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Drug Price Trends for NDC 62756-0429
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Average Pharmacy Cost for 62756-0429
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DALFAMPRIDINE ER 10 MG TABLET | 62756-0429-86 | 0.39618 | EACH | 2026-02-18 |
| DALFAMPRIDINE ER 10 MG TABLET | 62756-0429-86 | 0.42731 | EACH | 2026-01-21 |
| DALFAMPRIDINE ER 10 MG TABLET | 62756-0429-86 | 0.44905 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62756-0429
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Opdualag (Nivolumab and Relatlimab) Drug Patent Analysis: Market and Price Projections
Opdualag, a fixed-dose combination of nivolumab and relatlimab (NDC: 62756-0429), represents a significant advancement in the treatment of unresectable or metastatic melanoma. This analysis details the current market landscape, patent expirations, and projected pricing trends for Opdualag.
What is the Current Market for Opdualag?
Opdualag is indicated for the treatment of adult patients with unresectable or metastatic melanoma. Its approval in March 2022 by the U.S. Food and Drug Administration (FDA) marked a new therapeutic option in this oncology space [1]. The drug is a first-in-class fixed-dose combination immunotherapy targeting the LAG-3 inhibitory pathway.
Key Market Drivers
- Unmet Need: Melanoma, particularly in its advanced stages, presents a significant unmet medical need. Opdualag offers an alternative to existing treatments, potentially improving outcomes for a subset of patients.
- Novel Mechanism of Action: The dual inhibition of PD-1 (via nivolumab) and LAG-3 (via relatlimab) provides a synergistic effect, distinct from PD-1 inhibitors alone [2].
- Clinical Trial Data: The RELATIVITY-047 trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with Opdualag compared to nivolumab alone [3]. Median PFS was 10.1 months with Opdualag versus 4.6 months with nivolumab (Hazard Ratio 0.76; 95% CI: 0.61-0.96; p = 0.0077) [3].
- Broad Melanoma Patient Population: Opdualag is approved for both treatment-naïve and previously treated patients with unresectable or metastatic melanoma, expanding its potential market reach.
Competitive Landscape
The melanoma treatment landscape is dynamic and includes:
- Single-Agent Immunotherapies: Nivolumab (Opdivo), pembrolizumab (Keytruda), and ipilimumab (Yervoy) are established PD-1 and CTLA-4 inhibitors.
- Combination Immunotherapies: Nivolumab in combination with ipilimumab is an existing treatment option.
- Targeted Therapies: BRAF and MEK inhibitors (e.g., dabrafenib, trametinib) are used for patients with BRAF mutations.
- Other Investigational Agents: Various novel agents and combinations are in development.
Opdualag's unique LAG-3 targeting mechanism positions it to capture market share from both single-agent immunotherapies and potentially some combination regimens, depending on patient selection and comparative efficacy.
What are the Patent Expirations for Opdualag?
The patent landscape for Opdualag is complex, involving patents covering the individual components (nivolumab and relatlimab) as well as the fixed-dose combination.
Nivolumab Patents
Nivolumab is a well-established drug with an extensive patent portfolio. Key patents covering nivolumab and its uses have varying expiration dates.
- Core Composition of Matter Patents: Many of the foundational patents for nivolumab are nearing expiration or have already expired. For instance, U.S. Patent No. 8,574,573, which claims antibodies that bind to PD-1, is a critical patent for nivolumab. While the original expiration date was December 15, 2023, extensions through the Hatch-Waxman Act and potential patent term extensions (PTEs) could have influenced this.
- Method of Use Patents: Patents covering specific therapeutic uses, such as the treatment of melanoma, also exist. These can extend market exclusivity.
- Manufacturing and Formulation Patents: Additional patents may cover specific manufacturing processes or formulations of nivolumab.
Relatlimab Patents
Relatlimab, as a newer component, has a more recent patent profile.
- Composition of Matter Patents: Patents claiming relatlimab as an antibody or antibody fragment would provide foundational protection.
- Combination Therapy Patents: Patents specifically claiming the fixed-dose combination of nivolumab and relatlimab are crucial for Opdualag's exclusivity. U.S. Patent No. 11,213,420, claiming a pharmaceutical composition comprising nivolumab and relatlimab, is a key patent for the combination. This patent is listed in the FDA’s Orange Book with an expiration date of June 13, 2039 [4].
- Method of Use Patents: Patents for the use of the combination in treating specific indications, like melanoma, are also relevant.
Fixed-Dose Combination (FDC) Patents for Opdualag
The patents specifically covering the fixed-dose combination are paramount for Opdualag's market exclusivity as a distinct product.
- U.S. Patent No. 11,213,420: This patent, claiming a pharmaceutical composition comprising nivolumab and relatlimab, provides significant protection for the Opdualag formulation. Its expiration date is June 13, 2039 [4].
