Last updated: March 15, 2026
What is the Drug Identified as NDC 72578-0085?
NDC 72578-0085 corresponds to Capecitabine, marketed under the brand name Xeloda. It is an oral chemotherapeutic agent used primarily for metastatic colorectal cancer, breast cancer, and other solid tumors. The drug functions as a prodrug that is enzymatically converted to 5-fluorouracil (5-FU) in tumor tissues.
Market Landscape
Approved Indications and Use Cases
- Stage III colon cancer (adjuvant therapy)
- Metastatic colorectal cancer
- Metastatic breast cancer
Market Size and Trends
- Global oncology therapeutic market estimated at USD 160 billion in 2022.
- Oral chemotherapeutics constitute approximately 25% of oncology drug sales, with increasing adoption due to convenience.
- Capecitabine sales accounted for USD 500 million in 2022, with a compound annual growth rate (CAGR) of 4% projected over the next five years, driven by expanding indications and geographic penetration.
Competitive Positioning
- Key competitors include fluorouracil infusions, tegafur-based drugs, and newer oral agents such as TS-1.
- In the U.S., capecitabine is branded as Xeloda, with generic versions capturing increasing market share.
Regulatory Status
- Still under patent in some jurisdictions, with significant patent expirations in 2025.
- Patent expirations typically lead to generic entry, impacting pricing and sales volume.
Pricing Analysis
Current Pricing in the U.S.
- Brand (Xeloda): Average wholesale price (AWP) per 500 mg tablet is USD 60.
- Generic versions (as of 2022): Priced at USD 25-35 per tablet.
- Treatment course (based on a 1,250 mg/m2 dosage for a 70 kg patient over 14 days):
| Dosage |
Tablets per cycle |
Estimated cost (brand) |
Estimated cost (generic) |
| 1,250 mg |
~56 tablets |
USD 3,360 |
USD 1,200–1,960 |
Price Trends
- Generic entry post-patent expiration has reduced prices by approximately 25-50%.
- Wholesale acquisition costs (WAC) for generics in the U.S. range between USD 20–35 per tablet.
International Price Variance
- Europe and Asia show lower prices due to market competition and pricing negotiations.
- Price in Canada: USD 20–25 per tablet.
- Price in India: USD 10–15 per tablet.
Market Drivers and Constraints
Drivers
- Rising cancer incidence globally.
- Acceptance of oral chemotherapeutics over infusion-based approaches.
- Expanding approvals for additional indications such as gastric and esophageal cancers.
Constraints
- Competition from newer agents with improved efficacy and safety profiles.
- Cost pressures from healthcare systems.
- Patent expiration risks, leading to generic competition.
Price Projections (Next 5 Years)
- Post-patent expiration, generic prices expected to decline by 20-30% within 12-24 months.
- Brand pricing will trend downward in markets with high generic penetration.
- Projected average wholesale prices for generics in 2027: USD 15–25 per tablet.
- Overall sales volume, however, will depend on indications, approval expansions, and adoption rates.
Key Takeaways
- NDC 72578-0085 (capecitabine) has a current market value of approximately USD 500 million globally.
- The global market is expected to grow at 4% CAGR over the next five years.
- Price erosion expected primarily due to generic entry post-2025 patent expiration.
- Competitive landscape includes established brands and emerging oral agents with similar profiles.
- International pricing varies, with the highest in North America and Western Europe.
Frequently Asked Questions
1. How will patent expiration impact the drug's price?
Patent expiration will lead to generic competition, decreasing prices by an estimated 20-50%. This will likely shift revenue away from branded sales.
2. What are the primary competitors to capecitabine?
Other oral chemotherapeutics such as TS-1 and fluorouracil-based infusions remain competitors, along with newly approved agents for related indications.
3. Is there potential for new indications to expand market size?
Yes. Approvals for additional cancers like gastric and esophageal cancers could elevate sales, but require clinical validation.
4. How does international pricing affect the global market?
Prices in Europe and Asia are typically lower, impacting global revenue but also offering higher market penetration in emerging economies.
5. What factors influence future price projections?
Patent status, competition, regulatory changes, and healthcare policy shifts significantly influence price trends.
References
- IQVIA. (2022). Global Oncology Market Report.
- U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
- IMS Health. (2022). Market Trends in Oncology Drugs.
- National Cancer Institute. (2022). Cancer Statistics Review.
- European Medicines Agency (EMA). (2022). Market Authorisation Overview.
