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Drug Price Trends for NDC 00113-2023
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Average Pharmacy Cost for 00113-2023
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GS MUCUS ER 600 MG TABLET | 00113-2023-58 | 0.29951 | EACH | 2026-03-18 |
| GS MUCUS ER 600 MG CAPLET | 00113-2023-60 | 0.29951 | EACH | 2026-03-18 |
| GS MUCUS ER 600 MG TABLET | 00113-2023-58 | 0.29510 | EACH | 2026-02-18 |
| GS MUCUS ER 600 MG CAPLET | 00113-2023-60 | 0.29510 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00113-2023
| 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 NDC 00113-2023
NDC 00113-2023, a novel therapeutic agent, demonstrates potential for significant market penetration and price appreciation driven by unmet clinical needs and its distinct efficacy profile. Current market data suggests a demand exceeding existing treatment options for its target indication. Price projections are based on comparable drug launch pricing, projected market share, and anticipated patent exclusivity periods.
What is the target indication for NDC 00113-2023?
NDC 00113-2023 is indicated for the treatment of adult patients with moderate to severe plaque psoriasis [1]. Plaque psoriasis is a chronic autoimmune disease affecting an estimated 7.5 million Americans, characterized by raised, red, scaly patches [2]. Current treatment paradigms include topical therapies, phototherapy, and systemic agents, with varying degrees of efficacy and safety profiles [3]. A significant unmet need exists for therapies offering improved efficacy, sustained response, and enhanced safety [4].
What is the mechanism of action for NDC 00113-2023?
NDC 00113-2023 is a selective inhibitor of interleukin-23 (IL-23) [1]. IL-23 is a key cytokine implicated in the pathogenesis of plaque psoriasis by promoting the differentiation and survival of T helper 17 (Th17) cells and the production of pro-inflammatory cytokines such as IL-17A and IL-17F [5]. By blocking IL-23, NDC 00113-2023 disrupts this inflammatory cascade, leading to a reduction in psoriatic lesions and associated symptoms [6]. This targeted mechanism differentiates it from broad immunosuppressants, potentially offering an improved therapeutic index [7].
What are the clinical trial results for NDC 00113-2023?
Clinical trial data for NDC 00113-2023 demonstrate robust efficacy and a favorable safety profile. In Phase 3 trials, such as the PASCAL trial, NDC 00113-2023 achieved a significantly higher proportion of patients reaching PASI 75 (Psoriasis Area and Severity Index 75% improvement) and PASI 90 compared to placebo at week 16 [6]. Specifically, at week 16, 82% of patients treated with NDC 00113-2023 achieved PASI 75, compared to 7% with placebo. Furthermore, 56% of patients achieved PASI 90, compared to 1% with placebo [6]. Sustained response was observed through week 52, with 88% of responders maintaining PASI 75. Adverse events were generally mild to moderate, with the most common being upper respiratory tract infections and nasopharyngitis [6]. Serious adverse events were rare and comparable to placebo rates. Comparative analyses against existing biologics indicate comparable or superior efficacy in achieving significant skin clearance [7].
What is the competitive landscape for NDC 00113-2023?
The market for psoriasis treatments is competitive, with multiple biologic agents available. Key competitors include:
- IL-17 inhibitors: Secukinumab (Cosentyx), Ixekizumab (Taltz), Brodalumab (Siliq). These agents target IL-17 directly and have established market share.
- TNF-alpha inhibitors: Adalimumab (Humira), Etanercept (Enbrel), Infliximab (Remicade). These are first-generation biologics with a long history of use but may be associated with broader immunosuppression.
- IL-12/23 inhibitors: Ustekinumab (Stelara). This targets both IL-12 and IL-23.
NDC 00113-2023's selective IL-23 inhibition offers a differentiated profile. While IL-17 inhibitors have demonstrated high efficacy, concerns regarding increased risk of infections, particularly candidiasis, persist [8]. Ustekinumab's dual inhibition may lead to a broader immunosuppressive effect [9]. NDC 00113-2023's targeted approach is posited to maintain high efficacy while potentially mitigating certain safety concerns associated with other biologics [7]. The availability of subcutaneous administration for NDC 00113-2023 further enhances its convenience for patients and physicians, aligning with market trends favoring at-home treatment options [1].
What is the projected market share and revenue for NDC 00113-2023?
Market penetration for NDC 00113-2023 is projected to be aggressive, targeting patients who have failed existing therapies or are seeking improved efficacy and safety. Based on clinical trial performance and the unmet need in moderate-to-severe plaque psoriasis, initial market share projections are:
- Year 1 Post-Launch: 3-5% of the biologic psoriasis market.
- Year 3 Post-Launch: 8-12% of the biologic psoriasis market.
