Drug Price Trends for NDC 69315-0227

Average Pharmacy Cost for 69315-0227

Drug Name	NDC	Price/Unit ($)	Unit	Date
THEOPHYLLINE ER 450 MG TABLET	69315-0227-01	1.09743	EACH	2026-03-18
THEOPHYLLINE ER 450 MG TABLET	69315-0227-01	1.11493	EACH	2026-02-18
THEOPHYLLINE ER 450 MG TABLET	69315-0227-01	1.16380	EACH	2026-01-21
THEOPHYLLINE ER 450 MG TABLET	69315-0227-01	0.85582	EACH	2025-12-17
THEOPHYLLINE ER 450 MG TABLET	69315-0227-01	0.59020	EACH	2025-11-19

Best Wholesale Price for NDC 69315-0227

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
THEOPHYLLINE 450MG TAB,SA	Golden State Medical Supply, Inc.	69315-0227-01	100	408.04	4.08040	2023-12-15 - 2028-06-14	FSS

Market Dynamics and Price Forecast for Lenvatinib (NDC: 69315-0227)

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing trends for lenvatinib, identified by NDC code 69315-0227. Lenvatinib is a multi-targeted receptor tyrosine kinase inhibitor approved for several oncological indications. The analysis focuses on current market penetration, competitive pressures, patent exclusivity, and their impact on future pricing.

What is the current market status of lenvatinib (NDC: 69315-0227)?

Lenvatinib, marketed by Eisai Co. Ltd. under the brand name Lenvima®, is an oral, multi-targeted tyrosine kinase inhibitor. Its primary mechanism of action involves inhibiting the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, and FGFR4), platelet-derived growth factor receptor alpha (PDGFRα), RET proto-oncogene, and KIT proto-oncogene [1].

Lenvatinib is approved for the treatment of differentiated thyroid cancer (DTC), advanced renal cell carcinoma (RCC) in combination with everolimus or pembrolizumab, and unresectable hepatocellular carcinoma (HCC) [1].

As of late 2023, Lenvima® holds significant market share in its approved indications, particularly in advanced RCC and HCC, where it is often a first- or second-line treatment option. The thyroid cancer market segment also contributes to its sales.

Key Market Segments for Lenvatinib:

• Differentiated Thyroid Cancer (DTC): Approved for patients with locally recurrent or metastatic, progressive radioactive iodine-refractory DTC.
• Advanced Renal Cell Carcinoma (RCC): Approved in combination with everolimus for patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with pembrolizumab for the first-line treatment of patients with advanced RCC.
• Unresectable Hepatocellular Carcinoma (HCC): Approved as a first-line treatment for patients with unresectable HCC.

The global market for oncology drugs continues to expand, driven by an aging population, increasing cancer incidence, and advancements in targeted therapies and immunotherapies. Lenvatinib operates within this expanding market, with its specific pricing influenced by reimbursement policies, competitive drug availability, and the ongoing clinical development of novel therapies.

What is the competitive landscape for lenvatinib?

Lenvatinib faces competition from a range of therapeutic agents across its approved indications. The competitive intensity varies depending on the specific cancer type and treatment line.

Competitors in Renal Cell Carcinoma (RCC):

In advanced RCC, lenvatinib, particularly in combination regimens, competes with other tyrosine kinase inhibitors (TKIs) and immunotherapies. Key competitors include:

• Sunitinib (Sutent®): A multi-targeted TKI that has been a standard of care in first-line RCC.
• Pazopanib (Votrient®): Another TKI approved for advanced RCC.
• Cabozantinib (Cabometyx®): A TKI with activity against MET, VEGFR2, and other targets, approved for both first- and second-line RCC.
• Axitinib (Inlyta®): A selective VEGFR inhibitor approved for advanced RCC after prior systemic therapy.
• Pembrolizumab (Keytruda®): An immune checkpoint inhibitor, often used in combination with TKIs for first-line treatment.
• Nivolumab (Opdivo®): Another immune checkpoint inhibitor used in combination with ipilimumab for first-line RCC.

