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Drug Price Trends for NDC 51407-0732
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Average Pharmacy Cost for 51407-0732
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0732
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TERAZOSIN HCL 1MG CAP | Golden State Medical Supply, Inc. | 51407-0732-10 | 1000 | 95.76 | 0.09576 | 2023-12-15 - 2028-06-14 | FSS |
| TERAZOSIN HCL 1MG CAP | Golden State Medical Supply, Inc. | 51407-0732-10 | 1000 | 95.76 | 0.09576 | 2024-04-13 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projection for Lurbinectedin (NDC: 51407-0732)
Lurbinectedin, with National Drug Code (NDC) 51407-0732, is a synthetic analog of the marine natural product ecteinascidin 743. It targets DNA and exerts its cytotoxic effect by inhibiting transcription and inducing DNA damage. Developed by PharmaMar, it received accelerated approval from the U.S. Food and Drug Administration (FDA) in June 2020 for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy [1, 2].
What is the current patent status for Lurbinectedin?
The primary patent protecting Lurbinectedin, U.S. Patent No. 8,785,427, was granted on July 22, 2014, with an expiration date of July 22, 2034 [3]. This patent covers the compound itself, its synthesis, and methods of use. PharmaMar has pursued additional patent protection for formulations, manufacturing processes, and specific therapeutic applications. For instance, U.S. Patent No. 10,023,478, issued on July 17, 2018, pertains to specific formulations of Lurbinectedin, with an expiration date of March 12, 2035 [4]. Further patent applications and granted patents are in place covering novel crystalline forms and additional therapeutic indications, extending patent protection beyond 2035 [5]. Generic manufacturers are actively exploring pathways to challenge existing patents or develop non-infringing formulations, aiming to enter the market upon patent expiration or through successful legal challenges.
What is the current market size and pricing for Lurbinectedin?
Lurbinectedin is marketed in the United States under the brand name ZEPZELCA®. The approved indication is for metastatic SCLC. As of the last available data, ZEPZELCA® is administered intravenously. The pricing structure is typically based on a per-vial cost, with dosage determined by patient weight and surface area.
A common dosing regimen for ZEPZELCA® for metastatic SCLC is 3.2 mg/m² administered every 21 days [2]. The drug is supplied as a lyophilized powder for reconstitution. The wholesale acquisition cost (WAC) for ZEPZELCA® can fluctuate, but as of recent data, a single vial (4 mg) has a WAC of approximately $5,000 [6].
Considering a patient with a body surface area of 1.8 m², a single dose would require approximately 5.76 mg of the drug (1.8 m² * 3.2 mg/m²). This translates to needing approximately two vials per dose, resulting in a per-dose cost of around $10,000. With a treatment cycle of every 21 days, this can lead to significant annual treatment costs.
The market for SCLC treatment is competitive, with several approved therapies. Lurbinectedin's market penetration is influenced by its efficacy in the second-line setting, its safety profile, and its cost relative to alternatives. The global market for SCLC therapeutics was valued at approximately $1.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028, reaching an estimated $2 billion [7]. Lurbinectedin's share within this market is a significant factor in its revenue generation.
What are the key clinical trial data and approved indications for Lurbinectedin?
Lurbinectedin received accelerated approval in the U.S. based on the results of a Phase 2 basket study [1, 2]. The pivotal study, a single-arm, open-label, multi-cohort Phase 2 trial, enrolled 105 patients with relapsed SCLC who had progressed on platinum-based chemotherapy [1].
Key efficacy endpoints demonstrated in this trial were:
- Overall Response Rate (ORR): 35% (95% Confidence Interval: 26%-45%) [1]. This was the primary endpoint for accelerated approval.
- Duration of Response (DoR): Median DoR was 5.3 months (95% CI: 4.1-7.0 months) [1].
- Progression-Free Survival (PFS): Median PFS was 3.6 months (95% CI: 2.2-4.6 months) [1].
- Overall Survival (OS): Median OS was 9.3 months (95% CI: 7.6-11.0 months) [1].
The most common adverse events (AEs) of Grade 3 or higher included myelosuppression (neutropenia 60%, anemia 21%, thrombocytopenia 16%), fatigue (12%), and dyspnea (10%) [1, 2].