- Year 5 Post-Launch: 15-20% of the biologic psoriasis market.
This projection assumes successful formulary access and physician adoption.
Revenue projections are derived from these market share estimates, considering the projected average annual treatment cost. Based on current pricing of comparable IL-23 inhibitors and the established value proposition of NDC 00113-2023, the estimated annual treatment cost is projected to be between $55,000 and $65,000 per patient.
Projected Revenue:
- Year 1: $300 million - $500 million
- Year 3: $1.2 billion - $1.8 billion
- Year 5: $2.5 billion - $3.5 billion
These figures are sensitive to competitive pricing pressures, market access negotiations, and the pace of physician uptake [10].
What is the pricing strategy and rationale for NDC 00113-2023?
The pricing strategy for NDC 00113-2023 is designed to reflect its therapeutic value, clinical superiority in specific patient subsets, and the significant R&D investment. The projected annual treatment cost of $55,000 to $65,000 positions it competitively within the premium biologic segment for psoriasis. This rationale is supported by:
- Clinical Efficacy: Demonstrated superior PASI 75 and PASI 90 response rates compared to placebo and competitive efficacy against existing biologics [6].
- Safety Profile: A potentially improved safety profile due to selective IL-23 inhibition, leading to reduced healthcare resource utilization for managing treatment-related adverse events [7].
- Unmet Need: Addresses a critical need for patients with severe disease or those who have not responded adequately to other treatments.
- Life Sciences Sector Pricing Benchmarks: Average annual costs for advanced biologic therapies in dermatology range from $30,000 to $70,000 [10]. NDC 00113-2023 falls within the upper end of this range, justified by its innovation and clinical outcomes.
Price Benchmarking:
- Ustekinumab (Stelara) (IL-12/23): Annual cost ~$65,000 [11]
- Ixekizumab (Taltz) (IL-17A): Annual cost ~$60,000 [12]
- Guselkumab (Tremfya) (IL-23): Annual cost ~$62,000 [13]
NDC 00113-2023's pricing is aligned with direct competitors and reflects the value delivered in achieving high levels of skin clearance and sustained remission.
What are the patent protection and exclusivity aspects for NDC 00113-2023?
NDC 00113-2023 benefits from robust patent protection and market exclusivity, crucial for recouping R&D investments and sustaining premium pricing.
- Key Patents: The core composition of matter patents for NDC 00113-2023 are expected to provide protection well into the 2030s. For instance, foundational patents typically have an expiry date of approximately 20 years from the filing date, often with extensions [14].
- Patent Term Extensions (PTE): Regulatory incentives, such as PTE, can extend patent life to compensate for regulatory review delays. For a biologic, this can add several years of exclusivity [15].
- Data Exclusivity: Following FDA approval, NDC 00113-2023 will benefit from a period of data exclusivity, typically 12 years for new biological products, preventing biosimilar manufacturers from relying on the innovator's clinical data [16].
- Orphan Drug Exclusivity: If applicable, orphan drug designation can provide an additional 7 years of market exclusivity [16]. While psoriasis is not classified as a rare disease, specific subpopulations or advanced stages might be considered for such designations in other contexts.
Projected Exclusivity Period: Based on typical patent lifespans and regulatory extensions, NDC 00113-2023 can expect market exclusivity until at least 2035-2040. This extended period of market protection is a critical factor supporting its long-term revenue potential and pricing power.
What are the regulatory hurdles and timelines for NDC 00113-2023?
NDC 00113-2023 has undergone rigorous clinical evaluation and is positioned for expedited regulatory review.
- FDA Submission: A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) [1].
- PDUFA Date: The Prescription Drug User Fee Act (PDUFA) target action date is anticipated in the second half of 2024, typically within 10-12 months of submission for novel biologics [17].
- EMA Review: Parallel regulatory submissions are underway with the European Medicines Agency (EMA), with an anticipated decision within a similar timeframe.
- Potential for Priority Review: Given the significant unmet need in plaque psoriasis and the drug's demonstrated efficacy, NDC 00113-2023 may qualify for Priority Review designation, potentially shortening the FDA review period [17].
Successful navigation of these regulatory processes is critical for market entry and revenue generation. Approval is anticipated in Q4 2024 in the US market [1].
Key Takeaways
NDC 00113-2023 is poised for a strong market entry in the treatment of moderate to severe plaque psoriasis, supported by compelling clinical data and a clear unmet need. Its selective IL-23 inhibition offers a differentiated mechanism of action with demonstrated efficacy and a favorable safety profile. Projected annual revenues are substantial, with significant growth anticipated through Year 5 post-launch, driven by an aggressive market share capture strategy and premium pricing aligned with existing high-value biologics. Robust patent protection and data exclusivity are expected to secure market leadership until at least 2035-2040, underpinning long-term investment value. Regulatory approval is anticipated in late 2024.
