Last updated: February 27, 2026
What is the Drug Identified by NDC 00113-0189?
NDC 00113-0189 refers to Keytruda (pembrolizumab), a programmed death-1 (PD-1) immune checkpoint inhibitor. It is approved by the FDA for multiple oncology indications, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, and others.
Market Size and Demography
The global oncology drug market was valued at approximately $150 billion in 2021 and is expected to grow at a CAGR of 8% through 2028. Keytruda has consistently commanded a significant share, driven by approvals for new indications and increased adoption.
Key Oncology Indications for Keytruda:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Hodgkin lymphoma
- Microsatellite instability-high (MSI-H) cancers
Market Penetration:
- As of 2022, Keytruda holds around 45-50% of the US immunotherapy market share in oncology.
- The drug is available in over 120 countries, with the majority of revenue generated in North America, followed by Europe and Asia-Pacific.
Competitive Landscape
Keytruda’s primary competitors include:
- Opdivo (nivolumab) by Bristol-Myers Squibb
- Tecentriq (atezolizumab) by Roche
- Imfinzi (durvalumab) by AstraZeneca
These drugs have similar mechanisms and overlapping indications, intensifying market competition.
Market Dynamics:
- Patents for Keytruda are set to expire in 2028 for primary formulations, though growth is propelled by new indications and combination therapies.
- Regulatory approval for additional indications continues to expand the drug’s revenue potential.
Price Points and Reimbursement Landscape
Average Wholesale Price (AWP) and List Price:
| Indication |
Price per Dose |
Dosing Schedule |
| Melanoma (initial treatment) |
$10,000 - $12,500 per 200 mg dose |
200 mg every 3 weeks or 400 mg every 6 weeks |
| NSCLC (first-line) |
$10,000 - $13,000 per 200 mg dose |
200 mg every 3 weeks |
| Head and neck cancers |
Similar to melanoma/NSCLC prices |
200 mg every 3 weeks |
Reimbursement coverage varies:
- Commercial insurers typically reimburse at 80-100% of list price.
- Medicare and Medicaid negotiate discounts, potentially reducing payer costs by 20-40%.
Average Price Trends:
- List prices increased roughly 5% annually from 2018-2022.
- Price stabilizations are expected post-exclusivity expiration, barring new indication approvals or formulations.
Revenue Projections
Global Sales Forecast:
| Year |
Estimated Global Sales (USD billions) |
Assumptions |
| 2022 |
$8.0 |
Mature market penetration, multiple indications |
| 2025 |
$12.0 |
Expanded indications, increased acceptance |
| 2030 |
$15.0 |
Additional indications, potential biosimilar entry |
Key Growth Drivers:
- New approvals in gastric, liver, and other cancers.
- Combination therapies with chemotherapy or targeted agents.
- Expanding indications in earlier-line settings.
Risks:
- Patent expiration reduces exclusivity.
- Competition from biosimilars.
- Pricing pressures from payers and health authorities.
Regulatory and Patent Timeline
- Patent protection for original Keytruda formulations lasts until approximately 2028.
- Several biosimilar candidates are in development, aiming for approval around this period.
- Continued pursuit of new indications yields potential for market extension beyond patent expiration.
Summary of Market Outlook
The branded price per dose is expected to remain relatively stable in the short term due to ongoing demand, with slight increases driven by inflation and expanded indications. Post-2028, biosimilars could significantly reduce prices, impacting revenue.
Key Takeaways
- NDC 00113-0189 corresponds to Keytruda, a leading PD-1 inhibitor with a strong market position.
- The drug’s revenue is projected to increase through 2025, driven by new indications and expanded use.
- Price per dose ranges from $10,000 to $13,000, with reimbursement rates influencing net revenue.
- Patent expiration in 2028 may lead to biosimilar competition and price erosion.
- Regulatory approval of new indications and combination strategies remains critical for future growth.
FAQs
Q1: What are the main factors influencing Keytruda's pricing?
Reimbursement policies, competition, indication expansion, and manufacturing costs.
Q2: How soon could biosimilars impact Keytruda's prices?
Potentially starting in 2028 when patent expiry allows biosimilar entry.
Q3: Which indications generate the most revenue for Keytruda?
Melanoma and NSCLC account for the majority of sales, comprising approximately 70% of revenue.
Q4: What is the impact of regulatory approvals on market size?
Expanded approvals increase the eligible patient pool, boosting sales and revenue projections.
Q5: How are payers responding to high-cost immunotherapies?
Payers implement coverage restrictions, prior authorizations, and negotiate discounts to manage costs.
References
[1] MarketWatch. (2022). Oncology drugs market size and forecasts.
[2] IQVIA. (2022). Global Oncology Market Report.
[3] FDA. (2022). Drug approvals and indication expansions for pembrolizumab.
[4] EvaluatePharma. (2022). Oncology drug sales and trend analysis.
[5] FDA. (2020). Patent and exclusivity information for Keytruda.
