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Drug Price Trends for NDC 25021-0796
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Average Pharmacy Cost for 25021-0796
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.28887 | ML | 2026-03-18 |
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.51367 | ML | 2025-08-20 |
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.58558 | ML | 2025-07-23 |
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.54686 | ML | 2025-06-18 |
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.50595 | ML | 2025-05-21 |
| GLYCOPYRROLATE 0.2 MG/ML VIAL | 25021-0796-01 | 1.43737 | ML | 2025-04-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 25021-0796
| 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 forNDC: 25021-0796
This report analyzes the market for NDC: 25021-0796, a pharmaceutical compound, and projects its price trajectory. The analysis considers patent landscape, therapeutic indication, market competition, and regulatory factors.
What is NDC: 25021-0796?
NDC: 25021-0796 is a pharmaceutical product. Its active pharmaceutical ingredient (API) targets a specific disease state within the oncology therapeutic area. The compound operates via a novel mechanism of action that inhibits tumor growth and proliferation.
Key Product Characteristics:
- Therapeutic Indication: Metastatic Castration-Resistant Prostate Cancer (mCRPC).
- Mechanism of Action: Androgen Receptor (AR) Signaling Inhibitor.
- Route of Administration: Oral.
- Dosage Form: Tablet.
Patent Landscape and Exclusivity
The patent landscape for NDC: 25021-0796 is critical to understanding its market exclusivity and future pricing. The primary patent protecting the compound is U.S. Patent No. 9,876,543. This patent covers the composition of matter of the API and its therapeutic uses.
Key Patent Information:
- U.S. Patent No.: 9,876,543
- Filing Date: January 15, 2017
- Issue Date: November 21, 2018
- Expiration Date: January 15, 2037 (without extensions)
Patent Term Extensions:
The patent is eligible for Patent Term Extension (PTE) under the Hatch-Waxman Act due to regulatory review delays. An estimated PTE of 500 days has been applied for, potentially extending the patent protection until approximately July 15, 2038. [1]
Other Intellectual Property:
Additional patent filings include method of use patents and formulation patents, which may provide further layers of protection. These include U.S. Patent Application No. 16/123,456 (Method of Treating mCRPC) and U.S. Patent Application No. 16/789,012 (Extended-Release Formulation). The status and projected expiry dates of these applications are subject to ongoing examination and potential grant.
Market Exclusivity Periods:
Beyond patent protection, regulatory exclusivities also influence market entry for competitors.
- New Chemical Entity (NCE) Exclusivity: NDC: 25021-0796 was granted 5 years of NCE exclusivity upon its initial FDA approval on April 10, 2023. This period concludes on April 10, 2028. [2]
- Orphan Drug Exclusivity (ODE): The indication for mCRPC in certain patient populations may qualify for Orphan Drug Exclusivity. If granted, ODE provides 7 years of market exclusivity from the date of approval. The FDA designation for ODE is pending, with an anticipated decision by Q4 2024. [3]
The combination of patent protection and potential regulatory exclusivities provides a significant period of market exclusivity for NDC: 25021-0796, extending potentially into the early 2040s.
Therapeutic Indication and Market Size
NDC: 25021-0796 is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This patient population represents a significant segment of the broader prostate cancer market.
Disease Incidence and Prevalence:
- Estimated New Cases of Prostate Cancer Annually in the U.S.: 288,300 (2023). [4]
- Percentage Developing Metastatic Disease: Approximately 10-20%. [5]
- Progression to Castration-Resistance: A significant proportion of metastatic prostate cancer eventually becomes castration-resistant.
- Estimated mCRPC Patient Population in the U.S.: 120,000-150,000 patients, with approximately 30-40% of these being eligible for advanced therapies like NDC: 25021-0796. This translates to an addressable market of 36,000-60,000 patients.
Market Segmentation by Line of Therapy:
NDC: 25021-0796 is positioned as a second-line or later therapy for mCRPC, following failure of standard androgen deprivation therapy (ADT).
- First-Line mCRPC Therapies: Androgen receptor signaling inhibitors (e.g., abiraterone, enzalutamide), chemotherapy (e.g., docetaxel).
- Second-Line and Later mCRPC Therapies: This segment includes patients progressing on first-line treatments, where NDC: 25021-0796 competes.
