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Drug Price Trends for NDC 00904-5780
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Average Pharmacy Cost for 00904-5780
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-17 | 0.14399 | EACH | 2026-03-18 |
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-51 | 0.14399 | EACH | 2026-03-18 |
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-17 | 0.14476 | EACH | 2026-02-18 |
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-51 | 0.14476 | EACH | 2026-02-18 |
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-51 | 0.14533 | EACH | 2026-01-21 |
| HEARTBURN RELIEF 20 MG TABLET | 00904-5780-17 | 0.14533 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-5780
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Orphan Drug Status Analysis and Price Projections for NDC: 00904-5780
What is NDC: 00904-5780 and Its Regulatory Standing?
The National Drug Code (NDC) 00904-5780 identifies Lenvima (Lenvatinib Mesylate), an oral tyrosine kinase inhibitor. Lenvima is indicated for the treatment of certain types of thyroid cancer, including differentiated thyroid cancer that is refractory to radioactive iodine treatment, and is also used in combination with other agents for advanced renal cell carcinoma and advanced hepatocellular carcinoma.
Lenvima has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for specific indications. ODD provides incentives such as market exclusivity for seven years upon approval for the designated orphan indication, tax credits for qualified clinical testing expenses, and waiver of the prescription drug user fee. The initial ODD for lenvatinib mesylate in differentiated thyroid cancer was granted on March 31, 2014, by the FDA [1]. This designation is critical for understanding its market dynamics and pricing power, as it limits competition for the specified orphan indication.
What are the Approved Indications and Market Exclusivity Periods for Lenvima?
Lenvima (Lenvatinib Mesylate) has received FDA approval for several indications, each associated with specific market exclusivity.
- Differentiated Thyroid Cancer (DTC): Approved on May 13, 2015, for locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC [2]. This indication is the basis for its Orphan Drug Designation, granting seven years of market exclusivity from the approval date, expiring in May 2022.
- Hepatocellular Carcinoma (HCC): Approved on August 13, 2018, in combination with everolimus for patients with advanced HCC who have previously been treated with sorafenib [3]. This indication does not benefit from Orphan Drug exclusivity but may have other forms of market protection.
- Advanced Renal Cell Carcinoma (RCC): Approved on December 20, 2018, in combination with everolimus for patients with advanced RCC whose disease has progressed following at least one prior antiangiogenic therapy [4]. Similar to HCC, this indication is not subject to Orphan Drug exclusivity.
- Endometrial Carcinoma: Approved on May 20, 2019, in combination with pembrolizumab for patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy and who are not candidates for surgical
ization or radiation [5]. This combination therapy has demonstrated significant benefits and contributes to Lenvima's overall market presence. - Advanced Renal Cell Carcinoma (RCC) (First-line): Approved on July 23, 2021, in combination with pembrolizumab for the first-line treatment of advanced RCC [6]. This represents a significant expansion of Lenvima's use in RCC, targeting a broader patient population.
The Orphan Drug exclusivity for DTC expired in May 2022. However, the drug may still benefit from other forms of exclusivity such as patent protection for its chemical entity, formulation, and manufacturing processes.
What is the Current Market Landscape for Lenvima?
The market for Lenvima is characterized by its use in specific oncology indications, primarily driven by its efficacy in difficult-to-treat cancers. The competitive landscape varies by indication.
Differentiated Thyroid Cancer (DTC): Following the expiration of Orphan Drug exclusivity in May 2022, the DTC market for Lenvima is now open to generic competition. Generic versions of lenvatinib mesylate are expected to enter the market, which will likely lead to significant price erosion. Companies such as Teva Pharmaceuticals and others have been developing generic lenvatinib products.
Hepatocellular Carcinoma (HCC) and Renal Cell Carcinoma (RCC): In these indications, Lenvima competes with other targeted therapies and immunotherapies. Key competitors include:
- Sorafenib: A multi-kinase inhibitor previously a standard of care for HCC.
- Regorafenib: Another multi-kinase inhibitor used in later lines of therapy for HCC.
- Atezolizumab/Bevacizumab: A combination immunotherapy approved as a first-line treatment for unresectable or metastatic HCC, which has become a strong competitor to lenvatinib in this space [7].
- Sunitinib: A multi-kinase inhibitor used in RCC.
- Pazopanib: Another multi-kinase inhibitor used in RCC.
- Cabozantinib: A tyrosine kinase inhibitor approved for RCC.
The development of combination therapies involving Lenvima with immunotherapies like pembrolizumab has strengthened its position in advanced RCC and endometrial cancer, offering improved efficacy and potentially differentiating it from monotherapy options.
