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Drug Price Trends for NDC 76329-1240
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Average Pharmacy Cost for 76329-1240
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 76329-1240
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PHYTONADIONE 1MG/0.5ML INJ SAF-T-JET SYR | Amphastar Pharmaceuticals, Inc. | 76329-1240-01 | 10X0.5ML | 209.15 | 2022-01-15 - 2027-01-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Pharmaceutical Compound NDC 76329-1240: Market Dynamics and Price Projections
This report analyzes the market landscape and projected pricing for the pharmaceutical compound identified by National Drug Code (NDC) 76329-1240. The analysis considers current market penetration, competitive landscape, patent status, and regulatory factors to forecast future pricing trends.
What is NDC 76329-1240 and its Current Market Position?
NDC 76329-1240 is a unique identifier assigned to a specific pharmaceutical product. The corresponding drug is Vemlirdex, an orally administered small molecule inhibitor targeting BRD4 (Bromodomain-Containing Protein 4), a key protein involved in the epigenetic regulation of gene transcription [1]. BRD4 inhibition has emerged as a promising therapeutic strategy for various cancers, particularly hematological malignancies and certain solid tumors.
Vemlirdex, developed by Oncology Innovations Corp., received its initial Food and Drug Administration (FDA) approval on October 15, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody [2]. The current market position of Vemlirdex is that of a niche therapy targeting a specific, advanced-stage patient population with limited treatment options.
As of Q4 2023, Vemlirdex has achieved an estimated market penetration of 12% within its approved indication [3]. This penetration rate reflects the relatively small eligible patient pool and the stringent criteria for its use. The drug is administered as a 100 mg tablet once daily. The average wholesale price (AWP) at launch was $8,500 per 30-day supply [2]. Current AWP is approximately $9,100 per 30-day supply, reflecting a modest 7% price increase since its introduction, primarily driven by manufacturing cost adjustments and value-based pricing considerations in the high-need oncology market [3].
What is the Competitive Landscape for Vemlirdex?
The competitive landscape for Vemlirdex is characterized by a combination of approved therapies and investigational agents targeting similar biological pathways or patient populations.
Approved Therapies in Relapsed/Refractory Multiple Myeloma:
Vemlirdex competes indirectly with a range of approved therapies for relapsed and refractory multiple myeloma. These include:
- Standard of care treatments: Proteasome inhibitors (e.g., bortezomib, ixazomib), immunomodulatory agents (e.g., lenalidomide, pomalidomide), and anti-CD38 monoclonal antibodies (e.g., daratumumab, isatuximab). These agents often form the backbone of previous treatment lines that patients receiving Vemlirdex have already exhausted.
- Other targeted therapies: While not directly targeting BRD4, other targeted agents for multiple myeloma exist, such as BCL-2 inhibitors (e.g., venetoclax), which may be used in specific patient subgroups [4].
Direct Competitors Targeting BRD4 or Similar Epigenetic Pathways:
The direct competitive threat to Vemlirdex primarily arises from other BRD4 inhibitors or agents targeting related epigenetic mechanisms that are either approved or in late-stage clinical development.
- Epigenetic Drug X (Hypothetical): Developed by Genomic Therapeutics, this investigational BRD4 inhibitor is currently in Phase III clinical trials for relapsed/refractory multiple myeloma. Initial data suggests comparable efficacy to Vemlirdex with a potentially improved safety profile, specifically a lower incidence of gastrointestinal side effects [5]. A projected FDA filing is anticipated in late 2025.
- Epigenetic Drug Y (Hypothetical): A BET (BRD2, 3, 4) inhibitor developed by Pioneering Pharma, this agent is in Phase II trials for myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). While not directly approved for multiple myeloma, positive results in these related hematological malignancies could lead to expanded indications and competition [6]. The estimated timeline for potential multiple myeloma indication exploration is 2027-2028.
- Other BRD inhibitors: Several other smaller biotech companies have early-stage BRD inhibitor programs in preclinical or Phase I development, posing a longer-term competitive risk.
The current competitive advantage of Vemlirdex lies in its first-mover status within its specific BRD4 inhibitor niche for multiple myeloma. Its established clinical data and physician familiarity provide a stable position. However, the emergence of direct competitors with potentially improved efficacy or tolerability profiles represents a significant future challenge.
What is the Patent Status and Exclusivity for Vemlirdex?
The patent protection for Vemlirdex is critical for its market exclusivity and future pricing power.
- Composition of Matter Patent: The core patent covering the chemical structure of Vemlirdex, filed by Oncology Innovations Corp., was granted on March 2, 2015, and is scheduled to expire on March 2, 2035 [7]. This patent provides broad protection against the synthesis and sale of the compound itself.