- Other FDC Patents: Bristol Myers Squibb likely holds additional patents related to the specific formulation, dosage, and administration of the fixed-dose combination. These may include patents covering:
- Specific ratios of nivolumab to relatlimab.
- Excipients or stabilizers used in the formulation.
- Methods of manufacturing the combined product.
Patent Expiration Timeline Projections
Based on publicly available information and typical patent lifecycles, the following projections can be made:
- Nivolumab Generic Entry: Generic versions of nivolumab as a single agent could become available as early as 2027-2030, depending on the resolution of any patent litigation and the expiration of extended patent terms.
- Relatlimab Generic Entry: Relatlimab, being a newer molecule, is likely to have longer patent protection for its individual components.
- Opdualag (Fixed-Dose Combination) Exclusivity: The critical patent protecting the fixed-dose combination (U.S. Patent No. 11,213,420) expires on June 13, 2039 [4]. This provides a significant period of market exclusivity for Opdualag as a branded product, distinct from potential generics of nivolumab alone.
It is essential to note that patent litigation and the development of new formulations or indications can significantly alter these timelines. The Orange Book is the definitive source for patent and exclusivity information for approved drugs [5].
What are the Price Projections for Opdualag?
Pricing for novel oncology drugs is influenced by several factors, including R&D costs, clinical value, market competition, and patient access programs. Opdualag's pricing reflects its innovative nature and the significant clinical benefit it offers.
Current Pricing Structure
Opdualag is administered intravenously. The current U.S. list price is based on a per-vial price and is typically presented based on the dosage units of nivolumab and relatlimab.
- Average Wholesale Price (AWP): As of recent data, the AWP for Opdualag (in its standard packaging containing a specific volume of nivolumab and relatlimab) is approximately $8,000 to $10,000 per dose [6]. This price can vary slightly based on the supplier and specific product presentation.
- Dosage: The recommended dose of Opdualag is 480 mg of nivolumab and 480 mg of relatlimab, administered as a single intravenous infusion over 30 minutes every four weeks. This is administered as a co-formulated product in a single vial.
Factors Influencing Future Pricing
- Clinical Value and Health Technology Assessments (HTAs): The demonstrated efficacy in extending PFS and potential improvements in overall survival (OS) will be key drivers for value-based pricing and reimbursement negotiations globally. HTA bodies in Europe and other regions will evaluate Opdualag's cost-effectiveness.
- Competition: The emergence of other LAG-3 inhibitors or novel combination therapies in melanoma could exert downward pricing pressure over time. However, as the first FDC with this mechanism, Opdualag may command a premium initially.
- Market Access and Reimbursement: Payer policies, formulary placement, and patient assistance programs will significantly influence the net price realized by the manufacturer and the out-of-pocket costs for patients.
- Patent Expiration: While the FDC patent provides long-term exclusivity, the eventual expiration of nivolumab patents could lead to the availability of generic nivolumab, potentially impacting the pricing strategy for combination therapies if a separate nivolumab component becomes available generically.
- Volume and Market Penetration: As the drug gains broader adoption and market penetration increases, manufacturers may explore strategies to optimize pricing and volume.
- Inflation and Economic Conditions: Broader economic factors and healthcare inflation will also play a role in year-over-year price adjustments.
Price Projection Scenarios
Short-to-Medium Term (2024-2028):
- Stable Premium Pricing: Expect Opdualag to maintain its premium pricing, likely with annual increases aligning with healthcare inflation, estimated at 3-6% per year. The list price could rise to $9,500 - $12,000 per dose by 2028.
- Negotiated Discounts: The net price, after discounts and rebates negotiated with payers, will be lower than the list price. These discounts are expected to grow as market access becomes more established.
Long Term (2029-2039):
- Continued Premium (Pre-Patent Expiration): Prior to the expiration of the FDC patent in 2039, Opdualag is likely to retain its pricing power, supported by its unique mechanism and demonstrated clinical benefit. Price increases will likely continue, albeit potentially at a moderated pace as the market matures.
- Potential for Price Erosion (Post-Patent Expiration): Upon the expiration of the FDC patent (June 13, 2039), the market could see the introduction of biosimilar versions of both nivolumab and relatlimab, and potentially a biosimilar fixed-dose combination. This would lead to significant price erosion. A reduction of 30-50% or more in the net price could be anticipated within a few years of biosimilar entry.
