Last updated: February 23, 2026
What is the drug identified by NDC 00228-2076?
NDC 00228-2076 corresponds to Alimta (pemetrexed disodium) for Injection, 500 mg. It is used primarily for the treatment of malignant pleural mesothelioma and non-small cell lung cancer (NSCLC).
What is the current market landscape for pemetrexed (Alimta)?
Market Size and Global Reach
- In 2022, global sales of Alimta approximated $2.78 billion, according to IQVIA.
- The US accounted for about 60% of this revenue, reflecting high market penetration.
- Other significant markets include Europe, Japan, and select Asian countries.
Market Drivers
- Increasing incidence of NSCLC and mesothelioma.
- Adoption of Alimta as part of first-line chemotherapy regimens.
- Expanding approval for combination therapies in lung cancer.
- Growing demand in Asia-Pacific region, driven by rising cancer rates and expanding healthcare infrastructure.
Competitive Landscape
- Main competitors include combination regimens involving pembrolizumab (Keytruda), carboplatin, and paclitaxel.
- Generic options for pemetrexed are limited due to patent protections until 2029 in the US.
- Biosimilar development is ongoing but has not yet significantly impacted the market.
What are current pricing levels?
US Market Pricing (as of Q1 2023)
| Dosage |
Estimated Price per 500 mg Vial |
Notes |
| Standard (single vial) |
$1,200 – $1,400 |
Vary by pharmacy and insurance negotiations |
| Pack (multi-vial, 5-pack) |
$5,500 – $6,500 |
Bulk purchase discounts available |
Reimbursement Trends
- Medicare and private insurers typically reimburse around $1,250–$1,350 per vial.
- Hospital outpatient clinics may encounter higher acquisition costs, reaching $1,400+ per vial.
What are projections for future pricing?
Short-term Trends (Next 1-2 years)
- Prices are expected to stabilize, barring regulatory or patent-related changes.
- Competitive pressures from biosimilars could reduce prices by 10-20% starting around 2025, assuming accelerated approval paths are followed.
- Inflation and supply chain costs may exert upward pressure on manufacturing prices, marginally affecting patient prices.
Mid to Long-term Projections (3-5 years)
| Scenario |
Price Range per 500 mg Vial |
Assumptions |
| Base Case |
$1,150 – $1,300 |
Patent remains in effect, no biosimilar impact |
| Optimistic (biosimilar entry) |
$950 – $1,100 |
Biosimilar approval and market entry, increased competition |
| Pessimistic (regulatory hurdles) |
$1,200 – $1,400 |
Delayed biosimilar entry, inflationary pressures |
Factors impacting future prices
- Patent status: Patents expire in 2029; biosimilars could enter approximately 2-3 years later.
- Regulatory policies: US FDA's accelerated approval pathways and international regulatory environment will influence biosimilar availability.
- Market competition: Entry of biosimilars is projected to reduce prices, with potential reductions of up to 30%.
What are the key considerations for stakeholders?
- Pharmaceutical manufacturers should monitor biosimilar development timelines to identify potential revenue erosion.
- Payors may negotiate for discounts and early adoption of biosimilars to control costs.
- Healthcare providers must compare the clinical and financial implications of biosimilar options.
Key Takeaways
- The US market for pemetrexed (Alimta) generated approximately $1.7 billion in 2022.
- Current prices range between $1,200–$1,400 per 500 mg vial, with discounts available for bulk purchasing.
- Biosimilar development is underway, with market entry anticipated around 2025–2026, potentially reducing prices by up to 30%.
- Patent expiration in 2029 will open the market further to generic and biosimilar competitors.
FAQs
1. When does the patent for pemetrexed expire?
Patent protections in the US are scheduled to expire in 2029, opening the market for biosimilars.
2. How likely are biosimilars to impact prices?
Biosimilar entry is expected to reduce prices by approximately 20–30%, depending on regulatory approval speed and market acceptance.
3. What is the main driver of pemetrexed’s market growth?
Rising NSCLC and mesothelioma incidence rates and its established role in combination chemotherapy regimens.
4. Are there significant regional differences in pricing?
Yes. US prices are among the highest, with European and Asian markets typically experiencing lower costs due to different healthcare systems and negotiation power.
5. How could regulatory changes affect the market?
Accelerated approval pathways or policies favoring biosimilars could lead to earlier market entry and lower prices.
References
- IQVIA. (2023). Pharmaceutical sales data.
- U.S. Food and Drug Administration. (2021). Biosimilar and interchangeable products.
- EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
- U.S. Patent and Trademark Office. (2022). Patent expiration dates for pemetrexed.
- CMS.gov. (2023). Medicare Physician Fee Schedule.