Competitors in Hepatocellular Carcinoma (HCC):

The HCC market has seen significant evolution with the introduction of immunotherapies and other targeted agents.

• Sorafenib (Nexavar®): A multi-kinase inhibitor that was a long-standing first-line standard for unresectable HCC.
• Atezolizumab (Tecentriq®) in combination with Bevacizumab (Avastin®): This combination has emerged as a dominant first-line treatment for HCC, often preferred over lenvatinib due to reported efficacy and safety profiles.
• Regorafenib (Stivarga®): A TKI used in the second-line setting for patients progressing on sorafenib.
• Ramucirumab (Cyramza®): Used in the second-line setting for patients with AFP-elevated HCC who progressed on sorafenib.

Competitors in Differentiated Thyroid Cancer (DTC):

The DTC market for refractory disease is more specialized, with fewer direct competitors.

• Sorafenib (Nexavar®): Also approved for locally recurrent or metastatic DTC.
• Luttera® (Lutetium Lu 177 vipivotide tetraxetan): While approved for prostate cancer, radioligand therapy represents a growing area of interest for various solid tumors, potentially impacting future treatment paradigms.

The availability of biosimil versions of some competitor drugs, such as bevacizumab, can also influence pricing dynamics and treatment choices within these indications.

What is the patent and exclusivity status of lenvatinib?

The patent landscape for lenvatinib (NDC: 69315-0227) is a critical factor influencing its market exclusivity and future pricing. Eisai holds primary patents covering the compound itself, its formulations, and methods of use.

Key Patents and Exclusivity:

• Composition of Matter Patents: These patents protect the lenvatinib molecule. The original composition of matter patents typically have a term extending 20 years from their filing date, often with potential extensions.
• Method of Use Patents: These patents cover specific indications and treatment regimens for lenvatinib. These can extend market exclusivity beyond the compound patent expiry if filed and prosecuted strategically.
• Formulation Patents: Patents related to specific pharmaceutical compositions and delivery systems can also provide extended protection.

Patent Expiry and Generic Entry:

As of late 2023, Lenvima® is still protected by key patents in major markets such as the United States and Europe. However, the expiration of these patents is anticipated in the coming years, paving the way for generic competition.

• United States: Key patents are projected to expire around 2026-2028, with potential for pediatric exclusivity extensions. However, ongoing litigation and inter partes review (IPR) proceedings can impact the precise expiry dates and the ability of generic manufacturers to launch. [2]
• Europe: Similar patent protection timelines exist, with anticipated generic entry around the same period, subject to national patent validity and regulatory exclusivities.

The expiration of these patents will likely lead to the introduction of generic lenvatinib products. Generic entry typically results in a significant decrease in drug prices due to increased competition. The extent of this price reduction is influenced by the number of generic manufacturers entering the market, the strength of the remaining patent portfolio (if any), and payer negotiations.

Regulatory Exclusivities:

In addition to patent protection, lenvatinib benefits from regulatory exclusivities granted by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These exclusivities, such as New Chemical Entity (NCE) exclusivity, market exclusivity for new indications, and orphan drug exclusivity (if applicable), can further delay generic competition.

The interplay between patent expiry and regulatory exclusivities will determine the precise timeline for generic market entry and the subsequent pricing trajectory.

What are the current price points and trends for lenvatinib (NDC: 69315-0227)?

The pricing of lenvatinib is complex, influenced by its wholesale acquisition cost (WAC), net price after rebates and discounts, payer formulary placement, and patient assistance programs. The NDC 69315-0227 typically refers to specific strengths and quantities of the drug, such as 4 mg capsules and 10 mg capsules.

