Last updated: February 15, 2026
What is NDC 00378-6174?
NDC 00378-6174 refers to a specific pharmaceutical product, designated in the National Drug Code directory. According to the FDA and commercial drug databases, this NDC corresponds to Pemetrexed for Injection, 100 mg/vial. It’s approved for treating non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma.
Market Size and Demand Dynamics
Indications and Patient Population
Pemetrexed is primarily used in lung cancer and mesothelioma. The US market for lung cancer drugs reached approximately $3.7 billion in 2022[1], with Pemetrexed occupying a significant share, estimated at around 25-30% in the chemotherapy segment specific to NSCLC.
Market Trends
- Increasing Incidence: Lung cancer incidence in the US has grown modestly, contributing to steady demand.
- Treatment Landscape: The emergence of immunotherapies (e.g., PD-1 inhibitors) has introduced competition but Pemetrexed remains a standard component of combination regimens.
- Generic Entry: A key driver influencing pricing and market share is the expiration of patents. The brand Pemetrexed (brand name Alimta) lost exclusivity in some markets by 2021, leading to increased generic competition.
Competitive Landscape and Supply
Brand vs. Generic
- Since patent expiration, multiple generic manufacturers have entered the market. These manufacturers include Teva, Sun Pharma, and others who produce equivalent formulations.
- The overall market share of the original brand has decreased, with generics now accounting for approximately 70-80% of sales in the US.
Manufacturing and Supply Chain Considerations
- Pemetrexed is produced via complex chemical synthesis, requiring high-quality APIs.
- Suppliers with established manufacturing capacity and regulatory approval have competitive advantages.
- Recent supply chain disruptions have caused short-term price volatility but are stabilizing.
Price Projections
Historical Pricing
- Brand Name (Alimta): List price approximately $5,000–$7,000 per 100 mg vial (as of 2022).
- Generics: Prices range from $900 to $1,500 per vial, depending on manufacturer and contract negotiations.
Current Market Trends
- The entry of generics has decreased average transaction prices substantially.
- In 2022, average wholesale acquisition costs (WAC) for Pemetrexed were approximately $1,200 per vial for generic versions.
- Contract discounts and insurance negotiations reduce patient out-of-pocket costs further.
Projected Price Trajectory (2023–2027)
- Short Term (2023–2024): Expect prices for generic pemetrexed to stabilize around $1,200–$1,300 per vial, barring supply issues.
- Mid Term (2025–2027): Continued competition may exert downward pressure, with prices potentially falling to $900–$1,200 per vial.
- Premium pricing for branded formulations may persist in niche markets or regions with limited generic penetration but are unlikely to sustain pre-expiration levels.
Factors Influencing Future Prices
- Patent Litigation and Exclusivity: Any patent challenges or extensions could delay generic entry, maintaining higher prices temporarily.
- Regulatory Changes: New legislation incentivizing generic substitution could further drive prices down.
- Market Penetration of Biosimilars: While biosimilars pertain to biologics, no biosimilar exists for pemetrexed, which limits impact on pricing.
Regulatory and Policy Environment
- Medicare and Medicaid: Reimbursements may influence the net prices obtained by hospitals and clinics.
- Compulsory Licensing and Price Controls: Expected in certain jurisdictions, especially in emerging markets, which could lead to lower prices globally.
- Inflation and Manufacturing Costs: Anticipated increases in raw material costs could temper price declines.
Key Takeaways
- NDC 00378-6174 corresponds to generic pemetrexed, with prices trending downward due to increased competition.
- US market size for pemetrexed approximates $400–$600 million annually, with the potential for growth driven by incidence rates.
- Prices for generics are estimated around $900–$1,300 per vial, with brand prices significantly higher.
- Price declines are expected to continue over the next four years, influenced by patent expirations and market competition.
- Supply chain stability and regulatory developments will shape pricing trends.
FAQs
1. Will the price of NDC 00378-6174 decrease further?
Yes. Increased generic competition and potential biosimilar regulations will likely continue to drive prices downward.
2. How does market penetration of generics impact pricing?
Greater generic market share lowers average prices due to price competition and contract negotiations with payers.
3. What regions are experiencing the highest generic uptake for pemetrexed?
The US leads in generic adoption, with significant uptake also in Europe and several Asian markets.
4. Are biosimilars relevant to pemetrexed?
No. Biosimilars are not available for pemetrexed, as it is a small-molecule chemotherapy agent.
5. How might new indications or label expansions influence the market?
Expanded indications could increase demand, potentially stabilizing or increasing prices temporarily, especially before generic competition intensifies.
References
[1] IQVIA, "Pharmaceutical Market Dynamics," 2022.
