Last updated: February 24, 2026
What is NDC 70000-0080?
NDC 70000-0080 corresponds to Lorlatinib, a third-generation ALK and ROS1 tyrosine kinase inhibitor approved by the FDA in November 2018. It is used primarily for treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on other ALK inhibitors.
Market Overview
Indication and Adoption
- Primary indication: ALK-positive metastatic NSCLC.
- Target population: Approximately 3,000-4,000 new cases annually in the U.S., with potential expansion to off-label and broader oncologic uses.
- Market penetration: Limited initial adoption due to competition from other ALK inhibitors like alectinib and brigatinib; increasing as resistance develops and second-line options expand.
Competitive Landscape
| Drug Name |
Mechanism |
Approval Year |
Market Share (estimated 2023) |
Price (per 30-day supply) |
| Lorlatinib |
ALK/ROS1 inhibitor |
2018 |
15-20% |
$15,000 - $17,000 |
| Alectinib |
ALK inhibitor |
2015 |
50-55% |
$12,500 - $14,000 |
| Brigatinib |
ALK inhibitor |
2017 |
10-15% |
$14,000 - $16,000 |
| Ceritinib |
ALK inhibitor |
2014 |
<10% |
$13,000 - $15,000 |
Sales Trends and Forecasts
- 2018-2022: Sales grew gradually as the drug gained acceptance. Exact U.S. sales figures are undisclosed but estimated to reach $500 million by 2022.
- Projection for 2023-2028: Compound annual growth rate (CAGR) approximates 15-20%, driven by increased off-label use, expanded indications, and approval in additional markets.
Price Projections and Factors
Current Pricing
- The average wholesale price (AWP) for NDC 70000-0080 ranges from $15,000 to $17,000 per 30-day supply.
- Commercial payer discounts and negotiated prices lower these figures by 15-25%.
Short-term forecasts (2023-2025)
- Stable pricing: Due to patent protection until at least 2028, and limited generic competition, prices are expected to remain within the current range.
- Potential increases: Minor adjustments for inflation or market factors, possibly 3-5% annually.
Long-term outlook (2026-2030)
- Entry of generics: Patent expiry projected around 2028 in the U.S., opening the market to generic versions.
- Pricing decline: Entry of generics could reduce the price to $8,000 - $10,000 per 30-day supply within 1-2 years post-patent expiry.
- Market dynamics: Accelerated adoption of biosimilars or alternative therapies could further pressure prices downward.
External factors influencing price
- Insurance coverage policies: Increased formulary placement affects the negotiated price.
- Regulatory approvals: Expanded indications or cross-border approvals could influence market size and pricing.
- Global market dynamics: Emerging markets may see lower prices due to price controls; mature markets maintain higher prices.
Summary
| Aspect |
Details |
| Current price range |
$15,000 - $17,000 per 30-day supply |
| Price trend (2023-2025) |
Stable, with 3-5% annual increase possible |
| Post-patent expiry |
Potential decline to $8,000 - $10,000 |
| Sales potential (2023-2028) |
$750 million to $1.2 billion annually in select markets |
Key Takeaways
- NDC 70000-0080 (Lorlatinib) remains a high-priced, targeted treatment primarily for ALK-positive NSCLC.
- Market growth depends on increased adoption, expanding indications, and competition.
- Prices are expected to stabilize in the near-term, with significant declines after patent expiration.
- Emerging biosimilar or generic options could reshape the market landscape post-2028.
FAQs
1. When is patent expiration expected for Lorlatinib?
Patent protection is expected to expire around 2028 in the U.S.
2. How does Lorlatinib's price compare to other ALK inhibitors?
It is generally priced higher than alectinib but comparable to brigatinib, reflecting its newer status and targeted profile.
3. What factors could influence Lorlatinib's future market share?
Regulatory approvals for new indications, off-label use, and competition from biosimilars post-patent expiration.
4. Are there any generic versions available?
Not yet. Generics are anticipated around 2028, following patent expiry.
5. What is the primary driver for Lorlatinib’s sales growth?
Increased adoption as a second- or third-line therapy and expansion of indications beyond initial approval.
References
- Food and Drug Administration. (2018). Lorlatinib approval letter. https://www.fda.gov
- IQVIA. (2022). U.S. prescription drug sales data.
- EvaluatePharma. (2023). Global oncology drug market outlook.
- GoodRx. (2023). Average drug prices.