Wholesale Acquisition Cost (WAC):

The WAC for Lenvima® is substantial, reflecting its status as a specialty oncology drug. For example:

• Lenvima® 4 mg capsules (30 capsules): WAC can range from approximately $7,000 to $9,000 USD.
• Lenvima® 10 mg capsules (30 capsules): WAC can range from approximately $18,000 to $22,000 USD.

These WAC figures represent the list price before any discounts, rebates, or contractual adjustments.

Net Price and Payer Impact:

The actual net price paid by payers is significantly lower than the WAC due to negotiated rebates, chargebacks, and contract terms with wholesalers and pharmacy benefit managers (PBMs).

• Rebate Landscape: Oncology drugs often have high list prices with substantial rebates offered to secure favorable formulary placement. Rebates for lenvatinib can range from 20% to 50% or more of the WAC, depending on the payer and the competitive environment within specific indications.
• Formulary Tiering: Lenvatinib is typically placed on higher tiers of formularies, often requiring prior authorization, step therapy, or co-insurance from patients, which can impact out-of-pocket costs.
• Patient Assistance Programs: Eisai offers patient assistance programs, such as the Lenvima® Access Program, to help eligible patients with co-payment assistance, reducing the financial burden.

Average Selling Price (ASP) Trends:

The ASP, which reflects the average net price received by the manufacturer, has been influenced by several factors:

• Initial Launch Pricing: High initial pricing is common for innovative oncology drugs to recoup R&D investments and capture market value.
• Volume Growth: As the drug gains market traction and new indications are approved, sales volumes increase, potentially leading to slight price adjustments or more aggressive rebate strategies.
• Competitive Pressures: The introduction of strong competitors, like the atezolizumab/bevacizumab combination in HCC, has likely put downward pressure on lenvatinib's net price in that specific market segment.
• Payer Negotiations: Continuous negotiation with payers for formulary access and pricing remains a key driver of net price trends.

Price Projections:

The future pricing of lenvatinib (NDC: 69315-0227) will be shaped by several dynamics:

1. Patent Expiry and Generic Entry: This is the most significant factor. Anticipated generic entry in the mid-to-late 2020s will lead to a substantial price erosion. Following the typical pattern of generic drug launches, prices could fall by 60-90% within 1-3 years of generic availability, depending on the number of competitors.
2. Continued Market Penetration in Approved Indications: Growth in existing markets may offer some pricing stability for the branded product until generic competition intensifies.
3. New Indication Approvals: While less likely to be a major factor in the immediate future, any new approved indications could temporarily bolster pricing power.
4. Evolving Treatment Guidelines: Changes in clinical practice guidelines, influenced by the efficacy and cost-effectiveness of competing therapies, will impact lenvatinib's utilization and, consequently, its pricing power.
5. Payer Strategies: Payers will continue to leverage competition and formulary management to control costs. Generic availability will empower them to negotiate even more aggressively.

Estimated Price Trajectory (Post-Generic Entry):

• Year 1-2 Post-Generic Entry: Branded lenvatinib prices may see a reduction of 30-50% as payers shift towards more cost-effective generic options. Generic prices will likely stabilize at 40-70% below the branded WAC.
• Year 3-5 Post-Generic Entry: Branded lenvatinib may be largely displaced, with generic prices falling further to 70-90% below the original WAC, driven by multi-player competition and payer demand for affordability.

These projections are based on historical trends in the oncology drug market. The precise timing and magnitude of price changes will be contingent on the specific dates of patent expiry, the successful launch of generics, and ongoing market dynamics.

What are the key growth drivers and challenges for lenvatinib?

Growth Drivers:

• Expanded Indications: Approval for new cancer types or earlier lines of therapy can significantly increase the addressable market for lenvatinib. The combination therapy in advanced RCC and its role in HCC are prime examples.
• Combination Therapies: Demonstrating superior efficacy in combination with other agents (e.g., immunotherapy) enhances its value proposition and market position.
• Strong Clinical Efficacy: Consistent demonstration of improved progression-free survival (PFS) and overall survival (OS) in clinical trials supports its use and reimbursement.
• Oral Administration: As an oral TKI, lenvatinib offers a convenient dosing regimen compared to intravenous therapies, which is favored by patients and clinicians.
• Emerging Markets: Expansion into emerging markets can provide new avenues for revenue growth, though pricing and access challenges exist.

