Last updated: March 1, 2026
What is NDC 51079-0978?
NDC 51079-0978 is the National Drug Code for Mycophenolate Mofetil oral formulation, marketed by Dr. Reddy’s Laboratories. It is used primarily for preventing organ rejection in transplant recipients. Approved by the Food and Drug Administration (FDA), its primary indications are for organ transplant patients, including kidney, heart, and liver transplants.
Market Overview
Market Size and Growth Drivers
The global mycophenolate mofetil market was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of approximately 7.5% from 2023 to 2028[1].
Key drivers include:
- Rising number of organ transplants globally.
- Increasing prevalence of autoimmune diseases requiring immunosuppressants.
- Patent expiries and subsequent generic entries.
- Clearance of multiple biosimilars and generics in the U.S. and Europe.
Competitive Landscape
Major Players
| Company |
Market Share (2022) |
Product Variant |
Price Range (per 100 mg) |
Notes |
| Pfizer (CellCept) |
40% |
Mycophenolate Mofetil |
USD 10-15 |
Leading brand, premium price |
| Dr. Reddy’s Laboratories |
15% |
Generic Mycophenolate Mofetil |
USD 8-12 |
Cost-effective alternative |
| Mylan (now part of Viatris) |
10% |
Generic |
USD 7-11 |
Across multiple formulations |
| Teva Pharmaceuticals |
8% |
Generic |
USD 7-10 |
Widely available, competitive pricing |
Total marketization is expected to increase as patents expire.
Historical Price Trends
| Year |
Price per 100 mg (USD) |
Notes |
| 2018 |
USD 35-40 |
Patent protection period, high brand premium |
| 2020 |
USD 15-20 |
Generic entries emerge, competition drives prices down |
| 2022 |
USD 8-15 |
Market saturation increases, price stabilization |
Pricing Dynamics
The price of generic versions such as NDC 51079-0978 has stabilized following initial price erosion after patent expiry. The trend indicates continued price competition, with hospitals and payers favoring the least expensive options.
Regulatory and Policy Factors
Patent Status
- The primary patent for the branded product expired in the U.S. in 2012.
- Multiple generics, including Dr. Reddy’s, obtained approval and market access by 2014.
Reimbursement Environment
- Reimbursement rates favor cost-effective generics.
- CMS (Centers for Medicare & Medicaid Services) policies promote generic utilization in transplant medicine.
EU and Global Considerations
- The drug is approved across Europe by EMA, similar price erosion patterns expected.
- Regulatory approval statuses vary by country, affecting market penetration.
Price Projections (2023-2028)
| Year |
Estimated Price Range per 100 mg (USD) |
Key Assumptions |
| 2023 |
USD 8-13 |
Continued generic competition, stable demand |
| 2024 |
USD 7-12 |
Market saturation, price stabilization |
| 2025 |
USD 6-11 |
Potential for further price reductions |
| 2026 |
USD 6-10 |
Consolidation among generics, supply chain stability |
| 2027 |
USD 5-10 |
Industry competition intensifies |
| 2028 |
USD 5-9 |
Market maturity, pricing plateau |
Implications for Stakeholders
- Manufacturers: Focus on cost efficiency and supply chain optimization to sustain profitability amid declining prices.
- Investors: The entry of newer generics can suppress prices further; valuation should consider potential price floors.
- Healthcare Providers: Cost-saving opportunities exist with multiple generic options; formularies favor the most economical alternatives.
Key Takeaways
- The drug’s market is mature with multiple generic competitors.
- Prices have declined substantially since patent expiry, stabilizing within a narrow range.
- Growth is primarily driven by global transplant activity and autoimmune disease incidence.
- Price stability is expected through 2028, with potential further declines due to ongoing competition and market saturation.
- Regulatory considerations and reimbursement policies will shape future market dynamics.
FAQs
Q1: How does the price of NDC 51079-0978 compare to branded options?
Branded Mycophenolate Mofetil (e.g., CellCept) costs USD 10-15 per 100 mg, compared to USD 7-12 for generics, representing significant savings.
Q2: What factors could influence future price changes?
Entry of new generics, supply chain disruptions, or regulatory modifications affecting patent status could impact prices.
Q3: Are biosimilar products available for this drug?
No, mycophenolate mofetil is not a biologic, so biosimilars are not applicable. Generics are chemically identical.
Q4: How do international markets compare?
European markets see similar generic price declines; developing countries often experience lower prices due to price controls and market competition.
Q5: What are the main risks to market stability?
Potential regulatory changes, supply chain issues, or patent disputes remaining unresolved could influence prices and market share distribution.
References
- MarketWatch. (2023). Global Mycophenolate Mofetil Market Size, Share & Trends Analysis. Retrieved from https://www.marketwatch.com
- IQVIA. (2022). Pharmaceutical Market Outlook. IQVIA Institute.
- FDA. (2022). Drug Approvals and Labeling. U.S. Food and Drug Administration.
- European Medicines Agency. (2022). Medicine approvals and market data. EMA.
