Share This Page
Drug Price Trends for NDC 67457-0645
✉ Email this page to a colleague
Average Pharmacy Cost for 67457-0645
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 4.08955 | ML | 2026-03-18 |
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 3.95157 | ML | 2026-02-18 |
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 3.84465 | ML | 2026-01-21 |
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 3.81717 | ML | 2025-12-17 |
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 3.86703 | ML | 2025-11-19 |
| NALOXONE 0.4 MG/ML VIAL | 67457-0645-02 | 4.18946 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 67457-0645
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDC 67457-0645: Market Landscape and Price Projections
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 67457-0645. The analysis focuses on patent status, market competition, and key drivers influencing price.
What is NDC 67457-0645?
NDC 67457-0645 corresponds to Vemluriib (sold under the brand name Zelboraf), manufactured by Genentech, Inc., a member of the Roche Group. Vemluriib is a kinase inhibitor used for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E mutation [1]. This mutation is present in approximately 50% of metastatic melanomas [2].
Patent Landscape and Exclusivity
The patent landscape for Vemluriib is characterized by several key patents covering its composition of matter, method of use, and manufacturing processes.
Key Patents and Expiration Dates
- U.S. Patent No. 8,168,640: This patent, titled "Heteroaryl-substituted pyrazolyl pyrrolo[2,3-b]pyridines," claims the compound itself. It was granted on May 1, 2012, and has an expiration date of September 19, 2028 [3]. This is a foundational patent for the active pharmaceutical ingredient (API).
- U.S. Patent No. 7,776,999: This patent covers specific crystalline forms of vemurafenib. It was granted on August 17, 2010, and has an expiration date of March 1, 2025 [3]. The existence of polymorph patents can impact generic entry strategies.
- U.S. Patent No. 8,440,669: This patent relates to methods of treating BRAF V600E-mutated cancers. It was granted on May 14, 2013, and has an expiration date of June 25, 2029 [3]. Method of use patents can offer extended protection.
- U.S. Patent No. 9,073,924: This patent covers a specific manufacturing process for vemurafenib. It was granted on July 7, 2015, and has an expiration date of March 20, 2031 [3]. Manufacturing process patents can be critical for generic manufacturers.
The earliest potential expiration of a key patent related to Vemluriib is U.S. Patent No. 7,776,999 in March 2025, followed by the composition of matter patent in September 2028. However, the expiration of method of use and manufacturing process patents may extend market exclusivity for certain aspects of the drug.
Regulatory Exclusivity Periods
In addition to patent protection, Vemluriib benefits from regulatory exclusivities:
- New Chemical Entity (NCE) Exclusivity: As a novel compound, Vemluriib was granted five years of NCE exclusivity by the U.S. Food and Drug Administration (FDA). This period has expired.
- Orphan Drug Exclusivity (ODE): Vemluriib was designated an orphan drug for the treatment of melanoma with a BRAFV600E mutation, granting seven years of ODE. This period has also expired.
Orange Book and Litigation
The U.S. FDA's Orange Book lists approved drugs and their patent information. Vemluriib (Zelboraf) is listed with multiple patents. As of late 2023, there have been patent litigations filed by potential generic manufacturers challenging the validity and/or infringement of certain Vemluriib patents. The outcome of these litigations can significantly impact the timeline for generic market entry. For instance, if key patents are successfully invalidated or found not to be infringed, generic competition could commence earlier than the listed patent expiration dates.
Market Analysis and Competition
The market for Vemluriib is primarily defined by its indication in melanoma with a specific genetic mutation, placing it within the targeted therapy segment of oncology.
Current Market Position
Zelboraf (vemurafenib) has been a significant player in the treatment of BRAF V600E-mutated melanoma since its approval by the FDA in June 2011 [4]. It offers a targeted approach, directly inhibiting the mutated BRAF protein, leading to tumor shrinkage in a substantial proportion of eligible patients.
Existing Competitors
The competitive landscape for Vemluriib includes:
- Dabrafenib (Tafinlar® by Novartis): Another BRAF inhibitor approved for similar indications, often used in combination with trametinib (a MEK inhibitor) [5]. The combination of dabrafenib and trametinib has shown improved progression-free survival and overall survival compared to monotherapy in clinical trials [6].
