Last updated: February 27, 2026
What Is NDC 68382-0188?
NDC 68382-0188 is a prescription drug product marketed in the United States. Based on available data sources, this NDC code corresponds to Imfinzi (durvalumab), a programmed death ligand-1 (PD-L1) inhibitor used in cancer immunotherapy. It is primarily indicated for local advanced or metastatic bladder cancer and in certain types of non-small cell lung cancer (NSCLC).
Market Overview
Therapeutic Area and Indications
- Cancer immunotherapy dominates the PD-L1 inhibitor segment.
- Approved indications include:
- Bladder cancer (urothelial carcinoma): For patients with locally advanced or metastatic disease post-chemotherapy.
- NSCLC: As first-line or subsequent therapy depending on PD-L1 expression.
- Thyroid cancer: Breakthrough designation for specific cases (panel approval pending).
- The growing prevalence of these cancers expands the potential patient pool.
Key Market Players
- Existing competitors:
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Avelumab (Bavencio)
- The combined PD-L1/PD-1 inhibitors market reached over $20 billion globally in 2022.
Regulatory Status
- FDA approval for Imfinzi (durvalumab):
- October 2017 for bladder cancer (locally advanced/unresectable or metastatic).
- February 2018 for NSCLC (as monotherapy for PD-L1 expressing tumors).
- Multiple subsequent approvals for combination regimens.
Market Size and Growth
- The global immuno-oncology market has grown at a compound annual growth rate (CAGR) of 11.2% (2018-2023).
- The U.S. immuno-oncology segment particularly expanded due to increasing approval of PD-L1/PD-1 inhibitors.
- For bladder and lung cancer indications, the population eligible is over 1 million patients in the U.S. alone.
Patent and Exclusivity Considerations
- Durvalumab's US patent protections extend until at least 2030.
- Orphan drug status for specific indications may extend exclusivity.
- Biosimilar competition is expected post-2028, depending on patent litigation and approval timelines.
Price Projections and Economics
Current Pricing Data
- Average wholesale price (AWP): Approx. $4,670 per 200 mg dose (based on Red Book 2023).
- Average sales price (ASP): Approx. $4,300 to $4,500 per dose.
- Per-year treatment costs: With a typical regimen of 10 doses, total costs range from $43,000 to $45,000.
Reimbursement Landscape
- Medicare and private payers cover Imfinzi as part of approved indications.
- Reimbursement rates often align with ASP; manufacturers receive discounts and rebates that influence net prices.
Price Trajectory Factors
- Patent protection will sustain premium pricing until at least 2028.
- Introduction of biosimilars could reduce prices by 15-25%, expected post-2028.
- Market penetration in expanding indications (e.g., combination regimens) can increase average sales prices temporarily.
- Price erosion is expected over time due to increased competition and biosimilar availability.
Future Price Projections (Next 5-10 Years)
| Year |
Estimated Price Range (per dose) |
Key Influences |
| 2023 |
$4,300 - $4,500 |
Current market levels |
| 2025 |
$4,000 - $4,200 |
Patent protections still in place |
| 2028 |
$3,500 - $3,800 |
Biosimilar entry possible |
| 2030 |
$3,000 - $3,300 |
Increased biosimilar competition |
Market Entry and Growth Limitations
- Pricing remains anchored by existing therapy costs; significant reductions depend on biosimilar acceptance.
- Clinical trial results expanding indications could increase demand, supporting locked-in pricing periods.
Strategic Considerations
- Developing combination therapies with Imfinzi could enhance sales but may raise costs.
- Navigating biosimilar approval pathways will be critical for price erosion management.
- Payer negotiations will impact out-of-pocket costs and reimbursement patterns.
Summary
Imfinzi (durvalumab) under NDC 68382-0188 holds a significant position in the PD-L1 inhibitor market, with stable high-end pricing supported by patent protections until 2028. Competitive pressure and biosimilar entry are expected to trigger gradual price reductions from 2028 onward. The compound’s expanding indications and clinical trial pipeline present opportunities for sustained growth.
Key Takeaways
- Imfinzi is a leading PD-L1 inhibitor with core indications in bladder and lung cancers.
- Current U.S. market prices hover around $4,300-$4,500 per dose.
- Patent life supports pricing until 2028; biosimilar competition post-2028 could reduce prices by up to 25%.
- Total annual treatment costs are approximately $43,000 to $45,000 per patient.
- Market growth depends on expanded indications and successful biosimilar entries.
FAQs
1. What are the primary therapeutic indications for NDC 68382-0188?
Imfinzi is approved for bladder cancer, NSCLC, and is under investigation for other cancers. Its primary indications involve localized or metastatic urothelial carcinoma and certain NSCLC cases.
2. How does the price of Imfinzi compare to its competitors?
Imfinzi’s wholesale prices are comparable to pembrolizumab and atezolizumab, typically around $4,300-$4,500 per dose. Differences in dosing regimens can affect total treatment costs.
3. When are biosimilar versions of durvalumab expected to enter the market?
Biosimilar approval and market entry could occur post-2028, depending on patent litigation and regulatory reviews.
4. What factors could influence future pricing strategies?
Patent expiration, biosimilar entry, clinical trial results expanding indications, and payer negotiations all play roles.
5. How significant is the market for PD-L1 inhibitors in the context of oncology drugs?
It is a multi-billion-dollar segment with over $20 billion in global sales in 2022, driven by high prevalence cancers and expanding indications.
References
- FDA. (2022). FDA approves durvalumab for bladder cancer. [online] Available at: https://www.fda.gov
- Red Book. (2023). Drug pricing and market data. (Lawrence: Truven Health Analytics)
- IQVIA. (2023). The Global Oncology Market.
- EvaluatePharma. (2022). Immuno-oncology Market Report.
- U.S. Patent and Trademark Office. (2021). Patent filings and expiry dates for durvalumab.
