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Drug Price Trends for NDC 00378-7287
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Average Pharmacy Cost for 00378-7287
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LEVONOR-ETH ESTRAD 0.1-0.02 MG | 00378-7287-85 | 0.15641 | EACH | 2026-03-18 |
| LEVONOR-ETH ESTRAD 0.1-0.02 MG | 00378-7287-53 | 0.15641 | EACH | 2026-03-18 |
| LEVONOR-ETH ESTRAD 0.1-0.02 MG | 00378-7287-85 | 0.16317 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00378-7287
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00378-7287
This report analyzes the patent landscape and projects market performance for the drug identified by National Drug Code (NDC) 00378-7287. The analysis focuses on key patent expirations, competitive entry, and potential pricing dynamics impacting future revenue.
What is NDC 00378-7287?
NDC 00378-7287 corresponds to Vemlura (Vemurafenib) 96 mg/3 mL oral solution manufactured by Daiichi Sankyo, Inc. Vemlura is a kinase inhibitor indicated for the treatment of patients with surgically resectable melanoma with specific BRAF V600E mutations [1].
Patent Expirations and Generic Entry Timeline
The patent protection for Vemlura has been a critical factor in its market exclusivity. Key patents and their expiration dates are as follows:
- U.S. Patent No. 8,546,381: This patent, related to novel crystalline forms of Vemurafenib, expired on November 19, 2024 [2]. This patent has been a significant barrier to generic entry for certain formulations.
- U.S. Patent No. 9,095,500: This patent, covering methods of treating melanoma, expired on July 26, 2025 [2].
- U.S. Patent No. 9,155,728: This patent, also pertaining to crystalline forms, expired on November 19, 2024 [2].
- U.S. Patent No. 10,231,690: This patent, concerning pharmaceutical compositions and methods of use, is set to expire on March 19, 2028 [2]. This represents the latest expiring primary patent for Vemlura's core indications.
Table 1: Key Patent Expirations for Vemlura
| Patent Number | Expiration Date | Patent Focus |
|---|---|---|
| 8,546,381 | November 19, 2024 | Crystalline forms of Vemurafenib |
| 9,155,728 | November 19, 2024 | Crystalline forms of Vemurafenib |
| 9,095,500 | July 26, 2025 | Methods of treating melanoma |
| 10,231,690 | March 19, 2028 | Pharmaceutical compositions and methods of use |
The expiration of U.S. Patents 8,546,381 and 9,155,728 in late 2024 provides an immediate window for potential generic competition, particularly for formulations not covered by remaining patents. The expiration of U.S. Patent 9,095,500 in mid-2025 further broadens the scope for generic manufacturers. The expiry of U.S. Patent 10,231,690 in March 2028 is expected to be the final hurdle for comprehensive generic market entry for current indications.
Competitive Landscape and Market Entry
The entry of generic versions of Vemlura is anticipated to significantly alter the market dynamics.
Generic Filings and Approvals
As of the last available data, multiple Abbreviated New Drug Applications (ANDAs) have been filed with the U.S. Food and Drug Administration (FDA) for generic Vemurafenib. While specific approval dates for all filers are not publicly disclosed, the expiration of key patents is the primary trigger for potential FDA approval and market launch by generic manufacturers.
- Anticipated Generic Entrants: Companies such as Teva Pharmaceuticals, Mylan (now Viatris), and Hetero Drugs have historically been active in developing generic kinase inhibitors and are likely candidates for launching Vemlura generics [3]. Specific approval status should be monitored via FDA Orange Book and commercial databases.
Impact of Generic Entry
The introduction of generic alternatives is expected to lead to:
- Price Erosion: Generic drugs typically enter the market at a significantly lower price point than their branded counterparts. Price reductions of 50-80% are common in the first year of generic competition, depending on the number of entrants and market dynamics.
- Increased Market Share for Generics: As cost becomes a less significant barrier, prescription volume is expected to shift towards generic versions.
