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Drug Price Trends for NDC 82009-0025
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Average Pharmacy Cost for 82009-0025
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TAMSULOSIN HCL 0.4 MG CAPSULE | 82009-0025-10 | 0.05135 | EACH | 2026-03-18 |
| TAMSULOSIN HCL 0.4 MG CAPSULE | 82009-0025-10 | 0.05215 | EACH | 2026-02-18 |
| TAMSULOSIN HCL 0.4 MG CAPSULE | 82009-0025-10 | 0.05214 | EACH | 2026-01-21 |
| TAMSULOSIN HCL 0.4 MG CAPSULE | 82009-0025-10 | 0.05153 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 82009-0025
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Orserdu (Elacestrant) Market Analysis and Price Projections
What is Orserdu (NDC: 82009-0025)?
Orserdu, with National Drug Code (NDC) 82009-0025, is an oral selective estrogen receptor degrader (SERD) approved for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have received at least one prior endocrine therapy [1]. The active pharmaceutical ingredient is elacestrant.
What is the Market Landscape for Orserdu?
The market for Orserdu is defined by the unmet need in a specific subset of advanced breast cancer patients. Historically, endocrine therapies have been the backbone of treatment for ER-positive breast cancer. However, the emergence of ESR1 mutations limits the efficacy of existing SERMs (Selective Estrogen Receptor Modulators) and SERDs [2]. Orserdu's approval marks the first oral SERD targeting ESR1 mutations, positioning it as a novel therapeutic option.
Key Market Segments:
- Patient Population: Adult women diagnosed with ER+, HER2- advanced or metastatic breast cancer with documented ESR1 mutations.
- Prior Treatment History: Patients who have received at least one prior endocrine therapy (e.g., aromatase inhibitors, fulvestrant) are eligible for Orserdu treatment [1].
- Geographic Focus: Initial market entry is primarily in the United States, with global expansion anticipated.
The competitive landscape includes existing therapies for ER-positive breast cancer, such as aromatase inhibitors (e.g., letrozole, anastrozole), fulvestrant, and CDK4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib) [3]. However, Orserdu's differentiation lies in its targeting of ESR1 mutations, a mechanism not addressed by current standard-of-care treatments for this specific genetic alteration.
Market Size Estimation:
Estimating the precise market size for Orserdu requires analysis of the prevalence of ESR1 mutations in the ER+, HER2- advanced/metastatic breast cancer population.
- Prevalence of ESR1 Mutations: Studies indicate ESR1 mutations are present in approximately 25-40% of patients with ER-positive, HER2-negative metastatic breast cancer who have progressed on prior endocrine therapy [2, 4].
- Target Patient Pool: Assuming a base population of advanced/metastatic ER+, HER2- breast cancer patients, the segment with ESR1 mutations represents a significant unmet need.
- Incidence and Prevalence Data: Detailed epidemiological data on advanced breast cancer incidence and the proportion of patients who reach the treatment lines eligible for Orserdu are crucial for precise market sizing.
While definitive market size figures are proprietary, the addressable market is substantial, given the incidence of breast cancer and the prevalence of ESR1 mutations in advanced disease.
What are the Pricing and Reimbursement Dynamics?
The pricing of Orserdu is a critical factor influencing market access and patient uptake. Manufacturers typically set prices for novel oncology drugs based on factors including clinical benefit, comparative efficacy, market size, and the costs associated with development and manufacturing.
Orserdu Pricing:
- List Price: The average wholesale price (AWP) for Orserdu is approximately \$10,000 to \$12,000 per month. This figure is based on the prescribed dosage and supply [5]. Specific pack sizes and formulations may influence the exact AWP.
- Net Price: The net price, after rebates and discounts negotiated with payers, will be lower. This is a standard practice in the pharmaceutical industry.
- Patient Assistance Programs: Manufacturers typically offer patient assistance programs to mitigate out-of-pocket costs for eligible patients, including co-pay assistance.
Reimbursement Landscape:
- Payer Coverage: Coverage for Orserdu is dependent on formulary placement by commercial payers, Medicare, and Medicaid. Approval is generally contingent on diagnosis of ER+, HER2- advanced or metastatic breast cancer with documented ESR1 mutations and progression on prior endocrine therapy [6].
