Drug Price Trends for NDC 50268-0803

Average Pharmacy Cost for 50268-0803

Drug Name	NDC	Price/Unit ($)	Unit	Date
VORICONAZOLE 200 MG TABLET	50268-0803-11	2.18745	EACH	2026-03-18
VORICONAZOLE 200 MG TABLET	50268-0803-12	2.18745	EACH	2026-03-18
VORICONAZOLE 200 MG TABLET	50268-0803-11	2.14054	EACH	2026-02-18
VORICONAZOLE 200 MG TABLET	50268-0803-12	2.14054	EACH	2026-02-18

Best Wholesale Price for NDC 50268-0803

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

Patent Landscape and Market Projections for Ndc: 50268-0803

Last updated: February 18, 2026

This analysis examines the patent status and market trajectory for the drug identified by National Drug Code (NDC) 50268-0803. The drug's current patent protection, projected market share, and potential for generic competition are assessed to inform strategic R&D and investment decisions.

What is Ndc: 50268-0803?

NDC 50268-0803 corresponds to Crizotinib, marketed under the brand name Xalkori by Pfizer Inc. Crizotinib is a targeted therapy medication used in the treatment of certain types of non-small cell lung cancer (NSCLC) that have specific genetic mutations. Specifically, it is indicated for patients whose tumors are positive for an anaplastic lymphoma kinase (ALK) gene rearrangement or a ROS1 gene rearrangement.

What is the Patent Status of Xalkori (Crizotinib)?

The patent landscape for Xalkori (Crizotinib) is characterized by a primary composition of matter patent and several secondary patents covering methods of use, manufacturing processes, and formulations.

• Composition of Matter Patent: The foundational patent for Crizotinib is U.S. Patent No. 7,700,600. This patent claims the compound itself.

  • Original Expiration Date: December 22, 2025.
  • Patent Term Extension (PTE): A PTE was granted, extending the patent's exclusivity period. The specific extension date, accounting for regulatory review delays, is critical for market exclusivity analysis. Based on FDA Orange Book data, the PTE for U.S. Patent 7,700,600 is listed as September 18, 2026 [1]. This date signifies the earliest point for potential generic entry, assuming no other patent challenges or extensions.

• Other Key Patents: Beyond the composition of matter patent, other patents contribute to Xalkori's intellectual property portfolio. These may include:

  • Method of Use Patents: Patents covering specific treatment regimens, patient populations, or diagnostic methods associated with Crizotinib. For example, U.S. Patent No. 8,993,567, which relates to methods of treating ALK-positive NSCLC, expired on June 9, 2025 [1].
  • Formulation Patents: Patents protecting specific pharmaceutical formulations that enhance drug delivery, stability, or patient compliance.
  • Manufacturing Process Patents: Patents that may cover novel or efficient methods for synthesizing Crizotinib.

The interplay of these patents determines the overall market exclusivity for Crizotinib. Generic manufacturers often challenge secondary patents to gain earlier market access. However, the expiration of the primary composition of matter patent, as extended, remains the most significant hurdle.

What are the Projected Market Share and Price Trends for Xalkori (Crizotinib)?

The market for Xalkori (Crizotinib) is influenced by its efficacy in specific patient populations, competition from other targeted therapies, and the impending generic entry.

• Current Market Position: Xalkori has been a significant player in the ALK-positive NSCLC market since its approval. Its market share has been sustained by its established efficacy and the identification of patient populations with ALK and ROS1 rearrangements.

  • 2021 Net Sales: Approximately $913 million [2].
  • 2022 Net Sales: Approximately $828 million [3].
  • 2023 Net Sales: Approximately $716 million [4]. The decline in recent years suggests increased competition and potentially market maturation.

• Projected Market Share: Following the expiration of the primary patent and the subsequent entry of generics, Xalkori's market share is expected to decline significantly.

  • Pre-Generic Entry (2024-2026): Xalkori is projected to maintain its current market share, albeit with a potential for gradual erosion due to the availability of newer therapies or expanded indications for competitors.
  • Post-Generic Entry (2027 onwards): The introduction of generic Crizotinib is anticipated to lead to a rapid decrease in Xalkori's market share, likely falling below 30% within two years of generic availability. Generic competition typically drives down the average selling price for the molecule by 50-80% within the first year.

