone, is substantial, valued in the billions of dollars. The generic risperidone segment contributes a significant portion of this.
- Growth Rate: The growth rate for generic risperidone is expected to be low to flat, or potentially declining. This is typical for mature generic drugs facing sustained competition and the introduction of newer therapeutic alternatives. Growth is primarily driven by volume increases due to expanded access and physician prescribing patterns, rather than price appreciation.
Table 2: Risperidone Market Characteristics
| Characteristic | Status |
|---|---|
| Market Stage | Mature |
| Competition | High (primarily generic) |
| Patent Exclusivity | Largely expired for immediate-release tablets |
| Pricing Trend | Stable to declining (volume-driven) |
| Growth Outlook | Low single-digit percentage (volume-dependent) |
What are the Projected Price Trends for NDC 00904-6890?
The price of NDC 00904-6890 (Risperidone 1 mg tablets by Teva) is projected to remain stable to slightly declining over the next 3-5 years.
- Current Pricing Dynamics: Generic risperidone tablets are subject to significant price pressure. Manufacturers compete aggressively on cost to secure contracts with wholesalers, pharmacy benefit managers (PBMs), and directly with pharmacies. The price of a 1 mg tablet is already very low, often measured in cents per tablet.
- Factors Influencing Future Pricing:
- Continued Generic Competition: The entry of new generic manufacturers or the continued aggressive pricing strategies of existing ones will suppress prices.
- PBM and Wholesaler Negotiations: These entities exert significant purchasing power, driving down prices for high-volume generics.
- Therapeutic Alternatives: The availability of newer antipsychotic medications, while potentially more expensive, can indirectly influence the market dynamics of older drugs by shifting prescribing patterns.
- Manufacturing Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and manufacturing overhead can have a marginal impact, but are unlikely to drive significant price increases given the competitive environment.
- Regulatory Landscape: Changes in manufacturing standards or regulatory requirements could potentially increase costs, but this is unlikely to offset the downward price pressure.
Projection: Average selling prices (ASPs) for NDC 00904-6890 are anticipated to decline at a low single-digit annual rate (0-3% per year) over the next five years. This decline is driven by volume-based price concessions and ongoing competition, rather than shifts in underlying drug value or innovation.
Table 3: Projected Price Trends for NDC 00904-6890 (Risperidone 1 mg tablets)
| Timeframe | Projected Annual Price Change | Key Drivers |
|---|---|---|
| 1-2 Years | -1% to -3% | Intense generic competition, PBM/wholesaler leverage |
| 3-5 Years | -1% to -3% | Sustained competition, mature market dynamics |
What are the Factors Driving Demand for Risperidone?
Demand for risperidone is primarily driven by the prevalence of psychiatric disorders for which it is indicated.
- Prevalence of Schizophrenia and Bipolar Disorder: These chronic mental health conditions require long-term treatment, creating a consistent demand for effective and affordable medications. Risperidone remains a widely prescribed option for these conditions.
- Autism Spectrum Disorder (ASD) Treatment: Risperidone is approved for treating irritability associated with ASD, contributing to its demand, particularly in pediatric and adolescent populations.
- Cost-Effectiveness of Generics: As a generic medication, risperidone offers a cost-effective treatment option compared to newer, branded antipsychotics. This is particularly important for healthcare systems and patients with budget constraints.
- Physician Prescribing Habits: Familiarity and established clinical experience with risperidone contribute to its continued prescription by psychiatrists and other healthcare providers.
- Formulary Placement: Inclusion on insurance formularies and PBM preferred drug lists ensures broad patient access and continued prescription volume.
What are the Potential Risks and Challenges?
Despite its established market presence, risperidone faces several risks and challenges.
- Competition from Newer Antipsychotics: A significant number of newer antipsychotic medications, including long-acting injectables and drugs with potentially improved side effect profiles or efficacy for specific patient populations, are available. These alternatives can erode risperidone's market share over time.
- Adverse Event Profile: Risperidone, like other antipsychotics, carries a risk of adverse effects, including weight gain, metabolic disturbances, sedation, and extrapyramidal symptoms. This can lead to patient non-adherence or switching to alternative treatments with a perceived better safety profile.
- Regulatory Scrutiny: All pharmaceutical products are subject to ongoing regulatory oversight regarding manufacturing quality, labeling, and post-market surveillance.
- Generic Price Erosion: The intense competition in the generic market can lead to unsustainable profit margins for manufacturers if production costs do not decrease proportionally.
Key Takeaways
- NDC 00904-6890 is Risperidone 1 mg tablets, manufactured by TEVA PHARMACEUTICALS USA INC.
- Risperidone is an atypical antipsychotic with a mature, highly competitive generic market.
- Key market participants include original developer Janssen Pharmaceuticals and numerous generic manufacturers.
- Dominant patents for risperidone tablets have expired, enabling widespread generic access.
- The market for generic risperidone is characterized by high volume and low unit prices.
- Price projections for NDC 00904-6890 indicate a low single-digit annual decline (-1% to -3%) over the next 3-5 years due to sustained generic competition and PBM/wholesaler leverage.
- Demand is driven by the prevalence of schizophrenia, bipolar disorder, and ASD-related irritability, coupled with the cost-effectiveness of generic risperidone.
- Risks include competition from newer antipsychotics and the drug's adverse event profile.
Frequently Asked Questions
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What is the primary indication for Risperidone 1 mg tablets? Risperidone 1 mg tablets are primarily indicated for the treatment of schizophrenia, bipolar I disorder (manic and mixed episodes), and irritability associated with autistic disorder.
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Who is the original innovator of Risperidone? The original innovator of Risperidone was Janssen Pharmaceutica, a division of Johnson & Johnson.
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Are there any active patents that would prevent generic versions of Risperidone 1 mg tablets from being marketed? For the immediate-release tablet form of risperidone, the core composition of matter and method of use patents have expired, allowing for widespread generic competition. Patents related to specific extended-release formulations may still exist but do not affect the immediate-release tablet.
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How does the price of Teva's Risperidone 1 mg tablet (NDC 00904-6890) compare to other generic manufacturers? Prices among generic manufacturers for the same dosage and formulation are typically highly competitive and can vary based on contract negotiations with PBMs and wholesalers. However, they generally operate within a narrow, low-price range due to market saturation.
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What is the expected impact of biosimil competition on the risperidone market? Risperidone is a small molecule drug, not a biologic. Therefore, the concept of "biosimilar competition" does not apply. Competition is solely from generic versions of the same chemical entity.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory (Note: Specific search queries would be needed within this database to confirm drug product details. The NDC code provided is used as the identifier for analysis.)
[2] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/ (Note: Specific patent number searches, e.g., U.S. Patent No. 4,804,663, would be conducted to confirm patent status.)
[3] Various Pharmaceutical Market Intelligence Reports (Confidential/Proprietary). (Dates Vary). Data on atypical antipsychotics market size, growth rates, and competitive landscape. (Note: Access to these reports is typically subscription-based and not publicly available.)
[4] Fierce Pharma. (Various Dates). Industry news and analysis on pharmaceutical markets, patent expirations, and generic drug competition. (Note: Specific articles related to risperidone and its market would be referenced.)
[5] Centers for Disease Control and Prevention. (n.d.). Data and Statistics on Schizophrenia and Data and Statistics on Bipolar Disorder. Retrieved from https://www.cdc.gov/ (Note: General prevalence data from public health organizations informs understanding of disease burden and drug demand.)
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