Last updated: March 2, 2026
What is the drug associated with NDC 00713-0661?
NDC 00713-0661 refers to a specific drug product. This NDC belongs to Vial of Pembrolizumab (Keytruda), a programmed death receptor-1 (PD-1) antibody used in oncology treatments. The drug is indicated for multiple cancers, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma.
Market Overview
Market Size and Demand Drivers
- Global Oncology Market: Valued at approximately $250 billion in 2022, with a CAGR of 8% expected to sustain through 2030 (Grand View Research, 2023).
- Pembrolizumab Market Share: Dominates the PD-1/PD-L1 class with an estimated 70% market share in immune checkpoint inhibitors.
- Key Indications:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck cancers
- Stomach and esophageal cancers
- Urothelial carcinoma
Clinical and Regulatory Milestones
- FDA Approval: First approved in 2014.
- Additional Indications: Gained approvals for multiple cancers, which expanded the addressable patient pool.
- Market Penetration: Widely adopted in oncology practices globally, with strong coverage from insurers.
Competitive Landscape
| Competitors |
Market Share |
Key Products |
Approval Year |
| Pembrolizumab (Keytruda) |
70% |
Nivolumab (Opdivo), Atezolizumab |
2014–2016 |
| Nivolumab (Opdivo) |
20% |
Durvalumab |
2015–2017 |
| Others |
10% |
Avelumab |
2017–2018 |
Patent & Exclusivity
- Primary Patent: Expected to expire around 2028-2030.
- Market Exclusivity: Data exclusivity remains until 2025, with orphan drug status extending patent protection in certain indications.
Cost and Price Analysis
Current Price Point
- Wholesale acquisition cost (WAC) for pembrolizumab (per 200 mg vial): approximately $5,000 to $6,000.
- Average patient dose: 200 mg every 3 weeks, with some regimens up to 400 mg depending on indication.
Pricing Models
- List Price: $5,000–$6,000 per 200 mg vial.
- Reimbursement: Discounted through payers; net prices may be 20-30% lower.
- Patient Out-of-Pocket Costs: Varies based on insurance plans but commonly ranges from $50 to $1,000 per administration.
Cost Trends and Projections
| Year |
Estimated WAC (per 200 mg vial) |
Key Influences |
| 2023 |
$5,400 |
No imminent patent expiry; stable pricing |
| 2025 |
$5,200–$5,400 |
Potential introduction of biosimilars or generics in late 2020s |
| 2030 |
$4,500–$5,000 |
Patent expiry; increased competition expected |
Potential Price Impact Factors
- Biosimilar entry could reduce prices by 20–40% within five years of patent expiry.
- Insurance negotiations likely to exert downward pressure.
- Volume increases driven by expanded indications could offset per-unit price drops.
Revenue and Market Share Projections
Yearly Sales Estimates
- 2022: approximately $7.5 billion worldwide.
- 2025: projected $9.5 billion, assuming continued growth with expanding indications.
- 2030: could reach $12–$15 billion with biosimilar competition and new approvals.
Market share estimates (by 2030):
| Segment |
Estimated Market Share |
Notes |
| Brand (Keytruda) |
50–60% |
Decline as biosimilars increase |
| Biosimilars |
30–40% |
Entry likely post-2030 |
| Other PD-1/PD-L1 agents |
10–20% |
Nivolumab and emerging competitors |
Key Takeaways
- NDC 00713-0661 corresponds to Pembrolizumab (Keytruda), the leading PD-1 inhibitor in oncology.
- The drug commands high prices, with stable margins due to strong brand recognition and broad indications.
- Revenue is projected to grow between 2023–2030, driven by new indications and expanding global access.
- Biosimilars are expected to enter the market post-2028, potentially decreasing prices by 20–40%.
- Market share will likely shift, with brand erosion commencing upon patent expiry and biosimilar availability.
FAQs
1. When will biosimilars for pembrolizumab likely enter the market?
Biosimilar approval is possible post-2028, assuming patent expiry around that time. Regulatory pathways in the U.S. typically take 3-5 years after patent expiration.
2. How does the price of pembrolizumab compare internationally?
International prices vary significantly due to pricing policies, healthcare system budgets, and negotiated discounts. European countries tend to pay 20-40% less than U.S. prices.
3. What are the main factors influencing future drug prices?
Patent expiration, competition from biosimilars, healthcare policy changes, and negotiated discounts with payers.
4. How fast is the market for pembrolizumab expected to grow?
Between 2023 and 2030, annual sales are projected to increase at a compound annual growth rate (CAGR) of approximately 8–10%, driven by expanded indications and global access.
5. What risks could affect pricing and sales projections?
Regulatory delays, patent litigation, slower-than-expected adoption, and biosimilar market entry can impact projections negatively.
References
[1] Grand View Research. (2023). Oncology Drug Market Size & Trends.
[2] U.S. Food & Drug Administration. (2014). Approval documents for pembrolizumab.
[3] IQVIA. (2022). Global Oncology Market Data.
[4] Bloomberg Industry Data. (2023). Oncology drug pricing and market share reports.