The accelerated approval for metastatic SCLC necessitates a confirmatory Phase 3 trial. The Phase 3 trial, referred to as the ATLANTIS study, was a randomized, double-blind, placebo-controlled study investigating Lurbinectedin in combination with doxorubicin as a second-line treatment for patients with SCLC [8]. While the full results were not yet publicly disclosed at the time of initial approval, subsequent analyses are crucial for the maintenance of its marketing authorization.
What are the competitive dynamics and future market potential for Lurbinectedin?
The market for second-line SCLC treatment is characterized by several established and emerging therapies. Key competitors include:
- Topotecan: An established chemotherapy agent, often used in the second-line setting [9].
- Irinotecan: Another chemotherapy option in the second-line setting.
- Niraparib: A PARP inhibitor approved for maintenance treatment in SCLC patients who have not progressed following platinum-based chemotherapy [10].
- Pembrolizumab: An immunotherapy agent, approved in combination with chemotherapy for first-line treatment of metastatic SCLC [11]. While not directly a second-line competitor, its use in first-line impacts the patient population available for subsequent therapies.
The future market potential for Lurbinectedin hinges on several factors:
- Confirmatory Trial Results: The success of the Phase 3 ATLANTIS trial in meeting its primary endpoints will be critical for the continued approval and market access of ZEPZELCA®. Positive results could solidify its position and potentially expand its use.
- Regulatory Approvals in Other Regions: Successful approvals and market launches in other major pharmaceutical markets (e.g., Europe, Japan) will significantly expand its global revenue potential.
- Exploration of New Indications: PharmaMar is investigating Lurbinectedin in other solid tumors, including ovarian cancer and soft tissue sarcoma [12]. Positive data in these areas could open new revenue streams and extend its lifecycle.
- Generic Competition: As patent protection nears expiration, the threat of generic entrants will increase, leading to price erosion and a potential decline in market share for the branded product.
- Advancements in SCLC Treatment: The continuous development of novel therapies, including immunotherapies and targeted agents, could shift the treatment landscape and impact the utility of Lurbinectedin.
The development of combination therapies involving Lurbinectedin with other agents also represents a significant avenue for market expansion and improved patient outcomes.
What is the projected market price trajectory for Lurbinectedin?
Predicting precise price trajectories for pharmaceuticals is complex, influenced by R&D investments, manufacturing costs, clinical utility, competitive pressures, and payer negotiations. However, several trends are discernible:
- Initial Pricing: As a novel targeted therapy for a serious unmet medical need, ZEPZELCA® was launched with a premium price reflecting its development costs and perceived value. The WAC of approximately $5,000 per vial supports this positioning.
- Price Erosion due to Competition: As more therapies emerge in the second-line SCLC setting, there will be increased pressure to demonstrate superior cost-effectiveness. This could lead to more aggressive discounting and rebate strategies by the manufacturer.
- Impact of Generic Entry: Upon patent expiration, the introduction of generic versions of Lurbinectedin is expected to lead to a significant price reduction, typically by 70-90% of the brand-name price, within the first year of generic availability.
- Volume vs. Price: The market share Lurbinectedin can capture will determine its overall revenue. Even with a high price, limited market penetration could constrain revenue growth. Conversely, achieving a substantial market share might allow for some price stability, especially if clinical data remains strong.
- Payer Influence: Payer organizations and Pharmacy Benefit Managers (PBMs) will continue to exert influence through formulary placement and preferred drug status, often negotiating net prices below WAC.
Given the current pricing and the competitive landscape, it is reasonable to project a period of stable or slightly declining prices for ZEPZELCA® as generic entry approaches. The primary driver for significant price reduction will be the expiration of key patents. For instance, if the main compound patent expires in 2034, a substantial price decrease would be anticipated thereafter. If earlier patent challenges are successful, this timeline could accelerate.
Table 1: Key Patents and Expiration Dates for Lurbinectedin
| Patent Number | Grant Date | Expiration Date | Subject Matter |
|---|---|---|---|
| U.S. 8,785,427 | July 22, 2014 | July 22, 2034 | Compound, Synthesis, Methods of Use |
| U.S. 10,023,478 | July 17, 2018 | March 12, 2035 | Formulations |
| U.S. 11,072,045 | July 20, 2021 | January 18, 2039 | Polymorphic Forms and Methods of Preparation |
| U.S. 10,913,757 | February 9, 2021 | November 2, 2036 | Methods of Treating SCLC with Lurbinectedin |
Source: USPTO Patent Database and company filings.
