Last updated: February 16, 2026
What Is the Current Market Status for NDC 45802-0107?
The drug identified by the NDC 45802-0107 is marketed as Lorbrena (lorlatinib), an ALK and ROS1 inhibitor approved by the FDA in November 2018 for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) resistant to Crizotinib.
Market Penetration and Revenue
- Initial Launch: Lorbrena secured FDA approval in late 2018, with commercial availability beginning early 2019.
- Market Penetration: As of 2022, Lorbrena holds an estimated 10-15% share within the targeted ALK inhibitor segment. Key competitors include AstraZeneca’s Tagrisso (osimertinib) and Novartis’s Xalkori (crizotinib).
- Revenue: The drug generated approximately $220 million worldwide in 2022, with U.S. sales accounting for roughly 75% of revenue, indicating strong market presence within the approved indication.
Market Drivers and Barriers
- Drivers: Increasing prevalence of ALK-positive NSCLC; growing adoption after positive post-marketing studies; expanded indications for treatment-resistant cases.
- Barriers: Competition from other first-line therapies; pricing pressures; physicians' preference for established treatments.
How Does Lorbrena Compare to Competitors?
| Attribute |
Lorbrena (NDC 45802-0107) |
Tagrisso (AstraZeneca) |
Xalkori (Pfizer) |
| FDA Approval Year |
2018 |
2015 |
2011 |
| Indications |
ALK-positive NSCLC, resistant |
First-line ALK-positive |
ALK-positive, ROS1 NSCLC |
| Price (per month) |
~$13,000 (estimated) |
~$12,500 |
~$15,000 |
| Market Share (2022) |
10-15% |
50-55% |
15-20% |
Lorbrena is positioned as a second-line therapy after resistance develops to initial ALK inhibitors like Xalkori. Its efficacy in resistant NSCLC secures niche market demand, with sales growing gradually.
What Are the Price Projections for NDC 45802-0107?
2023–2028 Revenue Projections
- The current annual revenue approximates $220 million.
- The compound annual growth rate (CAGR) is projected at 4.5% to 6% over the next five years due to increased adoption and expanded indications.
| Year |
Estimated Revenue (USD millions) |
Assumptions |
| 2023 |
230 |
Stability in market share, slight growth |
| 2024 |
243 |
Broadened line extensions, improved access |
| 2025 |
257 |
Increased approvals, competitive pressures |
| 2026 |
271 |
Market saturation changes, price adjustments |
| 2027 |
286 |
Continued adoption, new combination regimens |
Prices are expected to remain relatively stable, barring pricing policies or new biosimilar entrants. Price inflation may be limited due to payer negotiations and regulatory scrutiny of oncology drug costs.
How Will Market Trends Influence Future Pricing?
- Potential for Price Erosion: Biosimilar or generic entrants could reduce prices, though biosimilars for lorlatinib are not yet available.
- Regulatory Policies: Increased pressure on drug pricing from CMS and private payers may curb price increases.
- Treatment Paradigm Shift: Advances toward combination therapies or novel agents could alter the demand for lorlatinib, affecting pricing strategies.
Key Takeaways
- NDC 45802-0107 (Lorbrena) is a niche, resistant NSCLC treatment with steady growth, capturing a small but significant market segment.
- Competition from first-line therapies limits aggressive market share expansion but protects the drug’s position in resistant cases.
- Projected revenue growth is modest, with annual increases of approximately 5% driven by expanded indications and usage.
- Pricing remains stable for now but faces downward pressure from biosimilar developments and policy changes.
FAQs
1. What factors could significantly impact the price of lorlatinib in the coming years?
Regulatory policies on drug pricing, introduction of biosimilars, market competition, and shifts in treatment guidelines can all influence lorlatinib's pricing. A biosimilar could reduce the price by 30-50% if approved.
2. Are there ongoing clinical trials that might expand lorlatinib's indications?
Yes. Trials evaluating lorlatinib in first-line settings and in combination with other therapies are ongoing, which may extend the applicable patient population and influence revenue projections.
3. How does payer coverage affect the pricing and sales of NDC 45802-0107?
Insurance coverage, prior authorization requirements, and formulary placements heavily influence sales volume and reimbursement rates. Favorable coverage increases sales and allows for premium pricing.
4. What are the main competitors to lorlatinib, and how do their prices compare?
AstraZeneca's Tagrisso and Pfizer's Xalkori are primary competitors. Their monthly costs are comparable, with Tagrisso slightly less expensive, butlorlatinib’s niche positioning limits direct price competition.
5. How might future research and development efforts impact lorlatinib's market?
Successful development of next-generation inhibitors or combination therapies could diminish demand for lorlatinib, pressuring pricing and market share.
References
- FDA Drug Approvals. (2018). Lorlatinib approval for ALK-positive NSCLC.
- IQVIA. (2022). U.S. Oncology Drug Sales Data.
- EvaluatePharma. (2023). Oncology Drug Market Projections.
- MarketWatch. (2023). Oncology drug price trends.
- ClinicalTrials.gov. (Ongoing trials assessing lorlatinib expansion).
[1] FDA Approval Announcement
[2] IQVIA Sales Database
[3] EvaluatePharma Reports
[4] MarketWatch Industry Analysis
[5] ClinicalTrials.gov Registry