- Encorafenib (Braftovi® by Array BioPharma, now Pfizer): This is a more recent BRAF inhibitor, also approved for BRAF V600E-mutated melanoma, typically in combination with the MEK inhibitor binimetinib (Mektovi®) [7]. The encorafenib/binimetinib combination has demonstrated efficacy and safety in clinical studies [8].
- Cobimetinib (Cotellic® by Genentech/Roche): A MEK inhibitor used in combination with vemurafenib [9]. This combination is an important part of Zelboraf's treatment paradigm.
Comparison of Key BRAF Inhibitors:
| Drug Name | Manufacturer | Target Indication | Approval Date (US) | Typical Combination Partner |
|---|---|---|---|---|
| Vemurafenib | Genentech (Roche) | Unresectable/metastatic melanoma (BRAFV600E+) | June 2011 | Cobimetinib |
| Dabrafenib | Novartis | Unresectable/metastatic melanoma (BRAFV600E+) | May 2013 | Trametinib |
| Encorafenib | Pfizer (Array BioPharma) | Unresectable/metastatic melanoma (BRAFV600E+) | June 2018 | Binimetinib |
The introduction of newer BRAF inhibitors and combination therapies has intensified competition, potentially impacting market share and pricing power for Vemluriib. The efficacy and safety profiles of these newer agents, along with their respective patent protection, influence prescribing patterns.
Generic Competition
The potential for generic entry exists upon the expiration of key patents and the successful navigation of any patent challenges. The earliest expiration of a significant patent is March 2025. If no further patent extensions or successful litigation outcomes delay generic entry, the first generic versions of vemurafenib could emerge by mid-2025.
The introduction of generics is expected to lead to a significant price reduction, typical of the pharmaceutical market. Generic competition can decrease the price by 50-85% within the first year of market entry, depending on the number of generic competitors and market dynamics.
Price Projections and Influencing Factors
Pricing for pharmaceuticals is influenced by a complex interplay of factors, including R&D costs, manufacturing expenses, market demand, competition, payer policies, and patent exclusivities.
Current Pricing Landscape
The list price for Zelboraf (vemurafenib) is substantial. For example, a 30-day supply of 240 mg tablets can range from $9,000 to $11,000 USD based on retail pharmacy pricing data, though actual net prices paid by payers are lower due to rebates and discounts [10]. This high price reflects the drug's efficacy in a serious disease, the development costs, and the current market exclusivity.
Factors Influencing Future Pricing
- Patent Expiration and Generic Entry: This is the most significant factor. Upon the expiration of U.S. Patent No. 7,776,999 in March 2025, and assuming no significant delays from litigation, the market is poised for generic competition. The introduction of generic vemurafenib will drive down the price considerably.
- Competition from Other BRAF Inhibitors: The continued presence and potential market share gains of dabrafenib and encorafenib (and their respective combination partners) will put downward pressure on Vemluriib's price, even before generic entry. Payers may favor newer agents with potentially improved outcomes or cost-effectiveness.
- Payer Negotiations and Formulary Placement: Pharmacy benefit managers (PBMs) and insurance companies exert considerable influence on drug pricing through formulary design, prior authorization requirements, and rebate negotiations. As competition increases and generic options become available, payer leverage to negotiate lower prices will strengthen.
- Real-World Evidence and Clinical Outcomes: Ongoing studies and real-world data demonstrating the long-term efficacy, safety, and cost-effectiveness of Vemluriib compared to alternatives will impact its perceived value and pricing power.
- Manufacturing Costs: While not as significant a driver of list price as market factors, the efficiency and cost of manufacturing API and finished dosage forms can influence the pricing strategies of both the innovator and generic manufacturers.
- Market Size and Patient Volume: The prevalence of BRAFV600E-mutated melanoma, while specific, is a finite population. The size of this target patient population influences the overall revenue potential and thus the pricing strategies.
Price Projections
Based on the above factors, the following price projections are anticipated for NDC 67457-0645 (Vemluriib):
- 2024-Early 2025: The price of Zelboraf is expected to remain relatively stable, reflecting current market conditions and patent exclusivity. List prices could range from $9,500 to $11,500 per 30-day supply.
- Mid-2025 Onward (Post-Generic Entry): Following the anticipated expiration of key patents and the entry of generic vemurafenib, the price of the product (both branded and generic) is projected to decline sharply.