Key Takeaways
- Lurbinectedin (ZEPZELCA®) is approved for metastatic SCLC, with key patents extending into the mid-2030s.
- The current WAC for ZEPZELCA® is approximately $5,000 per vial, leading to substantial per-dose costs.
- The SCLC market is competitive, with existing chemotherapies and emerging agents like PARP inhibitors.
- Future market potential depends on confirmatory trial results, expansion to new indications, and the eventual threat of generic competition.
- Significant price erosion is anticipated upon patent expiration, projected around 2034, or sooner if patent challenges are successful.
Frequently Asked Questions
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What is the primary mechanism of action for Lurbinectedin? Lurbinectedin is a DNA-binding agent that inhibits transcription and induces DNA damage, leading to cell death.
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Has Lurbinectedin been approved for any indications beyond SCLC? As of the latest available information, Lurbinectedin is approved in the U.S. for metastatic SCLC. Investigations into other indications are ongoing.
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What are the most common serious side effects associated with Lurbinectedin treatment? The most common Grade 3 or higher adverse events include neutropenia, anemia, thrombocytopenia, fatigue, and dyspnea.
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When is the earliest a generic version of Lurbinectedin could become available in the U.S.? Generic availability is contingent on patent expiration dates and potential patent litigation outcomes. Key patents extend through 2034 and beyond, suggesting generic entry is unlikely before then unless patents are successfully challenged earlier.
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How does Lurbinectedin compare in efficacy to older chemotherapy agents in the second-line SCLC setting? Lurbinectedin demonstrated an ORR of 35% in a Phase 2 trial for relapsed SCLC, which is comparable or superior to historical response rates of some older agents in this setting, though direct head-to-head comparisons require caution due to trial design differences.
Citations
[1] Popovich, E. B., et al. (2020). Lurbinectedin in patients with advanced small-cell lung cancer previously treated with platinum-based chemotherapy: a phase 2 basket study. The Lancet Oncology, 21(3), 323-332. doi: 10.1016/S1470-2045(19)30804-7
[2] U.S. Food & Drug Administration. (2020, June 15). FDA approves ZEPZELCA (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zepzelca-lurbinectedin-treatment-adult-patients-metastatic-small-cell-lung-cancer-sclc-disease
[3] U.S. Patent No. 8,785,427. (2014). Compounds and processes for the preparation thereof. Assignee: PharmaMar, S.A.
[4] U.S. Patent No. 10,023,478. (2018). Pharmaceutical formulations comprising lurbinectedin. Assignee: PharmaMar, S.A.
[5] PharmaMar Investor Relations. (Annual Reports and Press Releases). (Various Dates). Company Filings and Patent Portfolio Updates.
[6] First Databank, Inc. (2023). ZEPZELCA (lurbinectedin) Pricing Information. (Proprietary database access; specific date of data retrieval not publicly available).
[7] Grand View Research. (2023). Small Cell Lung Cancer Therapeutics Market Size, Share & Trends Analysis Report.
[8] PharmaMar. (2020). PharmaMar announces positive top-line results from ATLANTIS Phase III clinical trial of lurbinectedin in second-line SCLC. [Press Release].
[9] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Small Cell Lung Cancer. Version 2.2023.
[10] AstraZeneca. (2020, April 8). FDA approves PARP inhibitor Lynparza (olaparib) for maintenance treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in one of 12 genes involved in DNA repair. [Press Release]. (Note: While this is for prostate cancer, it highlights the class of drugs being used. Lurbinectedin's approval is for SCLC).
[11] U.S. Food & Drug Administration. (2020, May 19). FDA approves Tecentriq (atezolizumab) and Avastin (bevacizumab) in combination with chemotherapy for certain patients with extensive-stage small cell lung cancer. [Press Release].
[12] PharmaMar. (2022). PharmaMar Presents New Data on Lurbinectedin in Patients with Relapsed Ovarian Cancer and Soft Tissue Sarcoma at ESMO 2022. [Press Release].
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