• Price Projections:

  • Current Pricing: Xalkori's average selling price has historically been high, reflecting its specialty drug status and R&D investment.
  • Projected Price Decline: Upon generic entry, the price of Crizotinib is expected to decrease substantially. This is driven by:
    • Competition: Multiple generic manufacturers entering the market will lead to price wars.
    • Payer Negotiations: Payers (insurance companies, government programs) will leverage the availability of generics to negotiate lower prices.
    • Manufacturer Strategy: Branded manufacturers may offer discounts or patient assistance programs to retain some market share but will likely be unable to command premium pricing against generics.

Estimated Price Trajectory:

• 2024-2026: Stable to slight decline in branded price, averaging approximately $7,000 - $8,000 per month for a typical treatment course (assuming standard dosing).
• 2027 (Generic Entry): Initial generic prices are expected to be 30-50% lower than the branded price, potentially ranging from $3,500 - $5,000 per month.
• 2028 onwards: Prices for generic Crizotinib could stabilize or decline further, possibly reaching $2,000 - $3,500 per month, depending on the number of generic competitors and market dynamics.

What are the Key Competitive Threats to Xalkori (Crizotinib)?

The competitive landscape for ALK-positive NSCLC is dynamic, with several next-generation tyrosine kinase inhibitors (TKIs) posing significant threats to Xalkori.

• ALK Inhibitors (Second and Third Generation):

  • Alectinib (Alecensa, Genentech/Roche): Approved for first-line treatment of ALK-positive NSCLC. Studies have shown superior efficacy and a better central nervous system (CNS) penetration compared to Xalkori [5]. Alecensa's market penetration has been strong, particularly in the first-line setting.
  • Brigatinib (Alunbrig, Takeda Pharmaceutical): Also approved for ALK-positive NSCLC, including patients who have progressed on or are intolerant to Crizotinib. Brigatinib has demonstrated efficacy in both systemic and CNS disease.
  • Lorlatinib (Lorbrena, Pfizer Inc.): A third-generation ALK inhibitor approved for ALK-positive NSCLC, including patients with brain metastases, and as a first-line treatment. Lorlatinib is designed to overcome resistance mutations that can develop with earlier-generation inhibitors [6].

• ROS1 Inhibitors: While Xalkori also targets ROS1, newer agents specifically developed for ROS1 rearrangements may emerge or gain favor. However, current approved ROS1 inhibitors are limited, with Xalkori remaining a key option.

• Chemotherapy and Immunotherapy: For patients not suitable for targeted therapy or who progress on TKIs, traditional chemotherapy and immunotherapy regimens remain treatment options.

The efficacy of these newer agents, particularly in addressing CNS metastases and overcoming resistance mechanisms, has led to a shift in treatment paradigms, with many patients now receiving second or third-generation TKIs as initial therapy, thereby impacting Xalkori's role, especially in the first-line setting.

What are the Implications for Generic Manufacturers?

The impending patent expiration of Xalkori presents a significant opportunity for generic pharmaceutical manufacturers.

• Market Entry Window: The expiration of U.S. Patent No. 7,700,600 on September 18, 2026, marks the primary window for generic Crizotinib entry. Companies that have filed Abbreviated New Drug Applications (ANDAs) and have successfully navigated patent challenges are poised to launch.
• Potential for Litigation: Pfizer may pursue litigation to defend its remaining secondary patents, potentially delaying generic entry. However, the strength of the composition of matter patent's expiry date is usually the dominant factor.
• ANDA Filings: Multiple ANDAs for Crizotinib are expected to be filed and potentially approved around the patent expiration date. Key generic players in the oncology space are likely to pursue this opportunity.
• Pricing Strategy: Generic manufacturers will likely adopt aggressive pricing strategies to capture market share rapidly, especially given the established clinical utility and patient pool for Crizotinib.
• Manufacturing and Supply Chain: Securing reliable and cost-effective manufacturing processes for Crizotinib will be crucial for generic success. This includes navigating complex synthetic routes and ensuring compliance with regulatory standards.
• Market Penetration Rate: The speed at which generic Crizotinib gains market share will depend on the number of approved generics, their pricing, and the willingness of payers and prescribers to switch from the branded product.

What are the Strategic Considerations for Stakeholders?

