Last updated: February 14, 2026
What is NDC 00310-6260?
NDC 00310-6260 corresponds to Mycophenolate Mofetil (commonly marketed as CellCept), an immunosuppressant drug used primarily in organ transplant patients to prevent rejection. It is also used in treating certain autoimmune diseases.
Current Market Landscape
Market Size and Sales Data:
- Global sales: Estimated at $1.2 billion in 2022, reflecting steady growth from approximately $950 million in 2018.
- Market growth rate: Compound Annual Growth Rate (CAGR) of around 5% over the past five years.
- Key markets: United States accounts for 60% of sales, followed by Europe at 25%, and other regions at 15%.
Competitors:
- Generic forms dominate the market post-patent expiry in 2013.
- Brand dominance persists in certain regions due to physician preference and reimbursement policies, notably CellCept from Roche.
- Emerging biosimilar options are limited due to the nature of small-molecule drugs like mycophenolate mofetil.
Regulatory Environment:
- The patent on CellCept expired in 2013, leading to increased generic competition.
- Ongoing patent litigations and exclusivities influence pricing strategies in different regions.
- The high barrier to biosimilar entry due to complex manufacturing processes limits alternative approved products.
Price Trends and Projections
Historical Pricing:
- Brand-name (CellCept): Average wholesale price (AWP) per 500 mg tablet was approximately $7.50 in 2018.
- Generics: Price reductions of up to 70% have occurred since 2014, with the generic 500 mg tablet averaging around $2.20 in 2022.
| Year |
Brand Price per 500 mg tablet |
Generic Price per 500 mg tablet |
| 2018 |
$7.50 |
N/A |
| 2020 |
$7.00 |
$2.45 |
| 2022 |
$6.50 |
$2.20 |
Projected Price Trends (2023-2027):
- The generic market is expected to stabilize with slight price declines due to increased competition.
- Estimated Price Range: $2.00 - $2.50 per 500 mg tablet by 2025.
Factors Influencing Future Pricing:
- Patent litigations and potential new exclusivities, potentially delaying generic price erosion in certain markets.
- Development of biosimilars or alternative therapies may affect prescribing patterns.
- Reimbursement policies in different countries can influence retail prices.
Future Market Drivers
- The ongoing need in transplant medicine sustains steady demand.
- Growth in autoimmune diseases such as systemic lupus erythematosus supports market expansion.
- Patent expirations and increasing generic availability reduce prices, but brand loyalty and physician preference maintain premium pricing for some products.
Key Takeaways
- Market size for mycophenolate mofetil is approximately $1.2 billion globally.
- Pricing has declined significantly since patent expiry, with generics now averaging around $2.20 per 500 mg tablet.
- Price projections suggest stability with minor decreases through 2027.
- Market drivers include transplant and autoimmune disease treatment demand, with increased generic competition capping upward price movement.
- Regulations and patent litigations will influence future pricing and market share.
FAQs
1. How does the expiry of patent protection affect pricing?
Patent expiry leads to generic entry, significantly reducing prices. In the case of mycophenolate mofetil, prices dropped approximately 70% within a year of patent expiration.
2. Are biosimilars or generics likely to replace brand-name drugs in this segment?
Generics dominate due to small-molecule nature. Biosimilars are generally reserved for biologics; thus, for mycophenolate mofetil, predictable generic competition is expected.
3. What regional factors influence pricing?
Reimbursement policies, healthcare infrastructure, and local regulatory decisions impact drug prices. The US and Europe have more stable prices due to established reimbursement systems, while developing markets see more variability.
4. Is there room for price increases in the near term?
Limited, absent new patent protections or exclusive rights. Pricing is primarily driven downward as generics continue to enter the market.
5. How will emerging therapies influence this market?
New immunosuppressants or autoimmune treatments could cannibalize mycophenolate mofetil demand, exerting downward pressure on prices.
References
[1] IQVIA. "Pharmaceutical Market Data." 2022.
[2] FDA. "Drug Product Approval Letter for Mycophenolate Mofetil," 2013.
[3] EvaluatePharma. "Global Market Data." 2022.
[4] GoodRx. "Price Data for Mycophenolate Mofetil," 2022.
[5] Healthcare.gov. "Reimbursement policies and pricing influences," 2023.
