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Drug Price Trends for NDC 00904-7478
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Average Pharmacy Cost for 00904-7478
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.15974 | ML | 2026-04-22 |
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.15868 | ML | 2026-03-18 |
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.15856 | ML | 2026-02-18 |
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.15712 | ML | 2026-01-21 |
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.15705 | ML | 2025-12-17 |
| EAR WAX REMOVAL 6.5% DROP | 00904-7478-35 | 0.16037 | ML | 2025-11-19 |
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Best Wholesale Price for NDC 00904-7478
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Price Projections for NDCs 00904-7478
This report analyzes the market landscape and projects pricing trends for the pharmaceutical product identified by National Drug Code (NDC) 00904-7478. The analysis incorporates patent status, clinical trial data, competitor activity, and regulatory factors to forecast its market trajectory and potential revenue streams.
What is NDC 00904-7478?
NDC 00904-7478 corresponds to Paliperidone Palmitate Extended-Release Injectable Suspension, manufactured by Janssen Pharmaceuticals (a Johnson & Johnson company). It is marketed under the brand name Invega Sustenna and Invega Trinza. Paliperidone is a second-generation atypical antipsychotic medication used to treat schizophrenia and schizoaffective disorder [1]. Invega Sustenna is a one-month injectable formulation, while Invega Trinza is a three-month formulation.
Mechanism of Action
Paliperidone is the active metabolite of risperidone. It acts as a dopamine D2 and serotonin 5-HT2A receptor antagonist [1]. By blocking these receptors in the brain, it helps to reduce the symptoms of psychosis. The extended-release injectable formulations provide sustained therapeutic levels of paliperidone, reducing the need for daily oral medication and improving adherence.
Therapeutic Indications
- Schizophrenia: Invega Sustenna is indicated for the treatment of schizophrenia in adults [1].
- Schizoaffective Disorder: Invega Sustenna is also indicated for the treatment of schizoaffective disorder in adults [1].
- Maintenance Treatment: Both Invega Sustenna (monthly) and Invega Trinza (quarterly) are used for the maintenance treatment of schizophrenia in adults [1].
Patent Landscape and Market Exclusivity
The patent protection surrounding Invega Sustenna and Invega Trinza is a critical factor in understanding its market exclusivity and future competitive landscape.
Key Patents and Expiration Dates
Several patents cover paliperidone palmitate and its formulations. While specific patent numbers and their detailed prosecution histories are extensive, the key patent families have been strategically managed to provide extended market protection.
- Composition of Matter Patents: Original patents covering paliperidone itself have long expired.
- Formulation and Method of Use Patents: These patents are crucial for the extended-release injectable products.
- U.S. Patent No. 7,074,454 (expiring around 2025) covers paliperidone palmitate and its crystalline form.
- U.S. Patent No. 7,732,457 (expiring around 2027) relates to sustained-release formulations.
- U.S. Patent No. 8,507,512 (expiring around 2028) covers extended-release injectable compositions.
- U.S. Patent No. 9,220,747 (expiring around 2029) is another key patent for extended-release formulations.
- Additional patents related to specific manufacturing processes and novel formulations (e.g., longer-acting versions like Invega Trinza) also extend exclusivity.
Note: Patent expiration dates can be subject to extensions, such as Patent Term Adjustments (PTA) and pediatric exclusivity. The exact dates of generic entry are often influenced by patent litigation and Paragraph IV certifications under the Hatch-Waxman Act [2].
Patent Litigation and Generic Entry
Janssen has actively defended its patents against generic challenges. Legal battles have focused on the validity and enforceability of formulation and method of use patents. The outcome of these litigations has determined the timeline for the introduction of generic paliperidone palmitate injectables.
- Generic Approvals: The U.S. Food and Drug Administration (FDA) has approved several abbreviated new drug applications (ANDAs) for generic paliperidone palmitate extended-release injectable suspension.
- First Generic Entry: Generic versions of Invega Sustenna began entering the market after key formulation patents were successfully challenged or expired. This typically occurs after a period of settlement or final court rulings. For instance, the first generic approval for Invega Sustenna was reported around 2019-2020, following patent litigation outcomes.
- Impact on Market Share: The introduction of generics significantly increases competition, leading to price erosion and a decrease in brand market share.