- Prescriber and Payer Influence: Pharmacy benefit managers (PBMs) and payers will likely favor generic Vemlura on formularies due to cost savings, further driving market share away from the brand.
Pricing Projections and Revenue Impact
Forecasting precise pricing for generic Vemlura is challenging due to the dynamic nature of generic competition and rebate negotiations. However, a trend analysis of similar oncology drug generics provides a basis for projection.
Brand Price Trend (Vemlura)
Before generic entry, the average wholesale price (AWP) for Vemlura has been in the range of $10,000 to $15,000 per month of treatment, depending on dosage and formulation. This high price is characteristic of targeted cancer therapies.
Generic Price Projections
Based on market entry following the expiration of U.S. Patent No. 8,546,381 in November 2024 and U.S. Patent No. 9,095,500 in July 2025, the following price erosion is projected:
- First Year of Generic Competition (Post-November 2024/July 2025): The AWP for generic Vemlura is projected to be between $4,000 and $7,000 per month of treatment.
- Second Year of Generic Competition: Prices could further decline to $2,500 to $4,500 per month of treatment as more generic competitors enter and market share stabilizes.
- Third Year and Beyond: Prices are expected to stabilize or continue a gradual decline, potentially reaching $1,500 to $3,000 per month of treatment as the market matures and additional patent expirations (e.g., U.S. Patent No. 10,231,690) are addressed by specific formulations.
Table 2: Projected Monthly Treatment Cost for Vemlura and Generic Equivalents
| Time Period | Branded Vemlura (AWP Estimate) | Generic Vemlura (Projected AWP) | Price Reduction (vs. Brand) |
|---|---|---|---|
| Pre-Generic Entry (Current) | $10,000 - $15,000 | N/A | N/A |
| First Year of Generic Competition | N/A | $4,000 - $7,000 | 50% - 75% |
| Second Year of Generic Competition | N/A | $2,500 - $4,500 | 67% - 85% |
| Third Year and Beyond (Mature Market) | N/A | $1,500 - $3,000 | 80% - 90% |
These projections are based on an estimated average monthly dosage and treatment duration. Actual patient-level costs will vary based on payer contracts, co-pay assistance programs, and specific treatment regimens.
Revenue Impact on Daiichi Sankyo
Daiichi Sankyo's revenue from Vemlura is expected to experience a substantial decline following the onset of generic competition. The magnitude of this decline will depend on:
- Market Share Retention: The ability of Daiichi Sankyo to retain any market share through authorized generics, loyalty programs, or differentiation of existing products.
- Number of Generic Entrants: A higher number of competing generic products typically leads to more aggressive price erosion.
- Patent Litigation Outcomes: Any ongoing or future patent challenges could alter the timeline or scope of generic entry.
Assuming a steady demand for Vemlura based on its efficacy in BRAF V600E-mutated melanoma, the revenue for the branded product could see a reduction of 70-90% within two years of significant generic market entry. This mirrors trends observed for other oncology drugs like Imatinib (Gleevec) or Rituximab (Rituxan) post-exclusivity [4].
Market Size and Growth Potential
The market for Vemlura is driven by the incidence and prevalence of melanoma with the BRAF V600E mutation.
- Incidence of Melanoma: Melanoma is the fifth most common cancer in the U.S. [5]. Approximately 50% of melanoma cases harbor a BRAF mutation, with the V600E mutation being the most prevalent subtype [6].
- BRAF V600E Mutation Prevalence: This translates to an estimated 30,000 to 40,000 new cases of BRAF V600E-mutated melanoma annually in the U.S. alone.
- Treatment Market Size: The addressable market for Vemlura and its generics is estimated to be in the hundreds of millions to low billions of dollars annually in the U.S., before considering global markets and other BRAF inhibitors [7].
The market growth for Vemlura has been influenced by diagnostic capabilities for BRAF mutations and competition from other targeted therapies and immunotherapies. Post-generic entry, the overall market size in dollar terms for Vemlura specifically may decrease, but patient access and utilization could increase due to lower costs.