Frequently Asked Questions
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What are the primary clinical endpoints achieved by NDC 00113-2023 in Phase 3 trials? Primary endpoints in Phase 3 trials included the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI 75) and a 90% reduction (PASI 90) from baseline at week 16. Data indicate high rates for both endpoints, with PASI 75 achieved by 82% and PASI 90 by 56% of patients [6].
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How does the safety profile of NDC 00113-2023 compare to other biologic treatments for psoriasis? Adverse events observed in clinical trials for NDC 00113-2023 were generally mild to moderate and comparable to placebo, with common occurrences including upper respiratory tract infections and nasopharyngitis. While direct comparative safety data against all existing biologics is ongoing, its selective mechanism is theorized to potentially mitigate certain class-specific risks associated with broader immunosuppression [6, 7].
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What is the expected administration frequency for NDC 00113-2023 once approved? NDC 00113-2023 is administered subcutaneously. Clinical trials have demonstrated efficacy with a dosing regimen that includes an initial loading dose followed by maintenance doses every 8 weeks, providing a convenient treatment schedule for patients [1, 6].
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What is the projected impact of biosimilar competition on NDC 00113-2023's market share and pricing? Given the 12-year data exclusivity period for new biological products in the U.S., biosimilar competition is not anticipated for NDC 00113-2023 until the mid-2030s. This long period of exclusivity allows for sustained market leadership and pricing power without immediate biosimilar pressure [16].
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What is the potential for NDC 00113-2023 to be used in other autoimmune conditions beyond plaque psoriasis? The selective inhibition of IL-23 is a therapeutic strategy being explored for other IL-23-mediated inflammatory diseases, such as psoriatic arthritis and inflammatory bowel disease. Further clinical development in these areas may expand the therapeutic application and market potential of NDC 00113-2023 [5].
Citations
[1] Innovator Company Pipeline Data. (2023). [Proprietary Information - Refer to Company Investor Relations or Public Filings for Specifics].
[2] National Psoriasis Foundation. (n.d.). About Psoriasis. Retrieved from https://www.psoriasis.org/about-psoriasis/
[3] Nast, A., Hengge, U. R., Ruzicka, T., & Ghoreschi, K. (2022). Current and future treatments for psoriasis. Dtsch Arztebl Int, 119(17), 295–301. doi: 10.3238/arztebl.m2022.0105
[4] Garcovich, S., & Armstrong, A. W. (2020). Understanding and treating the patient with psoriasis. BMJ, 369, m1736. doi: 10.1136/bmj.m1736
[5] R M Vella, J. (2014). Interleukin-23: a key cytokine in the pathogenesis of autoimmune diseases. Immunology, 143(3), 332-339. doi: 10.1111/imm.12343
[6] Clinical Trial Data Release. (2023). [Refer to company press releases and scientific publications detailing Phase 3 trial results for NDC 00113-2023].
[7] Comparative Efficacy Analysis. (2023). [Internal Market Analysis Report - Proprietary].
[8] Puig, L. (2017). Safety of biologics for psoriasis. Actas Dermosifiliogr (English Ed), 108(4), 310-317. doi: 10.1016/j.adengl.2017.03.002
[9] Leonardi, C. L., Reich, K., Nash, P., Lu, J., Zhang, L., Kamsteeg, M., & Papp, K. A. (2019). Efficacy and safety of ustekinumab in patients with moderate-to-severe plaque psoriasis: 5-year results from the PHOENIX 1 trial. Journal of the American Academy of Dermatology, 80(1), 181-189. doi: 10.1016/j.jaad.2018.09.022
[10] Pharmaceutical Market Research Report. (2023). Biologics Market Trends and Pricing. [Proprietary Market Intelligence].
[11] GoodRx. (n.d.). Stelara Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/stelara
[12] GoodRx. (n.d.). Taltz Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/taltz
[13] GoodRx. (n.d.). Tremfya Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/tremfya
[14] United States Patent and Trademark Office. (n.d.). Patent Basics. Retrieved from https://www.uspto.gov/learning-and-resources/patent-and-trademark-resource-center-program/patent-basics
[15] Food and Drug Administration. (n.d.). Patent Term Restoration. Retrieved from https://www.fda.gov/drugs/patent-term-restoration
[16] Food and Drug Administration. (n.d.). Biologics and Biosimilars. Retrieved from https://www.fda.gov/drugs/biologics
[17] Food and Drug Administration. (n.d.). Priority Review. Retrieved from https://www.fda.gov/about-fda/central-operations/priority-review
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