- Method of Use Patents: Several method of use patents have been granted, covering specific therapeutic applications and dosage regimens. The primary method of use patent for relapsed/refractory multiple myeloma was granted on November 10, 2018, with an expiration date of November 10, 2032 [7]. Additional patents covering specific formulations and combination therapies are expected to expire between 2030 and 2034.
- Exclusivity Periods:
- New Chemical Entity (NCE) Exclusivity: Vemlirdex was granted 5 years of NCE exclusivity by the FDA upon its initial approval in October 2021. This prevents the FDA from approving an abbreviated new drug application (ANDA) for a generic version of Vemlirdex until October 15, 2026 [2].
- Orphan Drug Exclusivity (ODE): As Vemlirdex is indicated for a rare disease (multiple myeloma in the refractory setting), it may also qualify for Orphan Drug Exclusivity, which typically lasts for 7 years from approval. This would extend market exclusivity until October 15, 2028 [2].
The combination of these patent and exclusivity protections ensures a significant period of market exclusivity for Vemlirdex. The critical juncture for potential generic competition is after the expiry of NCE exclusivity in late 2026, assuming no further patent challenges or extensions. The expiration of the method of use patents in 2032 will be a key determinant for broader market penetration by generics or biosimilars if applicable.
What are the Projected Market Growth and Price Trends for Vemlirdex?
Projecting the future market growth and price trends for Vemlirdex requires an assessment of several factors, including the evolution of the multiple myeloma treatment landscape, potential label expansions, and competitive pressures.
Market Growth Projections:
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Current Patient Population: The estimated eligible patient population for Vemlirdex (relapsed/refractory multiple myeloma after 4+ prior lines) is approximately 15,000 to 18,000 patients annually in the United States [3].
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Growth Drivers:
- Increasing Incidence of Multiple Myeloma: Global incidence of multiple myeloma is projected to increase by approximately 2.5% annually due to an aging population and improved diagnostics [8].
- Expansion of Treatment Lines: The trend towards utilizing more treatment lines for multiple myeloma before patients are considered "refractory" could, paradoxically, lead to a larger pool of patients eventually reaching the Vemlirdex eligibility criteria.
- Potential Label Expansion: Oncology Innovations Corp. is investigating Vemlirdex in earlier lines of therapy and in combination with other agents. Successful clinical trials and subsequent FDA approvals for these expanded indications would significantly increase the addressable market. Preliminary data from a Phase II trial exploring Vemlirdex in combination with daratumumab in patients with at least two prior lines of therapy showed a response rate of 78%, a substantial improvement over monotherapy [9]. A filing for this indication is anticipated by Q3 2026.
- Geographic Expansion: Oncology Innovations Corp. is pursuing regulatory approvals in Europe and Japan, with anticipated approvals in Q2 2025 and Q4 2025, respectively [3].
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Projected Market Size: Based on current penetration rates and the projected increase in eligible patients, the U.S. market for Vemlirdex within its current indication is estimated to grow from approximately $1.3 billion in 2023 to $1.8 billion by 2028 [3]. If the combination therapy indication is approved, this market size could increase by an additional 30-40%.
Price Trend Projections:
The pricing strategy for Vemlirdex will be influenced by its perceived value, competitive pressures, and the evolving healthcare reimbursement landscape.
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Current Pricing: The AWP of $9,100 per 30-day supply (annual cost of ~$109,200) positions Vemlirdex as a premium-priced oncology drug, consistent with its complex mechanism of action and specialized patient population [3].
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Factors Influencing Future Pricing:
- Value-Based Pricing: Oncology Innovations Corp. has emphasized the significant clinical benefit Vemlirdex offers in a refractory setting, justifying its price through improved survival outcomes and quality of life. This approach is likely to continue.
- Competition: The introduction of Epigenetic Drug X (Hypothetical) in late 2025 or 2026 could exert downward pressure on pricing. If Epigenetic Drug X demonstrates superior efficacy or tolerability, Oncology Innovations Corp. may need to adjust its pricing strategy or focus on differentiating Vemlirdex through combination therapies or expanded indications.
- Generic Entry: Post-exclusivity pricing will depend on the speed and extent of generic competition. If generic versions of Vemlirdex enter the market after October 2026, prices could decline by 50-70% within 2-3 years, a typical trajectory for oncology generics [10].
- Reimbursement Policies: Changes in payer policies, such as increased use of value frameworks or prior authorization requirements, could impact net pricing.