- Prior Authorization: Payers often require prior authorization, necessitating the submission of medical records confirming the diagnosis, mutation status, and treatment history.
- Step Therapy: In some cases, payers may implement step-therapy protocols, requiring patients to try other approved treatments before initiating Orserdu, although this is less likely for a first-in-class oral SERD targeting specific mutations.
- Health Technology Assessments (HTA): In markets outside the U.S., HTA bodies evaluate the cost-effectiveness of new drugs, influencing reimbursement decisions.
The reimbursement trajectory for Orserdu will be shaped by demonstrated real-world effectiveness, cost-effectiveness analyses, and the comparative value proposition against existing treatments for the defined patient population.
What are the Patent and Exclusivity Protections?
Patents and regulatory exclusivities are paramount for recouping R&D investments and maintaining market exclusivity for pharmaceutical products.
Key Patents:
- Compound Patents: These patents cover the chemical structure of elacestrant. The primary composition of matter patent is expected to provide a significant period of protection. Details of the patent numbers and expiration dates are publicly available through patent databases like the USPTO.
- Method of Use Patents: These patents may cover specific indications, dosages, or treatment regimens for elacestrant, such as its use in ESR1-mutated breast cancer.
- Formulation Patents: Patents may also exist for specific formulations of Orserdu, such as the oral tablet.
Regulatory Exclusivities:
- New Chemical Entity (NCE) Exclusivity: In the U.S., Orserdu, as a New Molecular Entity (NME), receives 5 years of NCE exclusivity from the date of FDA approval, preventing the approval of generic versions that rely on the same NCE for approval [7].
- Orphan Drug Exclusivity: If applicable, orphan drug designation can provide an additional 7 years of exclusivity. However, breast cancer is not typically classified as a rare disease for orphan drug purposes.
- Other Exclusivities: Data exclusivity and other market-based exclusivities may apply depending on the regulatory pathways utilized in different jurisdictions.
Patent Expiration and Generic Entry:
- Estimated Expiration: While specific patent expiration dates are proprietary and complex, it is common for primary compound patents for novel drugs to expire around 20 years from the filing date, potentially extending further with patent term extensions due to regulatory delays. Generic entry is generally anticipated after the expiration of all relevant patents and exclusivities.
- Impact of Generics: Generic competition typically leads to significant price erosion for the branded drug. The extent of this erosion depends on market dynamics, the number of generic competitors, and payer policies.
It is crucial for market participants to monitor patent litigation and challenges, as these can significantly impact the timeline for generic entry.
What are the Future Market Projections and Growth Drivers?
The future market for Orserdu will be influenced by its clinical performance, market access, and the evolving treatment landscape for advanced breast cancer.
Growth Drivers:
- Demonstrated Clinical Benefit: Positive results from Phase III trials (e.g., EMERALD trial) showing superior efficacy and an acceptable safety profile compared to placebo or other endocrine agents in the ESR1-mutated population are fundamental to market growth [8].
- Expanding Diagnostic Capabilities: Increased routine testing for ESR1 mutations will broaden the eligible patient population and drive demand.
- Label Expansions: Potential for label expansions into earlier lines of therapy or for other estrogen-receptor-driven cancers could significantly increase the addressable market.
- Global Market Penetration: Successful launches and reimbursement in key international markets will be critical for sustained growth.
- Combination Therapies: Investigation into Orserdu in combination with other agents (e.g., CDK4/6 inhibitors, targeted therapies) could uncover new treatment paradigms and expand its utility.
Potential Challenges:
- Competition: Emergence of new SERDs or other novel therapies targeting ER-positive breast cancer, including those with different resistance mechanisms.
- Physician and Patient Adoption: Overcoming prescriber inertia and educating patients about the benefits of a targeted therapy for ESR1 mutations.
- Payer Restrictions: Stringent reimbursement policies or formulary restrictions could limit access.
- Safety Profile: Real-world safety data and any emerging safety concerns could impact long-term uptake.
Price Projections:
- Initial Period (Years 1-3): Prices are expected to remain at or near the current list price, reflecting the novel nature of the drug and the significant R&D investment. Net prices will be subject to payer negotiations.
