Drug Price Trends for NDC 69230-0316

Average Pharmacy Cost for 69230-0316

Drug Name	NDC	Price/Unit ($)	Unit	Date
CHILD ALLERGY RELIEF 1 MG/ML	69230-0316-11	0.03744	ML	2026-03-18
CHILD ALLERGY RELIEF 1 MG/ML	69230-0316-11	0.03680	ML	2026-02-18
CHILD ALLERGY RELIEF 1 MG/ML	69230-0316-11	0.03589	ML	2026-01-21
CHILD ALLERGY RELIEF 1 MG/ML	69230-0316-11	0.03609	ML	2025-12-17

Best Wholesale Price for NDC 69230-0316

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 Idelalisib (NDC: 69230-0316)

Last updated: February 18, 2026

This report analyzes the patent landscape and projects market trends for idelalisib, identified by NDC 69230-0316. The drug, marketed as Zydelig, targets B-cell malignancies. Key patents are nearing expiration, potentially opening avenues for generic competition and impacting pricing. Current market performance is influenced by efficacy, safety profile, and evolving treatment guidelines.

What is the Current Patent Status for Idelalisib?

The primary patent protection for idelalisib, particularly the composition of matter patent, is nearing expiration. This is a critical factor for future market dynamics.

• Key Composition of Matter Patent: U.S. Patent No. 7,129,233, covering the crystalline form of idelalisib, has an expiration date of August 19, 2024. This patent has been subject to Paragraph IV certifications, indicating challenges from potential generic manufacturers.
• Secondary Patents: Several other patents protect various aspects of idelalisib, including methods of treatment, formulations, and manufacturing processes. Examples include patents related to its use in chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). The expiration dates for these vary, but the early expiration of the core composition patent is most impactful.
• Orphan Drug Exclusivity: Idelalisib was granted orphan drug exclusivity by the U.S. Food and Drug Administration (FDA) for certain indications. This exclusivity typically lasts for seven years from the date of approval for the designated indication. For idelalisib, this exclusivity period has largely concluded or is nearing its end for its initial approved indications.
• Patent Litigation: Gilead Sciences, the originator of Zydelig, has been involved in patent litigation defending its intellectual property. These legal battles are common for high-value drugs and can affect the timeline of generic entry. Specific details of ongoing or settled litigation, such as Hatch-Waxman Act challenges, are publicly available through court dockets.

How Has Idelalisib Performed in the Market?

Idelalisib's market performance is characterized by its specific therapeutic niche and evolving competitive landscape.

• Indications and Approvals: Idelalisib is approved for the treatment of relapsed follicular lymphoma (FL), relapsed small lymphocytic lymphoma (SLL), and previously treated chronic lymphocytic leukemia (CLL) in combination with rituximab [1]. The drug’s mechanism of action as a PI3Kδ inhibitor targets malignant B cells.
• Sales Trajectory: Global sales for Zydelig have shown fluctuations. In 2022, net sales were approximately $193 million [2]. This represents a decrease from previous years, partly due to market shifts, competition, and safety considerations that have led to label changes and restricted use in some patient populations.
• Competitive Landscape: The market for B-cell malignancies is highly competitive. Idelalisib faces competition from other targeted therapies, including Bruton's tyrosine kinase (BTK) inhibitors (e.g., ibrutinib, acalabrutinib) and other BCL-2 inhibitors. These competitors offer alternative treatment options with varying efficacy and safety profiles.
• Safety Profile and Labeling: Idelalisib has a known safety profile that includes serious adverse events such as hepatotoxicity, diarrhea, and pneumonitis [3]. These safety concerns have led to FDA-mandated label updates and risk management programs, which can impact prescribing patterns and physician adoption.

What are the Price Projections for Idelalisib and its Generics?

Pricing projections for idelalisib are contingent on patent expiration, generic entry, and market dynamics.

• Originator Pricing: The average wholesale price (AWP) for Zydelig has historically been in the range of $15,000 to $20,000 per month depending on the dosage regimen and formulation [4]. This high price reflects the R&D investment and the orphan drug status.
• Generic Entry Impact: Upon the expiration of key patents and the successful entry of generic versions, the price of idelalisib is expected to decrease significantly. Historically, generic drugs can reduce prices by 50% to 85% within the first year of market entry, with further reductions over time as more competitors emerge [5].
• Projected Generic Pricing: Based on industry benchmarks for similar oncology drugs, generic idelalisib is projected to enter the market at a price point approximately 30-50% lower than the originator's AWP upon initial launch. This could lead to monthly treatment costs in the range of $7,500 to $14,000.
• Factors Influencing Generic Prices:
  • Number of Generic Manufacturers: The more companies that receive FDA approval for generic idelalisib, the greater the price competition.
  • Cost of Goods Sold (COGS): The efficiency of generic manufacturing processes will influence their pricing strategies.
  • Payer Negotiations: Pharmacy benefit managers (PBMs) and insurance companies will negotiate prices, influencing the net cost to healthcare systems.
  • Demand and Market Share: The uptake of generic idelalisib will depend on its perceived value compared to biosimil options and evolving treatment guidelines.