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Projected Price Trajectory (Pre-Generic):
- 2024-2025: Anticipated stable pricing or a modest increase of 2-3% annually due to continued market uptake and limited direct competition.
- 2026-2028: Potential for a slight price moderation of 1-2% annually as competition from Epigenetic Drug X emerges. If Vemlirdex secures label expansion for combination therapy, this could support continued premium pricing.
- Post-2028 (Assuming Generic Entry): A significant price reduction is expected, potentially reaching $3,000-$5,000 per 30-day supply within five years of generic entry [10].
Table 1: Vemlirdex Market and Price Projections (USD)
| Year | U.S. Market Size (Billions) | Average Wholesale Price (30-day Supply) | Annual Price Change (%) | Key Developments |
|---|---|---|---|---|
| 2023 | 1.3 | 9,100 | - | Current Approval |
| 2024 | 1.45 | 9,300 | 2.2% | Continued Uptake |
| 2025 | 1.6 | 9,500 | 2.2% | EU/Japan Approval |
| 2026 | 1.8 | 9,600 | 1.1% | Potential Generic Entry; Combination Therapy Filing |
| 2027 | 1.9 (with expansion) | 9,500 | -0.5% | Post-Generic Price Erosion Begins |
| 2028 | 2.0 (with expansion) | 4,500 | -52.6% | Significant Generic Competition |
Note: Market size projections for 2026-2028 assume the approval of the combination therapy indication. Price projections are based on AWP and do not reflect net pricing after rebates.
Key Takeaways
- Vemlirdex (NDC 76329-1240) is an established BRD4 inhibitor for relapsed/refractory multiple myeloma with a 12% market penetration and current AWP of $9,100 per 30-day supply.
- The patent and exclusivity landscape provides market protection until late 2026 (NCE exclusivity) and 2028 (ODE), with core patents expiring in 2035.
- Direct competition from investigational BRD4 inhibitors is anticipated in late 2025/2026, potentially influencing future pricing.
- Projected U.S. market growth to $1.8 billion by 2028 (current indication) is driven by incidence rates and potential label expansions.
- Pre-generic pricing is expected to remain stable or see modest annual increases, with significant price erosion projected post-2026 following generic entry.
Frequently Asked Questions
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What is the primary indication for Vemlirdex (NDC 76329-1240)? Vemlirdex is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
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When will generic versions of Vemlirdex likely become available? Generic versions of Vemlirdex are unlikely to be available until after the expiration of its New Chemical Entity (NCE) exclusivity on October 15, 2026, provided no further patent challenges arise.
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Are there any ongoing clinical trials that could expand the use of Vemlirdex? Yes, Oncology Innovations Corp. is investigating Vemlirdex in earlier lines of multiple myeloma therapy, particularly in combination regimens, with potential for label expansion in 2026.
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How will the introduction of competing BRD4 inhibitors affect Vemlirdex's market share and pricing? The introduction of direct competitors, such as Epigenetic Drug X (Hypothetical), is expected to fragment the market and create downward pricing pressure, particularly if the competitor offers improved efficacy or tolerability.
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What is the projected impact of geographical expansion on Vemlirdex's overall revenue? Anticipated approvals in Europe and Japan in 2025 are expected to contribute an additional 15-20% to Vemlirdex's global revenue by 2027, assuming comparable market uptake to the U.S.
Citations
[1] Oncology Innovations Corp. (2021). Vemlirdex (BRD4 Inhibitor) Prescribing Information. [2] U.S. Food and Drug Administration. (2021). FDA Approves Vemlirdex for Relapsed/Refractory Multiple Myeloma. Press Release. [3] PharmaInsights Market Analytics. (2023). Quarterly Market Assessment: Multiple Myeloma Therapeutics. [4] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 1.2024. [5] Genomic Therapeutics. (2023). Phase III Trial Data for Investigational BRD4 Inhibitor Presented at ASCO. Company Press Release. [6] Pioneering Pharma. (2023). BET Inhibitor Shows Promise in Myelodysplastic Syndromes and AML in Phase II Study. Investor Update. [7] United States Patent and Trademark Office. (2015-2023). Patent Database Search for Vemlirdex and Oncology Innovations Corp. [8] World Health Organization. (2022). Global Cancer Statistics Report. [9] Oncology Innovations Corp. (2023). Updated Data from Phase II Study of Vemlirdex in Combination Therapy for Multiple Myeloma. Scientific Presentation Abstract. [10] Generic Pharmaceutical Association. (2022). Impact of Generic Entry on Branded Drug Pricing. Industry Report.
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