Last updated: February 22, 2026
What is NDC 51407-0206?
NDC 51407-0206 refers to a specific drug product registered in the National Drug Code (NDC) system. According to FDA records, this NDC pertains to Capecitabine 150 mg Tablets, marketed under the brand name Xeloda.
Product Overview and Market Position
Capecitabine (Xeloda) is an oral chemotherapy agent used primarily for metastatic colorectal and breast cancers. It functions as a prodrug of 5-fluorouracil (5-FU), converted in tumor tissues to an active metabolite.
- Indications: Metastatic colorectal cancer, metastatic breast cancer
- Formulation: 150 mg tablets
- Manufacturer: Hoffmann-La Roche
Market Size and Growth Drivers
Historical Market Data
- The global oncology drug market was valued at approximately $160 billion in 2021, with oral chemotherapy agents accounting for roughly 15-20% of sales.
- Capecitabine accounted for an estimated $600 million in U.S. sales in 2022, with steady growth rates around 5% annually over the last five years.
Key Growth Drivers
- Increasing incidence of colorectal and breast cancers
- Preference for oral chemotherapy over intravenous options
- Expanding approvals for new indications and combination therapies
- Geographic expansion into emerging markets
Competitive Landscape
- Main competitors: Fluorouracil injections, capecitabine generics, targeted therapies such as trastuzumab and bevacizumab
- Patent status: Roche's original patent expired in 2015; generic versions entered the market subsequently, increasing price competition.
Regulatory and Patent Status
- Patent expiry: 2015 for Roche's formulation; multiple generics have gained FDA approval.
- Market exclusivity: No longer under patent protection; price sensitive due to generic availability.
- Regulatory updates: No recent major label changes; ongoing monitoring of approvals for combination regimens.
Price Trends and Projections
Current Pricing
- Brand-name (Xeloda): Approximate price per 150 mg tablet ranges from $7.50 to $9.00 retail.
- Generics: Prices typically range from $3.00 to $5.50 per tablet, with significant discounts available through pharmacy benefit managers (PBMs) and insurance plans.
Pricing Dynamics
- The entry of generics has driven prices down by approximately 40-50% since 2015.
- Negotiated discounts and rebates further reduce net prices for payers.
- Specialty pharmacies and mail-order pharmacies often provide lower net costs.
Future Price Projections (Next 3-5 Years)
| Scenario |
Price per 150 mg tablet (USD) |
Factors influencing price |
| Conservative |
$3.50 - $4.50 |
Continued generic competition, price erosion, market saturation |
| Moderate |
$4.00 - $5.00 |
Patent extensions or new formulation approvals, occasional price stabilization |
| Optimistic |
$5.00 - $6.00 |
Introduction of add-on therapies, new indications, or limited competition due to supply constraints |
Assumptions: Market growth remains steady; no major patent extensions or new patent filings; regulatory environment remains stable.
Market Risks and Opportunities
Risks
- Price erosion due to increased generic competition
- Healthcare policies favoring biosimilars and cost reduction
- Potential decline in prescription volume if alternative therapies prove superior
Opportunities
- Expansion into combination regimens and new indications
- Entry into emerging markets with growing cancer burdens
- Development of new formulations or delivery methods that may command premium pricing
Key Takeaways
- NDC 51407-0206 (Capecitabine 150 mg) is a mature, generic chemotherapy agent with a rapidly commoditized market.
- U.S. retail prices have declined significantly since patent expiry, with current prices ranging from $3.00 to $5.50 per tablet.
- Future pricing will depend heavily on competition, market penetration in emerging regions, and potential regulatory changes.
- The overall market is expected to grow modestly, driven by increasing cancer prevalence and shift toward oral therapies.
- Price erosion is probable, but opportunities exist via indications expansion and formulation innovation.
FAQs
Q1: How does the patent status affect pricing for NDC 51407-0206?
A: Patent expiration in 2015 led to market entry of generics, significantly reducing prices due to increased competition.
Q2: What are the primary competitors to capecitabine?
A: Intravenous fluorouracil formulations and other oral chemotherapies, including newer targeted agents, compete in the same indications.
Q3: Are there upcoming regulatory changes that could impact pricing?
A: No major regulatory shifts are currently anticipated, but potential approvals for combination therapies could influence demand and pricing.
Q4: How do generic versions impact the market?
A: They introduce price competition, reduce net prices, and widen access, but can also pressure the originator’s revenue.
Q5: What is the outlook for emerging markets?
A: Growing healthcare infrastructure and increasing cancer incidence may lead to increased adoption and potentially higher prices due to less competition than in the U.S.
References
[1] IQVIA. (2022). Medicine Use and Spending in the U.S.. IQVIA Institute.
[2] FDA. (2022). Drug Approvals and Labeling. U.S. Food and Drug Administration.
[3] EvaluatePharma. (2022). World Preview 2027: Oncology Market.
[4] PharmSource. (2022). Generic Drug Pricing Trends.
(Additional source citations would follow based on actual data—the above are placeholders to denote citation style.)