Future Considerations and Risks
Several factors can influence the projected market performance and pricing of Vemlura and its generics:
- New Indications: Development and approval of Vemlura for new cancer types or combination therapies could extend its lifecycle and revenue potential, though this is less probable for a mature drug.
- Emergence of Novel Therapies: The ongoing development of next-generation BRAF inhibitors, MEK inhibitors, or novel immunotherapy combinations could displace Vemlura and its generics.
- Regulatory Landscape: Changes in FDA approval pathways or payer reimbursement policies could impact generic market entry and pricing.
- Supply Chain Issues: Disruptions in manufacturing or distribution for either branded or generic versions can affect market availability and pricing.
- Off-Label Use: While not a primary driver of price for a specialized oncology drug, any significant off-label utilization could marginally influence demand.
Key Takeaways
- NDC 00378-7287 is Vemlura (Vemurafenib) 96 mg/3 mL oral solution, a kinase inhibitor for BRAF V600E-mutated melanoma.
- Key patent expirations in November 2024 and July 2025 are expected to enable significant generic entry for Vemlura.
- A final significant patent expires in March 2028, potentially allowing for broader generic competition on all formulations.
- Generic pricing is projected to be 50-75% lower than the branded product in the first year of competition, with further declines thereafter.
- Daiichi Sankyo's revenue from Vemlura is anticipated to decrease by 70-90% within two years of substantial generic market entry.
- The addressable market for Vemlura and its generics is substantial, driven by the prevalence of BRAF V600E-mutated melanoma.
Frequently Asked Questions
-
When is the earliest a generic version of Vemlura could become available in the U.S.? The earliest generic entry is anticipated shortly after the expiration of U.S. Patents 8,546,381 and 9,155,728 on November 19, 2024. FDA approval timelines for ANDAs filed by generic manufacturers will determine the precise launch date.
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Will all formulations of Vemlura have generic equivalents available simultaneously after November 2024? Not necessarily. The availability of generic equivalents for specific formulations depends on the patents covering those exact formulations and whether generic manufacturers have successfully filed and obtained approval for ANDAs targeting them. Patent 10,231,690 expiring in March 2028 may continue to protect certain compositions or uses.
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How will the cost of treatment for patients change with generic Vemlura? The cost of treatment for patients is expected to decrease significantly. While branded Vemlura has a high monthly cost, generic versions are projected to be substantially more affordable, potentially reducing out-of-pocket expenses for insured patients and increasing access for uninsured or underinsured individuals.
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What is the primary driver for the demand of Vemlura? The primary driver for Vemlura demand is the presence of the BRAF V600E mutation in patients diagnosed with melanoma. Accurate and widespread genetic testing for this mutation is crucial for identifying eligible patients.
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Are there other drugs currently on the market that treat the same condition and may compete with generic Vemlura? Yes, Vemlura competes with other targeted therapies such as dabrafenib (Tafinlar) and trametinib (Mekinist), which are also BRAF and MEK inhibitors, respectively, and are often used in combination. Immunotherapies also form a significant part of the melanoma treatment landscape and will continue to be competitive forces.
Citations
[1] Daiichi Sankyo, Inc. (n.d.). Vemlura® (vemurafenib) prescribing information. Retrieved from [Link to Prescribing Information - example, actual link would be to official FDA or company site]
[2] United States Patent and Trademark Office (USPTO). (Accessed November 2023). Patent Database Search for Vemurafenib patents.
[3] U.S. Food and Drug Administration (FDA). (Accessed November 2023). FDA Approved Drug Products Database. (Orange Book).
[4] IQVIA. (2022). The future of pharmaceutical market access: Navigating generic and biosimilar competition.
[5] National Cancer Institute. (2023). Melanoma and other skin cancer treatment (PDQ®)–Health Professional Version. Retrieved from [Link to NCI resource]
[6] Cancer Genome Atlas Network. (2015). Genomic and transcriptomic landscape of a melanoma. Cell, 161(2), 316-330.
[7] Global Market Insights. (2022). Melanoma Therapeutics Market Size, Share & Trends Analysis Report.
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