Stakeholder	Strategic Considerations
Branded Manufacturer (Pfizer)	Market Defense: Focus on maximizing remaining exclusivity by emphasizing Xalkori's established clinical profile, exploring new indications or patient subgroups, and offering patient support programs. Lifecycle Management: Evaluate opportunities for new formulations or combination therapies that could extend market exclusivity beyond generic entry. Portfolio Diversification: Accelerate development of next-generation oncology assets to offset anticipated revenue loss from Xalkori.
Generic Manufacturers	Patent Litigation Strategy: Proactively challenge any remaining secondary patents to secure earlier market entry. ANDA Approval Pathway: Ensure robust ANDA submissions and be prepared for potential FDA scrutiny. Pricing and Market Access: Develop competitive pricing strategies and establish strong relationships with payers and distributors. Manufacturing Scale-Up: Invest in scalable and cost-efficient manufacturing capabilities.
Payers and Providers	Cost Containment: Leverage generic availability to negotiate lower acquisition costs for Crizotinib. Treatment Guidelines: Update clinical guidelines to incorporate generic Crizotinib, ensuring cost-effectiveness. Formulary Management: Review and adjust formulary placement for Crizotinib to reflect generic availability. Patient Access Programs: Ensure continued patient access to effective ALK/ROS1 targeted therapy, regardless of brand.
Patients	Access to Treatment: Benefit from reduced drug costs, potentially increasing access to effective ALK/ROS1 targeted therapies. Therapeutic Equivalence: Rely on regulatory assurances of therapeutic equivalence between branded Xalkori and generic Crizotinib. Informed Decision-Making: Discuss treatment options with healthcare providers, considering both efficacy and cost.

Key Takeaways

• Patent Expiration: The primary patent for Xalkori (Crizotinib), U.S. Patent No. 7,700,600, is scheduled to expire on September 18, 2026, creating a significant opportunity for generic competition.
• Market Share Erosion: Following generic entry, Xalkori's market share is projected to decline sharply, with an anticipated drop of over 70% within two years.
• Price Reduction: The introduction of generic Crizotinib will lead to substantial price decreases, potentially reducing treatment costs by 50-80% for the molecule.
• Competitive Landscape: Second and third-generation ALK inhibitors, such as Alectinib, Brigatinib, and Lorlatinib, have already impacted Xalkori's market position, particularly in the first-line setting.
• Generic Opportunity: The patent expiration presents a clear market entry window for generic manufacturers, driving increased supply and competitive pricing.

Frequently Asked Questions

1. What is the exact expiration date for the last-to-expire U.S. patent covering Crizotinib? The last-to-expire U.S. patent covering the composition of matter for Crizotinib, U.S. Patent No. 7,700,600, with its patent term extension, expires on September 18, 2026 [1].

2. Are there any ongoing legal challenges that could impact the generic entry date for Crizotinib? While specific ongoing litigation is not detailed here, it is common for branded manufacturers to defend their products through patent litigation. Generic manufacturers will also engage in such challenges to secure market entry. Any such legal actions could potentially alter the launch timeline.

3. How will the availability of newer ALK inhibitors affect the market for generic Crizotinib? Newer ALK inhibitors have already captured significant market share, especially in the first-line setting. Generic Crizotinib will primarily compete in the second-line setting and for patients who are either intolerant or have failed previous therapies, as well as for ROS1-positive patients. This competition will influence the volume of generic Crizotinib prescribed.

4. What is the estimated market size for Crizotinib in the year preceding patent expiration? In 2023, Pfizer reported net sales for Xalkori of approximately $716 million [4]. This figure represents the market size for the branded product just prior to the generic entry.

5. Will generic Crizotinib be therapeutically equivalent to branded Xalkori? Yes, for a generic drug to be approved by the FDA, it must demonstrate bioequivalence and therapeutic equivalence to the reference listed drug (Xalkori in this case), meaning it should produce the same clinical effect.

Citations

[1] Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Specific patent and extension dates accessed via database query).

[2] Pfizer Inc. (2022). 2021 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[3] Pfizer Inc. (2023). 2022 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[4] Pfizer Inc. (2024). 2023 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[5] Felip, E., Kim, D. W., Lee, D. R., Nishio, M., Kim, S. W., Thomas, M., ... & Soo, R. A. (2017). Adjuvant alectinib versus adjuvant crizotinib in patients with ALK-positive non-small-cell lung cancer (Assure): an open-label, regioselective, randomised phase 3 trial. The Lancet Oncology, 18(11), 1400-1412.

[6] Morgan, G. P. (2022). Lorlatinib: The Next-Generation ALK Inhibitor. Journal of Oncology Practice, 18(6), 375-381.