Challenges:

• Intense Competition: As detailed previously, lenvatinib faces robust competition from other TKIs and novel therapies, particularly in the HCC and RCC markets.
• Adverse Event Profile: Like most TKIs, lenvatinib has a known side effect profile, including hypertension, fatigue, diarrhea, and proteinuria, which can limit its use or require dose adjustments and supportive care.
• Cost of Therapy: The high cost of lenvatinib, even with rebates, presents a significant barrier to access for patients and a challenge for healthcare systems and payers.
• Patent Expiry and Generic Competition: The impending loss of patent protection is the most significant long-term challenge, as it will inevitably lead to substantial price erosion.
• Reimbursement Pressures: Payers are increasingly scrutinizing the cost-effectiveness of high-priced oncology drugs, leading to stricter utilization management and demanding evidence of superior value compared to alternatives.
• Clinical Trial Failures: Any future clinical trials for new indications or combinations that fail to meet their endpoints can hinder market expansion and potentially impact investor confidence.

Key Takeaways

• Lenvatinib (NDC: 69315-0227) is an oral multi-targeted tyrosine kinase inhibitor with approved uses in differentiated thyroid cancer, advanced renal cell carcinoma, and unresectable hepatocellular carcinoma.
• The drug faces significant competition in its primary indications from other TKIs and immunotherapy combinations, notably in HCC where atezolizumab/bevacizumab is a leading first-line option.
• Key patents protecting lenvatinib are projected to expire in the United States and Europe between 2026 and 2028, signaling the imminent arrival of generic competition.
• Current pricing, reflected by high WAC for Lenvima® capsules, is subject to substantial rebates and payer negotiations, resulting in a lower net price.
• Post-generic entry, prices for lenvatinib are projected to decline by 60-90% within 1-3 years, driven by increased market competition.
• Growth drivers include expanded indications and combination therapies, while challenges are dominated by intense competition, adverse events, high cost, and impending patent expiry.

Frequently Asked Questions

1. What is the primary mechanism of action for lenvatinib (NDC: 69315-0227)? Lenvatinib is a multi-targeted receptor tyrosine kinase inhibitor that blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors, fibroblast growth factor (FGF) receptors, platelet-derived growth factor receptor alpha (PDGFRα), RET proto-oncogene, and KIT proto-oncogene.

2. When is lenvatinib (NDC: 69315-0227) expected to face generic competition? Key patents for lenvatinib are anticipated to expire in the United States and Europe between 2026 and 2028, which is when generic versions are expected to enter the market.

3. How does the price of lenvatinib (NDC: 69315-0227) compare to its competitors? The wholesale acquisition cost (WAC) of lenvatinib is substantial, comparable to other novel oncology agents. However, net prices after significant rebates are more competitive. Its pricing relative to specific competitors varies by indication and payer negotiation.

4. What are the main indications for lenvatinib (NDC: 69315-0227)? Lenvatinib is approved for the treatment of differentiated thyroid cancer, advanced renal cell carcinoma (in combination regimens), and unresectable hepatocellular carcinoma.

5. What impact will generic entry have on the price of lenvatinib (NDC: 69315-0227)? Generic entry is projected to cause a significant price erosion for lenvatinib, with prices potentially falling by 60-90% within 1-3 years of generic availability due to increased market competition.

Citations

[1] Eisai Co., Ltd. (n.d.). Lenvima® (lenvatinib). Retrieved from [Manufacturer's Product Information website, specific URL would be provided here in a live document]

[2] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book database, specific search results would be provided here in a live document]