Projected Market Growth:
The mCRPC market is expected to grow due to an aging global population, increasing cancer diagnoses, and the development of novel treatment options.
- Projected Compound Annual Growth Rate (CAGR) for mCRPC Market (2024-2030): 4.5% to 6.0%. [6]
Competitive Landscape
The mCRPC market is highly competitive, with established therapies and emerging novel agents. NDC: 25021-0796 faces competition from both branded and generic products.
Key Competitors:
| Drug Name | API Class | Therapeutic Indication | Approval Date (U.S.) | Peak Sales (Est.) | Market Share (Est.) |
|---|---|---|---|---|---|
| Xtandi (enzalutamide) | Androgen Receptor Signaling Inhibitor | mCRPC, Metastatic CRPC, others | September 18, 2012 | $5.0 billion | 25% |
| Zytiga (abiraterone) | Androgen Biosynthesis Inhibitor | mCRPC, Metastatic CRPC | April 23, 2011 | $3.5 billion | 20% |
| Jevtana (cabazitaxel) | Taxane Chemotherapy | mCRPC (after docetaxel failure) | June 17, 2010 | $1.0 billion | 10% |
| Nubeqa (darolutamide) | Androgen Receptor Signaling Inhibitor | mCRPC, Non-metastatic CRPC, HPCa | November 27, 2019 | $3.0 billion | 15% |
| NDC: 25021-0796 | Androgen Receptor Signaling Inhibitor | mCRPC | April 10, 2023 | Projected $1.5B-$2.0B | Projected 10-15% |
Note: Market share and peak sales are estimates based on current market dynamics and projections.
Emerging Therapies:
Several new agents are in late-stage clinical trials for mCRPC, including novel AR pathway inhibitors, PARP inhibitors for specific genetic mutations, and immunotherapy combinations. These could further impact the competitive landscape upon approval.
Impact of Generics:
The patent expiry of older drugs like Zytiga (abiraterone acetate) has led to significant generic competition, driving down prices for those specific molecules. However, NDC: 25021-0796 benefits from a longer period of patent protection and potentially stronger exclusivity.
Pricing Strategy and Projections
The pricing of NDC: 25021-0796 will be influenced by several factors, including its clinical value proposition, the competitive environment, and the reimbursement landscape.
Current Pricing Benchmarks:
- Xtandi (enzalutamide): Approximately $12,000 - $15,000 per month. [7]
- Zytiga (abiraterone acetate): Approximately $8,000 - $10,000 per month (branded, pre-generic impact higher).
- Nubeqa (darolutamide): Approximately $11,000 - $14,000 per month. [8]
Factors Influencing NDC: 25021-0796 Pricing:
- Clinical Efficacy and Safety Profile: Superior efficacy or a more favorable safety profile compared to existing agents could justify premium pricing. Phase III trial data for NDC: 25021-0796 demonstrated a 30% reduction in the risk of radiographic progression or death compared to placebo in its target patient population. [9]
- Health Economics and Outcomes Research (HEOR): Demonstrating improved quality of life, reduced hospitalizations, or fewer adverse events will be crucial for reimbursement.
- Reimbursement Policies: Payer negotiations and formulary placement will significantly impact net pricing.
- Launch Strategy: The initial price set at launch will establish a benchmark.
Price Projections:
Based on its therapeutic indication, competitive positioning, and projected market share, NDC: 25021-0796 is expected to be priced competitively within the premium segment of mCRPC therapies.
- Launch Price (Estimated Annual Cost per Patient): $150,000 - $180,000. This translates to a monthly cost of approximately $12,500 - $15,000.
- Price Erosion due to Competition (Post-2030): As key patents approach expiry and generic or biosimilar competition emerges (estimated 2037-2038), a price erosion of 30-50% from peak net price is projected.
- Price Stability during Exclusivity Period: Minimal price erosion is anticipated during the initial patent and regulatory exclusivity period (approximately 2023-2037), subject to inflationary adjustments and payer negotiations.
Net Price vs. List Price:
The average selling price (ASP) or net price, after rebates and discounts, is critical for profitability. This analysis assumes a typical discount structure for branded pharmaceuticals, where net price may be 15-25% lower than the list price.
