Last updated: March 9, 2026
What is NDC 29300-0389?
The drug with NDC 29300-0389 is Osimertinib (marketed as Tagrisso). It is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), approved by the FDA for non-small cell lung cancer (NSCLC) with specific EGFR mutations. It entered the market in 2018 and is manufactured by AstraZeneca.
Market Size and Key Drivers
Indication and Patient Population
- Approved for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or L858R mutations.
- Also approved for subsequent lines for T790M mutation-positive cases.
- Worldwide prevalence of EGFR mutations in NSCLC: approximately 10-15% in Western populations and up to 50% in Asian populations.
- Estimated global NSCLC incidence: 2.2 million cases annually (GLOBOCAN, 2020). EGFR mutation-positive subset: roughly 220,000–330,000 cases per year.
Competitive Landscape
- Main competitors: Erlotinib (Tarceva), Afatinib (Gilotrif), Gefitinib (Iressa).
- Osimertinib's advantages: superior progression-free survival (PFS), better CNS penetration, favorable safety profile.
- Market share reached 60-70% among EGFR inhibitors in 2022 (IQVIA data).
Revenue Data
- Global sales for Tagrisso reached approximately USD 5.6 billion in 2022.
- US accounted for about 60% of sales; other key markets include China, EU, and Japan.
- The drug's revenue grew at a compound annual growth rate (CAGR) of 18% from 2018-2022.
Pricing Analysis
Current Pricing
| Region |
Estimated Wholesale Acquisition Cost (WAC) per 30-day supply |
Additional Notes |
| US |
USD 16,000 – USD 17,500 |
Listed prices vary; discounts common |
| Europe |
EUR 12,000 – EUR 13,500 |
Prices negotiated with payers |
| China |
CNY 130,000 – CNY 150,000 |
Ironed out via negotiations |
| Japan |
JPY 1,800,000 – JPY 2,000,000 |
Price is regulated by authorities |
Price Trends and Projections
- Launch prices in 2018: USD 16,000/month in the US.
- Slight increases due to inflation and market dynamics, with potential discounts and rebates influencing net prices.
- Projected annual price increases in the US: 2-3% based on inflation, competitive pressures, and payer negotiations.
Future Pricing Outlook
- Introduction of biosimilar or generic versions unlikely before 2028 due to patent protections.
- Price stability expected until patent expiration.
- In emerging markets, prices are lower but are expected to increase due to expanding access and local pricing negotiations.
Regulatory and Patent Status
- Patent protection in the US expires in 2028. Pending patent challenges could influence timing.
- Patent extensions and supplementary patents may prolong exclusivity until 2030.
- Patent litigation and biosimilar entry will create downward pricing pressures post-2028.
Market Entry Barriers
- Strong patent protection.
- Clinical advantages over older EGFR inhibitors.
- Established payer coverage and formulary placement.
- Limited immediate generic competition.
Investment and R&D Outlook
- Continued pipeline expansion includes combinations with immunotherapies.
- Expectation of primary sales momentum till patent expiry.
- R&D efforts focus on earlier-stage NSCLC and resistant mutations.
Key Market Risks
- Biosimilar and generic competition in the US and Europe after 2028.
- Regulatory changes affecting pricing and reimbursement.
- Market saturation in key territories by 2025.
Conclusions
Osimertinib (NDC 29300-0389) remains a top-selling targeted therapy for NSCLC. Its dominance in the EGFR inhibitor space and patent protections support stable high pricing until 2028, with revenues projected to sustain at current levels or slightly grow until then. The landscape will shift post-patent expiry, likely driving significant price reductions and increased competition.
Key Takeaways
- Osimertinib generated USD 5.6 billion in global sales in 2022, maintaining growth trends.
- US prices hover around USD 16,000 per 30-day supply, with regional variations.
- Patent protection extends until at least 2028, limiting biosimilar competition.
- Market expansion in emerging markets is key for growth.
- Post-2028, expect price erosion driven by biosimilars and generics.
FAQs
Q1: When will Osimertinib face biosimilar competition?
A1: Post-2028, following patent expiration and patent challenge outcomes.
Q2: How do prices vary across regions?
A2: US prices are approximately USD 16,000/month; European prices are slightly lower, with China and Japan pricing influenced by negotiations and regulation.
Q3: What factors influence future price increases?
A3: Inflation, market expansions, and payer negotiations; however, significant increases are unlikely due to pricing pressures.
Q4: What is the sales outlook for Osimertinib over the next five years?
A4: Sales are expected to grow modestly, driven by expansion into new indications and markets until patent expiry.
Q5: How does Osimertinib compare to competitors?
A5: It has superior CNS activity, better safety, and higher efficacy, leading to dominant market share among EGFR inhibitors.
References
- GLOBOCAN. (2020). Global Cancer Statistics 2020. World Health Organization.
- IQVIA. (2022). The Global Use of Medicines in Oncology.
- AstraZeneca. (2022). Tagrisso (Osimertinib) Prescribing Information.
- FDA. (2018). Approved Drugs: Osimertinib (Tagrisso).
