Last updated: February 21, 2026
What is NDC 42799-0816?
NDC 42799-0816 corresponds to Pomalidomide Capsules 2 mg, marketed by Celgene Corporation (a Bristol Myers Squibb company). It is indicated for multiple myeloma, particularly in patients who have received at least two prior therapies, including bortezomib and lenalidomide.
Market Overview
Current Market Position
- Indication: Multiple myeloma, relapsed/refractory cases.
- Market Size: The global multiple myeloma market was valued at approximately USD 9.2 billion in 2022 (Grand View Research). The relapsed/refractory segment accounts for about 45% of sales.
- Competition: Includes drugs like lenalidomide (Revlimid), pomalidomide (this drug), carfilzomib, and daratumumab.
Key Drivers
- Increasing incidence of multiple myeloma, especially in aging populations.
- Advancements in combination therapies expanding the patient population.
- Patent exclusivity until at least 2027, with potential for extension via patents or new formulations.
- Growing adoption in the U.S., Europe, and emerging markets.
Market Trends
- Shift towards combination regimens involving pomalidomide.
- Rising generic competition expected from biosimilars and small-molecule competitors post-patent expiry.
- Increasing use in earlier lines of therapy, which could impact future sales.
Price Analysis
Current Price Benchmarks
-
Wholesale Acquisition Cost (WAC): Approximately USD 8,400 per 28-count capsule bottle (average of USD 300 per capsule), based on latest available data (as of early 2023).
-
Average Selling Price (ASP) in the U.S.: Estimated around USD 9,500 per bottle, accounting for discounts and rebates.
Pricing Compared to Competitors
| Drug |
Dosage |
Approximate Price (USD) |
Market Position |
| Pomalidomide |
2 mg capsule |
USD 8,400 - USD 9,500 |
Leading agent in relapsed/refractory MM |
| Lenalidomide |
15 mg capsule |
USD 10,000 - USD 11,500 |
More established, broader use |
| Carfilzomib |
60 mg vial |
USD 4,800 per vial |
Alternative, intravenous formulation |
Pricing Trends & Projections
- Historical Price Trend: Prices have remained relatively stable since 2020, with minor fluctuations due to market dynamics and manufacturer negotiations.
- Projection for 2025-2030:
- Base Case: Slight increase of 2-3% annually, driven by inflation, packaging, and label extensions.
- Potential Decrease: Large biosimilar entries and patent cliffs in late 2020s could reduce prices by 20-30% in the U.S.
Regulatory and Patent Landscape
- Patent Expiry: Expected around 2027, with some secondary patents potentially extending exclusivity.
- Biosimilar Entry: Biosimilar versions of pomalidomide are in early development stages, with potential launches post-2027.
- Regulatory Developments: Approval of new formulations (e.g., extended-release) could impact pricing strategies.
Market Forecast and Revenue Potential
Revenue Projections (2023-2030)
| Year |
Estimated Revenue (USD billion) |
Assumptions |
| 2023 |
1.2 |
Stable market share, minor price erosion |
| 2025 |
1.3 |
Increased adoption, minor price hikes |
| 2027 |
1.4 |
Onset of biosimilar competition |
| 2029 |
1.2 |
Biosimilar competition impacts prices |
Key Upside & Downside Risks
- Upside: New combination approvals, expanded indications, sustained market share.
- Downside: Patent expiration, biosimilar competition, tighter reimbursement policies.
Key Takeaways
- NDC 42799-0816, pomalidomide capsules, are a targeted therapy with a sizable existing market.
- The current price aligns with typical segment standards, with a potential for modest increases through 2025.
- Patent expiration around 2027 may lead to significant price reductions due to biosimilar and generic entry.
- Market growth depends on label expansions, combination therapies, and market penetration in emerging regions.
FAQs
1. When does the patent for pomalidomide expire?
Patent protections are expected to expire around 2027, though secondary patents may extend market exclusivity.
2. How will biosimilar competition affect prices?
Biosimilar entry post-2027 could reduce prices by 20-30%, impacting revenue and market share.
3. What are the key indications for NDC 42799-0816?
Primarily used in relapsed/refractory multiple myeloma patients who have received prior therapies.
4. Are there approved combination therapies involving this drug?
Yes. It is used alongside agents like dexamethasone, with ongoing clinical trials exploring other combinations.
5. What emerging markets could influence future sales?
China, India, and Latin America show increasing adoption potential, influenced by regulatory pathways and pricing policies.
References
[1] Grand View Research. Multiple Myeloma Market Size & Share Report, 2022.
[2] U.S. Food and Drug Administration. Drug Approval and Patent Data, 2022.
[3] IQVIA. Pharmaceutical Pricing Database, 2023.
[4] Biosimilar Market Reports, 2022.
[5] Bristol Myers Squibb Corporate Reports, 2022.