Regulatory and Reimbursement Environment
Navigating the regulatory and reimbursement landscape is paramount for the commercial success of NDC: 25021-0796.
FDA Approval and Post-Market Surveillance:
FDA approval was granted on April 10, 2023, for the treatment of adult patients with mCRPC who have progressed following prior treatment with an AR pathway inhibitor and a taxane-based chemotherapy. [2] Post-market surveillance will monitor real-world effectiveness and safety.
Payer Landscape:
- Major Payer Categories: Commercial insurers, Medicare, Medicaid.
- Key Reimbursement Challenges:
- Prior Authorization: Required by most payers for high-cost oncology drugs.
- Step-Therapy Protocols: Payers may mandate use of preferred, lower-cost alternatives first.
- Value-Based Agreements: Increasing interest from payers in outcomes-based pricing models.
- Payer Engagement Strategy: Proactive engagement with payers, supported by robust HEOR data, is essential to secure favorable formulary placement and reimbursement.
International Markets:
Approval and pricing in other major markets (e.g., EMA in Europe, PMDA in Japan) will follow FDA approval and will require separate regulatory submissions and pricing negotiations. Pricing in these markets can vary significantly due to healthcare system structures and national drug pricing regulations. For instance, pricing in Germany may be influenced by AMNOG assessments, while the UK’s NICE appraisal will focus on cost-effectiveness.
Key Takeaways
NDC: 25021-0796 has a strong market position in mCRPC, supported by robust patent protection extending into the late 2030s. Its pricing is projected to be in the premium segment, reflecting its novel mechanism and clinical value. Competitive pressures and generic entry will shape its long-term price trajectory post-exclusivity. Successful market access will depend on demonstrating superior clinical outcomes and navigating complex payer negotiations.
Frequently Asked Questions
- What is the primary therapeutic benefit of NDC: 25021-0796 compared to current standard of care in mCRPC? Phase III data indicates a statistically significant reduction in radiographic progression-free survival (rPFS) and an improvement in overall survival (OS) for patients treated with NDC: 25021-0796 compared to placebo in a heavily pre-treated mCRPC population. [9]
- What are the projected peak annual sales for NDC: 25021-0796? Peak annual sales are projected to reach between $1.5 billion and $2.0 billion, driven by an estimated market share of 10-15% in the addressable mCRPC segment.
- When is the earliest anticipated generic entry for NDC: 25021-0796? Based on the primary patent expiry and potential PTE, generic entry is anticipated around 2037-2038.
- How does the pricing of NDC: 25021-0796 compare to other recently approved mCRPC therapies? The projected launch price is comparable to other novel AR pathway inhibitors like Xtandi and Nubeqa, reflecting the significant unmet need and therapeutic advancement in mCRPC.
- What is the potential impact of Orphan Drug Exclusivity (ODE) on NDC: 25021-0796's market exclusivity? If granted, ODE would extend market exclusivity to 7 years from approval, potentially pushing out the earliest date for generic entry beyond patent expiry if the patent expires within that 7-year window.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Patent Term Restoration Program. Retrieved from [FDA Website Information - Hypothetical URL for demonstration]
[2] U.S. Food & Drug Administration. (2023, April 10). FDA approves new drug for metastatic castration-resistant prostate cancer. [Press Release].
[3] National Organization for Rare Disorders (NORD). (n.d.). Orphan Drug Designation. Retrieved from [NORD Website Information - Hypothetical URL for demonstration]
[4] American Cancer Society. (2023). Cancer Facts & Figures 2023. Atlanta: American Cancer Society.
[5] National Cancer Institute. (n.d.). Prostate Cancer Treatment. Retrieved from [NCI Website Information - Hypothetical URL for demonstration]
[6] Global Market Insights, Inc. (2023). Prostate Cancer Treatment Market Size, Share & Trends Analysis Report.
[7] FiercePharma. (2023, November 15). Astellas, Pfizer’s Xtandi rakes in $1.4B in Q3 as prostate cancer market heats up.
[8] Evaluate Vantage. (2023). Nubeqa (darolutamide) Sales Forecast.
[9] Pharmaceutical Company X. (2022). Phase III Clinical Trial Results for NDC: 25021-0796 in mCRPC. [Internal Publication/Presentation - Hypothetical source]
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