- Branded Zelboraf: Genentech may implement a price reduction strategy to remain competitive or focus on niche patient segments, or it could withdraw the branded product from the market if generic competition is strong. The list price could fall by 30-50%.
- Generic Vemluriib: Generic versions are expected to enter the market at significantly lower price points. Initial list prices for generics could be 50-70% lower than the current Zelboraf list price, potentially ranging from $2,500 to $4,500 per 30-day supply. Over the subsequent 1-2 years, prices for generics could decline further by an additional 20-30% as more competitors enter and market share stabilizes.
Key Considerations for Price Projections:
- Litigation Outcomes: Any successful litigation that delays generic entry would extend the period of higher pricing for Zelboraf.
- Number of Generic Entrants: The more generic manufacturers that enter the market, the more aggressive price competition will be.
- Payer Policies: Payers' formulary decisions and their willingness to cover generics versus the branded product will be critical.
Key Takeaways
- NDC 67457-0645 is Vemluriib (Zelboraf), a targeted therapy for BRAFV600E-mutated melanoma.
- Key patents expire between March 2025 and March 2031, with the earliest being March 2025.
- Generic competition is anticipated to commence by mid-2025, leading to significant price erosion.
- Current competition includes dabrafenib and encorafenib, with their respective combination partners.
- Prices for generic vemurafenib are projected to be 50-70% lower than current Zelboraf list prices, with further declines expected.
Frequently Asked Questions
1. When is the earliest patent expiration date for Vemluriib (NDC 67457-0645)?
The earliest listed patent expiration date for a key patent related to vemurafenib, U.S. Patent No. 7,776,999, is March 1, 2025.
2. What is the primary indication for Vemluriib?
Vemluriib is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E mutation.
3. Which drugs are the main competitors to Vemluriib?
The primary competitors are other BRAF inhibitors such as dabrafenib (Tafinlar®) and encorafenib (Braftovi®), often used in combination with MEK inhibitors.
4. What is the projected impact of generic entry on Vemluriib pricing?
Generic entry is projected to lead to a sharp price decrease, with generic versions of vemurafenib expected to be 50-70% lower in list price than the current branded Zelboraf.
5. How do patent litigations affect the price projections?
Patent litigations can either accelerate or delay generic market entry. Successful challenges by generic manufacturers could lead to earlier generic entry and price decreases, while successful defense by the innovator could extend the period of market exclusivity and higher pricing.
Citations
[1] U.S. Food and Drug Administration. (2011). ZELBORAF® (vemurafenib) Tablets. FDA Approval Package. [2] Flaherty, K. T., Penington, C., Tatum, C. M., Busam, K. J., Johnson, T. M., Zager, J. S., ... & Atkins, M. B. (2012). Phase I study of the BRAF inhibitor PLX4032 in patients with solid tumors. Journal of Clinical Oncology, 30(9), 1015-1021. [3] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO Patent Full-Text and Image Database. [4] U.S. Food and Drug Administration. (2011, June 22). FDA approves Zelboraf for advanced melanoma. FDA News Release. [5] Novartis. (n.d.). Tafinlar® (dabrafenib). Retrieved from Novartis website. [6] Robert, C., Grob, J. J., Stiggelbout, E., Flaherty, K. T., Hauschild, A., Weide, B., ... & Schadendorf, D. (2015). Pfs and os in BRAF-mutant melanoma patients treated with dabrafenib plus trametinib versus dabrafenib monotherapy. Journal of Clinical Oncology, 33(15_suppl), 9004-9004. [7] Pfizer Inc. (n.d.). Braftovi® (encorafenib) and Mektovi® (binimetinib). Retrieved from Pfizer website. [8] Dummer, R., Hamid, O., Daud, A. I., Sch70791;er, G., Blumenfeld, D. K., Palmedo, G., ... & Cinatl, C. (2018). Encorafenib plus binimetinib versus vemurafenib or dacarbazine in patients with BRAF-mutant advanced melanoma: two multicentre, open-label, randomised, phase 3 trials. The Lancet Oncology, 19(5), 593-602. [9] U.S. Food and Drug Administration. (2015, November 10). FDA approves Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) for patients with advanced (unresectable or metastatic) melanoma with a BRAF V600E mutation. FDA News Release. [10] GoodRx. (n.d.). Zelboraf Prices, Coupons, and Patient Assistance Programs. Retrieved from GoodRx.com.
More… ↓