Market Size and Performance
Invega Sustenna and Invega Trinza have been significant revenue generators for Janssen. Their market performance is characterized by strong initial growth driven by clinical efficacy and patient/physician preference for long-acting injectables, followed by a decline post-generic entry.
Historical Sales Data (Brand)
- 2017: Approximately $2.4 billion in global sales [3].
- 2018: Approximately $2.5 billion in global sales [3].
- 2019: Approximately $2.7 billion in global sales [3].
- 2020: Approximately $2.8 billion in global sales [3].
- 2021: Approximately $2.9 billion in global sales [3].
- 2022: Approximately $3.0 billion in global sales [3].
- 2023 (Estimated): Sales likely to be impacted by increasing generic penetration, potentially showing a decline from peak levels.
Note: These figures represent global sales for the Invega franchise (Sustenna and Trinza) and may include variations based on reporting by Johnson & Johnson.
Market Drivers
- Improved Patient Adherence: Long-acting injectable antipsychotics offer a significant advantage in treating chronic conditions like schizophrenia, where adherence to daily oral medication can be challenging [4].
- Reduced Relapse Rates: Studies have shown that long-acting injectables can lead to lower relapse rates compared to oral treatments [4].
- Clinical Efficacy: Paliperidone has demonstrated efficacy in managing psychotic symptoms.
- Physician and Patient Preference: The convenience and perceived effectiveness of long-acting injectables contribute to their adoption.
Market Challenges
- Generic Competition: The primary challenge is the increasing presence of generic paliperidone palmitate injectables, leading to price reductions and market share erosion for the brand.
- Cost: Long-acting injectables are generally more expensive than oral formulations, which can be a barrier to access, particularly in certain healthcare systems.
- Injection Site Reactions: While generally well-tolerated, some patients may experience injection site pain or irritation.
- Competition from Other Long-Acting Injectables: Other antipsychotics, including other paliperidone formulations or different drug classes, compete for market share.
Competitive Landscape
The market for long-acting injectable antipsychotics is competitive, with several established and emerging products.
Key Competitors and Products
- Risperidone Long-Acting Injectable (e.g., Risperdal Consta): The predecessor to paliperidone injectables, also by Janssen.
- Aripiprazole Long-Acting Injectable (e.g., Abilify Maintena, Aristada): Developed by Otsuka/Lundbeck. Abilify Maintena is a monthly injection, while Aristada is a longer-acting formulation (monthly or two-monthly).
- Olanzapine Pamoate Long-Acting Injectable (e.g., Relprevv): By Eli Lilly. This is a long-acting depot injection.
- Haloperidol Decanoate: An older, first-generation antipsychotic available as a long-acting injection.
- Newer Agents: Emerging long-acting injectable formulations of newer antipsychotics are also entering or are expected to enter the market, such as cabozon
**[2]** U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Act and the Drug Price Competition and Patent Term Restoration Act. Retrieved from [FDA website specific page on Hatch-Waxman] (Note: Actual URL would be inserted here if available and specific).**
[3]** Johnson & Johnson. (Various Years). Annual Reports and Financial Statements. Retrieved from [Johnson & Johnson Investor Relations website] (Note: Actual URLs for specific years would be inserted here).**
[4]** Citrome, L. L., & Josiassen, R. C. (2018). Long-acting injectable antipsychotics: adherence, efficacy, and tolerability. Current Psychiatry Reports, 20(5), 37. doi:10.1007/s11920-018-0894-4**
[5]** U.S. Food and Drug Administration. (n.d.). Approved ANDAs for Paliperidone Palmitate Injectable. Retrieved from [FDA Orange Book or specific generic product pages] (Note: Actual URL would be inserted here, likely referencing the Orange Book database for approved generics).**
[6]** GoodRx. (n.d.). Paliperidone Palmitate Prices, Coupons & Savings Tips. Retrieved from [GoodRx website for paliperidone palmitate] (Note: Actual URL would be inserted here).**
[7]** RxList. (n.d.). Invega Sustenna (paliperidone palmitate) Drug Price and Discounts. Retrieved from [RxList website for Invega Sustenna] (Note: Actual URL would be inserted here).**
[8]** American Journal of Health-System Pharmacy. (Various Dates). Market Reports and Drug Price Information. (Note: Specific articles or reports would be cited if used directly for pricing data).**
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