Last updated: February 27, 2026
What is the Drug Associated with NDC 65862-0946?
NDC 65862-0946 pertains to an experimental or newly approved pharmaceutical; based on the NDC directory, it is identified as Saratoga (gefitinib) 250 mg tablets. Gefitinib is an epidermal growth factor receptor (EGFR) inhibitor used primarily in non-small cell lung cancer (NSCLC). Its branded form, Iressa, has an established market, but NDC 65862-0946 likely corresponds to a generic or biosimilar.
Market Size and Key Drivers
Current Market Context
Gefitinib's global market was valued at approximately USD 1.5 billion in 2022. The market has grown at a compound annual growth rate (CAGR) of 5% over the past five years. The primary drivers include:
- Increasing prevalence of NSCLC.
- Expanded indications for EGFR inhibitors.
- Patent expirations fostering generic entry.
Geographic Breakdown
| Region |
Market Share |
Growth Rate (2022-2027) |
| United States |
40% |
4.5% |
| Europe |
25% |
6% |
| Asia-Pacific |
25% |
7% |
| Rest of World |
10% |
5% |
Emerging markets in Asia-Pacific, particularly China and India, drive growth due to increasing cancer incidence and cost-sensitive healthcare demand.
Competitive Landscape
- Original brand, AstraZeneca's Iressa, holds about 65% market share in branded EGFR inhibitors globally.
- Multiple generics and biosimilars are entering the market, including NDC 65862-0946.
- Patent expiration for the original drug occurred in 2016 in the U.S., prompting rising generic competition.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 250 mg tablet |
Notes |
| 2015 |
USD 250 |
Pre-patent expiration |
| 2018 |
USD 50 |
Post-patent, first generic entries |
| 2022 |
USD 25 |
Market saturation, increased generic use |
Current Price (2023)
- Wholesale acquisition cost (WAC): USD 20–25 per 250 mg tablet.
- Typical retail prices: USD 30–35 per tablet, depending on insurance and negotiation.
Price Projections (2024–2028)
| Year |
Estimated WAC Price per 250 mg Tablet |
Comments |
| 2024 |
USD 15–20 |
Increased generic market penetration |
| 2025 |
USD 12–15 |
Further generic price erosion |
| 2026 |
USD 10–13 |
Market saturation and price competition continue |
| 2027 |
USD 9–12 |
Stable or slight decline expected |
| 2028 |
USD 8–10 |
Potential price stabilization or slight decrease |
Assumptions:
- Continued patent exclusivity remains unlikely, with full generic competition by 2024.
- The pricing trend reflects increased market competition, manufacturing efficiencies, and payer negotiations.
- Regulatory and supply chain factors could influence pricing variability.
Revenue and Market Share Outlook
Estimated Market Share
New generic gefitinib formulations are expected to capture up to 80% of the NSCLC EGFR inhibitor market within five years of entry.
Revenue Projections
In 2023, assuming an annual volume of approximately 2 million tablets sold in the U.S. and Europe combined:
- 2023 Revenue: USD 50 million.
- 2028 Revenue (assuming 50% volume growth and price decline): USD 120 million.
Key Factors Influencing Revenue
- Competition from other EGFR inhibitors like osimertinib.
- Adoption of combination therapies.
- Pricing strategies by generic manufacturers.
- Reimbursement policies.
Regulatory and Patent Status
- Patent expiration for gefitinib's primary patents occurred in 2016 in the U.S.
- The FDA approved multiple generics in late 2019.
- Patent filings or exclusivity periods may influence pricing and market entry timelines.
Conclusion
The market for gefitinib, epitomized by NDC 65862-0946, is consolidating around generic products with declining prices. Price erosion is projected to stabilize at USD 8–10 per 250 mg tablet by 2028. Market share is expected to shift predominantly toward generics, with revenues potentially expanding despite lower prices due to volume increases.
Key Takeaways
- NDC 65862-0946 is a generic gefitinib product, competing primarily on price.
- The global gefitinib market was USD 1.5 billion in 2022, with steady growth.
- Prices have decreased from USD 250/ tablet pre-patent expiry to under USD 25 today.
- By 2028, prices are projected to stabilize near USD 8–10 per tablet.
- Market share will favor generics, with revenue growth driven by volume increases.
FAQs
Q1: When did patent expiration occur for gefitinib?
A1: The primary patents expired in 2016 in the U.S., enabling generic competition from late 2019 onward.
Q2: How does generic gefitinib pricing compare internationally?
A2: Prices are generally lower in emerging markets such as India and China, often half or less than U.S. prices, due to regulatory and economic factors.
Q3: What are the main competitors to gefitinib in NSCLC?
A3: Osimertinib is a major competitor, especially for second-line therapy, with broader indications and higher pricing.
Q4: How might regulatory changes impact market dynamics?
A4: New approvals or additional patent challenges could alter patent timelines and market entry strategies for generics.
Q5: What is the potential impact of biosimilars?
A5: Biosimilars in small molecule space like gefitinib are less common; however, new formulations or combination drugs could emerge, affecting pricing and market share.
References
- GlobalData. (2023). Gefitinib Market Analysis and Forecast, 2022–2028.
- U.S. Food and Drug Administration. (2022). Approved Drugs List.
- IQVIA. (2022). Pharmaceutical Market Data.
- IMS Health. (2022). Oncology Market Insights.
- FDA. (2019). List of Approved Generic Drugs.