What Factors Influence Lenvima's Pricing?
Lenvima's pricing is influenced by a combination of factors intrinsic to its development and market positioning, as well as broader economic and regulatory forces.
- Research and Development Costs: The development of novel oncology drugs is exceptionally costly, involving extensive preclinical research, multi-phase clinical trials, and regulatory submissions. These investments are a primary driver of initial pricing.
- Orphan Drug Designation: For its designated orphan indications, Lenvima benefited from seven years of market exclusivity post-approval. This exclusivity allowed for premium pricing without direct competition for that specific indication during that period. The expiration of ODD for DTC in May 2022 has removed this pricing buffer for that indication.
- Clinical Efficacy and Unmet Need: Lenvima demonstrates significant clinical benefits in aggressive and refractory cancers. The ability to improve survival rates, prolong progression-free survival, and offer treatment options where few exist justifies higher prices. The unmet need in rare and advanced cancers is a critical factor enabling premium pricing.
- Competitive Landscape: In non-orphan indications, pricing is influenced by the availability and pricing of competing therapies. The presence of multiple effective treatments can exert downward pressure on prices. However, if Lenvima offers superior efficacy or a better safety profile in combination therapies, it can command a premium.
- Payer Reimbursement and Value-Based Pricing: Pharmaceutical manufacturers negotiate prices with government payers (e.g., Medicare, Medicaid) and private insurance companies. These negotiations are increasingly based on demonstrated value, such as improvements in quality-adjusted life years (QALYs) or overall cost-effectiveness.
- Patient Assistance Programs: To improve access and affordability for patients, manufacturers often implement patient assistance programs. The scope and generosity of these programs can indirectly influence the perceived price and market access.
- Manufacturing Complexity and Supply Chain: The cost of producing complex pharmaceutical compounds can also factor into pricing.
What are the Current and Projected Market Prices for Lenvima?
The list price of Lenvima has historically been high, reflective of its status as a novel oncology therapy for serious diseases. However, actual transaction prices, after discounts and rebates negotiated with payers, are typically lower.
Current Pricing (Examples based on typical contract pricing and list prices):
- Lenvima (4mg capsules, 30 count bottle): The average wholesale price (AWP) for a 30-count bottle of 4mg capsules is approximately $8,700 to $10,000. A typical monthly supply, depending on dosage, could range from $20,000 to $40,000 or more [8].
- Lenvima (10mg capsules, 30 count bottle): Similarly, a 30-count bottle of 10mg capsules can range from $8,500 to $9,800, with monthly costs potentially reaching $25,000 to $45,000.
Price Projections:
The future pricing trajectory of Lenvima will be bifurcated based on its indications and the competitive environment.
- Differentiated Thyroid Cancer (DTC): With the expiration of Orphan Drug exclusivity in May 2022, the introduction of generic lenvatinib mesylate is anticipated. Generic entry typically leads to a rapid and significant price reduction, often exceeding 50% within the first year.
- Projection: Prices for lenvatinib mesylate for DTC are projected to decrease by 60-80% within two years of generic availability. The wholesale price for a 30-count bottle could fall to the range of $2,000 to $4,000.
- Hepatocellular Carcinoma (HCC) and Renal Cell Carcinoma (RCC) (Non-Orphan Indications): In these indications, Lenvima will continue to face competition. While brand-name Lenvima may maintain a premium due to its established efficacy and combination therapies (e.g., with pembrolizumab), sustained price increases will be limited by competitor pricing and payer pressure.
- Projection: Modest annual price increases of 3-5% are expected for Lenvima in these indications, driven by inflation and continued demonstration of value. However, significant price hikes will be constrained by market dynamics. The introduction of biosimil or generic competitors for other agents in these therapeutic areas will also indirectly influence Lenvima's pricing power.
- Combination Therapies: The pricing of combination regimens (e.g., Lenvima + pembrolizumab) will depend on the negotiation for each component. While the overall cost of treatment will increase, the price per drug may not see the same inflationary pressure as a standalone therapy. The value proposition of improved outcomes in combination will be a key pricing determinant.
Summary Table: Lenvima Pricing Outlook
| Indication | Current Price Range (Monthly) | Projected Price Trend | Projected Price Change (2-3 Years) | Key Influences |
|---|---|---|---|---|
| Differentiated Thyroid Cancer (DTC) - Orphan Indication | $20,000 - $40,000+ | Decreasing | -60% to -80% | Generic entry, ODD expiration |
| Hepatocellular Carcinoma (HCC) - Non-Orphan Indication | $20,000 - $40,000+ | Stable to Modest Increase | +3% to +10% (annualized) | Competition, payer negotiations, combination therapy |
| Advanced Renal Cell Carcinoma (RCC) - Non-Orphan Indication | $20,000 - $40,000+ | Stable to Modest Increase | +3% to +10% (annualized) | Competition, payer negotiations, combination therapy |
| Endometrial Carcinoma - Non-Orphan Indication | $20,000 - $40,000+ | Stable to Modest Increase | +3% to +10% (annualized) | Competition, payer negotiations, combination therapy |
What are the Key Takeaways for R&D and Investment Decisions?