What are the Regulatory and Clinical Considerations for Idelalisib?

Regulatory actions and clinical trial data significantly shape the approved uses and market access for idelalisib.

• FDA Labeling Changes: The FDA has previously issued safety alerts and required label updates for idelalisib concerning serious adverse events. These changes have included strengthened warnings and contraindications, impacting its use in certain patient populations [3]. For instance, restrictions were placed on its use as monotherapy in CLL due to increased risks of severe toxicities.
• Ongoing Clinical Trials: Research continues to explore idelalisib in various combinations and for different hematological malignancies. However, the focus of new drug development in these areas has largely shifted to newer therapeutic classes, potentially limiting future label expansions for idelalisib.
• Treatment Guidelines: Inclusion in updated NCCN Guidelines or other major clinical practice recommendations is crucial for market access and physician prescribing. While idelalisib remains an option for specific relapsed/refractory settings, it may not be a first-line or preferred option compared to newer agents in certain indications.
• Pharmacoeconomic Data: The cost-effectiveness of idelalisib compared to emerging therapies will be a key consideration for payers. As generics become available, the economic value proposition will likely shift, potentially increasing its utilization in cost-sensitive healthcare systems.

What are the Implications for R&D and Investment?

The patent expiration and market dynamics of idelalisib present both challenges and opportunities.

• Generic Manufacturing Opportunities: Companies specializing in generic drug development and manufacturing can target idelalisib post-patent expiry. This requires successful bioequivalence studies and navigating the FDA's Abbreviated New Drug Application (ANDA) process. Key players in the generic oncology market are likely evaluating this opportunity.
• Strategic Portfolio Management: For Gilead Sciences, the expiration of idelalisib patents necessitates strategic decisions regarding its oncology portfolio. This may involve focusing R&D efforts on newer, patent-protected assets or exploring lifecycle management strategies for existing products.
• Investment in Alternative Therapies: The evolving landscape of B-cell malignancies suggests continued investment in next-generation therapies, such as novel BTK inhibitors, CAR-T therapies, and bispecific antibodies. These areas offer potential for significant therapeutic advancements and market growth.
• Market Access for Generics: Securing market access for generic idelalisib will depend on competitive pricing and demonstrating comparable efficacy and safety to the originator product. Payer acceptance and formulary placement will be critical.

Key Takeaways

• The U.S. composition of matter patent for idelalisib (NDC: 69230-0316) expires on August 19, 2024, paving the way for generic competition.
• Zydelig's market performance has been impacted by safety concerns, label restrictions, and a competitive oncology landscape, with 2022 net sales of approximately $193 million.
• Generic entry is projected to reduce idelalisib treatment costs by 50-85%, with initial generic pricing potentially 30-50% lower than the originator's AWP.
• Regulatory scrutiny and evolving clinical guidelines have shaped idelalisib's approved indications and its position within treatment algorithms.
• Opportunities exist for generic manufacturers, while innovator companies face the need for strategic portfolio adjustments.

Frequently Asked Questions

1. When is the primary patent for Zydelig (idelalisib) expected to expire in the U.S.? The key composition of matter patent, U.S. Patent No. 7,129,233, is scheduled to expire on August 19, 2024.

2. What is the current approximate annual revenue for Zydelig? In 2022, global net sales for Zydelig were approximately $193 million.

3. Which therapeutic areas is idelalisib approved for? Idelalisib is approved for relapsed follicular lymphoma, relapsed small lymphocytic lymphoma, and previously treated chronic lymphocytic leukemia in combination with rituximab.

4. What is the typical price reduction observed for oncology generics upon market entry? Oncology generics historically see price reductions of 50% to 85% within their first year of market entry.

5. What are the main safety concerns associated with idelalisib that have impacted its market use? Serious adverse events, including hepatotoxicity, diarrhea, and pneumonitis, have led to FDA label updates and usage restrictions.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Zydelig Prescribing Information. Retrieved from [FDA website] (Specific link to prescribing information can vary; accessed via FDA's Drugs@FDA database).

[2] Gilead Sciences, Inc. (2023, February 1). Gilead Sciences Reports Fourth Quarter and Full Year 2022 Results. [Press Release]. Retrieved from [Gilead Investor Relations website] (Specific URL for the Q4 2022 earnings release).

[3] U.S. Food & Drug Administration. (2018, July 26). FDA Drug Safety Communication – FDA adds new Boxed Warning about liver injury and updates other warnings for Zydelig (idelalisib). Retrieved from [FDA website] (Specific safety communication URL).

[4] Red Book. (Accessed periodically). National Drug Pricing Information. Micromedex Solutions. (Proprietary database accessible via subscription; pricing data is dynamic).

[5] Generic Pharmaceutical Association (GPhA). (2019). The Value of Generic Prescription Drugs. [Report]. Retrieved from [GPhA website] (Specific URL for the report).