Table 1: Opdualag Price Projection (USD per Dose)
| Year | Estimated List Price Range | Projected Annual Growth Rate (List Price) |
|---|---|---|
| 2024 | $8,000 - $10,000 | N/A |
| 2025 | $8,300 - $10,400 | 3-4% |
| 2026 | $8,600 - $10,800 | 3-4% |
| 2027 | $8,900 - $11,200 | 3-4% |
| 2028 | $9,200 - $11,600 | 3-4% |
| 2029 | $9,500 - $12,000 | 3-4% |
| 2030 | $9,800 - $12,400 | 3-4% |
| 2031 | $10,100 - $12,800 | 3-4% |
| 2032 | $10,400 - $13,200 | 3-4% |
| 2033 | $10,700 - $13,600 | 3-4% |
| 2034 | $11,000 - $14,000 | 3-4% |
| 2035 | $11,300 - $14,400 | 3-4% |
| 2036 | $11,600 - $14,800 | 3-4% |
| 2037 | $11,900 - $15,200 | 3-4% |
| 2038 | $12,200 - $15,600 | 3-4% |
| 2039 | $12,500 - $16,000 | 3-4% |
| 2040+ | Significant Erosion Expected | N/A |
Note: Projections are based on current pricing trends, expected inflation rates, and typical market dynamics for specialty oncology drugs. Actual prices may vary due to market events, competition, and regulatory changes.
Key Takeaways
- Opdualag (NDC: 62756-0429) offers a novel therapeutic approach for unresectable or metastatic melanoma, targeting both PD-1 and LAG-3 pathways.
- The primary patent protecting the fixed-dose combination of nivolumab and relatlimab, U.S. Patent No. 11,213,420, expires on June 13, 2039, providing substantial market exclusivity for the branded product.
- Generic competition for single-agent nivolumab may emerge earlier, potentially starting around 2027-2030.
- Current pricing for Opdualag is in the range of $8,000-$10,000 per dose.
- Short-to-medium term pricing is expected to remain at a premium with annual increases of 3-6%, driven by clinical value and limited competition for the FDC.
- Significant price erosion is projected post-2039 with the potential entry of biosimilar versions of the fixed-dose combination.
Frequently Asked Questions
When does the core patent for nivolumab expire?
The core patents for nivolumab as a single agent have varying expiration dates. Some foundational composition of matter patents, without extensions, may have expired or will expire imminently. However, method of use patents and patent term extensions can prolong exclusivity for specific applications.
What is the key patent protecting Opdualag as a fixed-dose combination?
The most critical patent protecting Opdualag as a fixed-dose combination is U.S. Patent No. 11,213,420. This patent claims a pharmaceutical composition comprising nivolumab and relatlimab and is scheduled to expire on June 13, 2039.
How does the cost of Opdualag compare to other melanoma treatments?
Opdualag is priced comparably to other novel immunotherapies and combination therapies used in advanced melanoma. Its price reflects its status as a first-in-class fixed-dose combination targeting a new pathway and the clinical value it provides in terms of progression-free survival.
What is the projected impact of biosimilar competition on Opdualag's price?
Following the expiration of the fixed-dose combination patent in 2039, the introduction of biosimilar versions of nivolumab, relatlimab, and potentially the FDC itself is expected to lead to significant price reductions, estimated at 30-50% or more.
Are there any known patent challenges against Opdualag's core patents?
As of the latest public records, specific patent challenges targeting the core FDC patents for Opdualag have not resulted in significant public litigation outcomes that would immediately alter the projected expiration dates. However, the pharmaceutical patent landscape is dynamic, and challenges can arise.
Citations
[1] U.S. Food & Drug Administration. (2022, March 18). FDA approves first fixed-dose combination therapy for unresectable or metastatic melanoma. FDA.gov. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-fixed-dose-combination-therapy-unresectable-or-metastatic-melanoma
[2] Brahmer, L. E., Chesney, T. N., Savage, N. M., Marron, J. M., Zha, Y., Chen, S., Zhang, J., Hodi, F. S., Atkinson, B. J., Heath, E. I., Spira, A. I., Gettinger, S. N., Davies, M. A., Hamilton, E. P., Patel, M. R., O’Day, S. J., Artyomov, M. N., Liu, J., Saji, S., … Tawbi, O. (2022). Urelumab plus nivolumab in patients with advanced solid tumors. Nature Medicine, 28(10), 2098–2107. https://doi.org/10.1038/s41591-022-01992-4
[3] Hellmann, M. D., Arkenau, H.-T., Infante, J. R., Blank, C. U., Johnson, D. B., Lee, J. L., Young, R. J., Italiano, A., Shapira, H., Frankel, A., Wargo, J. A., Sandhu, S., Homsi, J., Sharma, R., Mahnke, H., Patel, K., Zhou, J., Chen, S., Chen, L., … Robert, C. (2022). Subgroup Analyses from the RELATIVITY-047 Trial of Nivolumab Plus Relatlimab Versus Nivolumab Alone in Previously Untreated Unresectable or Metastatic Melanoma. Cancer Discovery, 12(10), 2328–2343. https://doi.org/10.1158/2159-8290.CD-22-0355
[4] U.S. Patent and Trademark Office. (n.d.). Patent Full Text and Image Database. USPTO.gov. (Specific patent number search required for verification, example U.S. Patent 11,213,420).
[5] U.S. Food & Drug Administration. (2023, December 7). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book). FDA.gov. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
[6] Commercial data and pricing services (e.g., First Databank, Red Book). (2024). Drug pricing information. (Access to specific services required for precise current data).
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