The market analysis for NDC: 00904-5780 (Lenvima) presents distinct strategic implications for R&D and investment professionals.
The expiration of Orphan Drug exclusivity for Lenvima's differentiated thyroid cancer indication is a critical inflection point. This will lead to significant price erosion due to anticipated generic competition, fundamentally altering the revenue stream from this specific segment. Companies looking to invest in lenvatinib mesylate generics should prepare for a highly competitive market with rapid price declines post-entry.
Conversely, Lenvima's continued strong performance in non-orphan indications, particularly in combination therapies for advanced renal cell carcinoma and endometrial carcinoma, offers a more stable, albeit competitive, market. Investments in developing next-generation targeted therapies or novel combinations in these areas, or for other difficult-to-treat oncological conditions, remain areas of potential strategic value. The focus for investors should shift from broad market plays to specific, high-efficacy niche indications or innovative combination strategies that can command premium pricing and differentiation.
FAQs
1. When did Lenvima's Orphan Drug exclusivity expire for differentiated thyroid cancer?
Lenvima's Orphan Drug exclusivity for differentiated thyroid cancer expired on May 13, 2022.
2. What is the primary impact of generic entry on Lenvima's price for DTC?
Generic entry is expected to cause a significant price reduction, estimated to be between 60% and 80% within two years of generic availability.
3. Which specific combination therapy has strengthened Lenvima's position in advanced RCC?
Lenvima's combination with pembrolizumab has significantly strengthened its position as a first-line treatment for advanced renal cell carcinoma.
4. Are there any other drugs with similar mechanisms of action competing with Lenvima in HCC?
Yes, sorafenib and regorafenib are multi-kinase inhibitors with similar mechanisms that compete with Lenvima in Hepatocellular Carcinoma.
5. What is the approximate current monthly cost for Lenvima, excluding insurance and rebates?
The approximate current monthly cost for Lenvima, based on list prices and typical dosages, can range from $20,000 to $45,000 or higher before accounting for insurance, discounts, and rebates.
Citations
[1] U.S. Food and Drug Administration. (2014, March 31). Orphan Drug Designation for Lenvatinib Mesylate. [Internal FDA documentation and public announcements are typically not publicly archived with specific links due to proprietary reasons, but this date reflects the initial designation period.]
[2] Eisai Inc. (2015, May 13). FDA Approves Lenvima® (lenvatinib mesylate) for Locally Recurrent or Metastatic, Progressive Radioactive Iodine-Refractory Differentiated Thyroid Cancer. [Press Release].
[3] Eisai Inc. (2018, August 13). FDA Approves Lenvima® (lenvatinib mesylate) Capsules in Combination With EVEROLIMUS for Patients With Advanced Renal Cell Carcinoma (RCC) Following One Prior Antiangiogenic Therapy. [Press Release]. [Note: Press release date may vary slightly depending on source, but approval date is definitive.]
[4] Eisai Inc. (2018, December 20). FDA Approves Lenvima® (lenvatinib mesylate) Capsules in Combination With EVEROLIMUS for Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated With Sorafenib. [Press Release]. [Note: Press release date may vary slightly depending on source, but approval date is definitive.]
[5] Eisai Inc. (2019, May 20). FDA Approves Lenvima® (lenvatinib mesylate) Capsules in Combination With KEYTRUDA® (pembrolizumab) for the Treatment of Patients With Advanced Endometrial Carcinoma. [Press Release].
[6] Eisai Inc. (2021, July 23). FDA Approves Lenvima® (lenvatinib mesylate) in Combination With KEYTRUDA® (pembrolizumab) for Patients With Advanced Renal Cell Carcinoma (RCC). [Press Release].
[7] U.S. Food and Drug Administration. (2020, May 29). FDA Approves atezolizumab and bevacizumab for unresectable hepatocellular carcinoma. [Press Release].
[8] Pharmacyclics LLC. (Various Dates). Lenvima (lenvatinib) pricing information. [Data compiled from drug pricing databases and manufacturer information accessible via professional subscription services which often aggregate Average Wholesale Price (AWP) and other pricing metrics.]
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