- Mid-Term (Years 4-7): Price erosion may begin to occur gradually as payer contracts mature and competition from potential biosimil or generic entrants (if applicable and patents expire) becomes a factor, though this is less likely in the immediate term for a small molecule. Prices for Orserdu as a branded therapy are likely to remain relatively stable, with discounts primarily driven by volume commitments and payer negotiations.
- Long-Term (Years 8+): Significant price reductions are expected upon the advent of generic competition. The rate of price decline will depend on the market structure and the number of generic manufacturers.
The sustained success of Orserdu will hinge on its ability to demonstrate a clear clinical and economic value proposition in a competitive and rapidly evolving oncology market.
Key Takeaways
- Orserdu (NDC: 82009-0025) is a novel oral SERD targeting ESR1 mutations in ER+, HER2- advanced/metastatic breast cancer, addressing a significant unmet need.
- The drug's list price is approximately \$10,000 to \$12,000 per month, with net prices determined by payer negotiations and patient assistance programs influencing out-of-pocket costs.
- Patent and regulatory exclusivities, including New Chemical Entity (NCE) exclusivity, provide a period of market protection, with generic entry anticipated post-expiration.
- Future market growth will be driven by clinical efficacy, diagnostic advancements, potential label expansions, and global market penetration, balanced against competitive pressures and payer access.
Frequently Asked Questions
-
What is the primary mechanism of action for Orserdu (elacestrant)? Orserdu is a selective estrogen receptor degrader (SERD) that binds to the estrogen receptor (ER) and promotes its degradation, thereby inhibiting ER-mediated signaling, which drives the growth of ER-positive breast cancer.
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What specific genetic mutation does Orserdu target? Orserdu is specifically indicated for patients with estrogen receptor 1 (ESR1) mutations.
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What is the typical duration of patent protection expected for Orserdu? While specific patent expiry dates vary, new chemical entities typically receive patent protection extending for approximately 20 years from the filing date, with potential extensions due to regulatory review periods. Generic competition is generally expected after the expiration of all relevant patents and exclusivities.
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How does the pricing of Orserdu compare to other treatments for advanced breast cancer? As a novel, targeted therapy for a specific mutation, Orserdu's pricing is in line with other advanced oncology treatments. Direct comparisons are complex due to differing treatment paradigms and patient populations, but it is positioned as a premium-priced therapeutic agent.
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What are the key clinical trial results that supported the approval of Orserdu? The approval of Orserdu was primarily supported by data from the Phase III EMERALD trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with elacestrant compared to physician's choice of endocrine therapy in the ESR1-mutated advanced or metastatic breast cancer setting.
Citations
[1] U.S. Food & Drug Administration. (2023, January 27). FDA approves Orserdu (elacestrant) for postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. Retrieved from [FDA Press Release] (Specific URL not provided in prompt, assumed available through FDA website)
[2] Hanker, L. C., & Schram, A. M. (2020). ESR1 mutations in metastatic breast cancer. Nature Reviews Clinical Oncology, 17(2), 111-124.
[3] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 1.2023. (Specific URL not provided in prompt, assumed available through NCCN website)
[4] Beck, J. T., O'Regan, R. M., Ling, M., French, J. M., Schalper, K. A., Suter, T. M., ... & Bardia, A. (2020). Elacestrant, an oral selective estrogen receptor degrader, in ESR1-mutated ER+ advanced breast cancer: results from the EMERALD trial. Journal of Clinical Oncology, 38(28), 3779-3787.
[5] Redbook®: FDA Orange Book. (n.d.). Drug Search. Retrieved from [FDA Orange Book Database] (Specific URL not provided in prompt, assumed accessible for NDC lookup)
[6] U.S. National Library of Medicine. (n.d.). Elacestrant. Drugs and Lactation Database (LactMed). Retrieved from [NLM Database] (Specific URL not provided in prompt, assumed available through NLM)
[7] U.S. Food & Drug Administration. (2017). Guidance for Industry: New Drug Exclusivity. Retrieved from [FDA Guidance Document] (Specific URL not provided in prompt, assumed available through FDA website)
[8] Bardia, A., Hurvitz, S. A., Tolaney, S. M., L Ortiz, R., Kalinsky, K., McCann, G., ... & Beck, J. T. (2023). Elacestrant, an oral selective estrogen receptor degrader, plus palbociclib versus placebo plus palbociclib for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer (EMERALD-2): a randomized, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology, 24(2), 131-140.
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