Last updated: February 24, 2026
What is NDC 49884-0158?
NDC 49884-0158 refers to a specific drug product, which appears to be Episil. Episil is a topical gel used to manage oral mucositis pain in cancer patients. It is marketed by Sorrento Therapeutics Inc. However, access to precise regulatory details and market data is limited, given proprietary and confidential status.
Market Landscape
Indication and Target Population
- Indication: Pain relief for oral mucositis in chemotherapy or radiation therapy patients.
- Target Population: Primarily adult cancer patients undergoing treatment with a high incidence of oral mucositis, which ranges from 40-80%, depending on therapy intensity (source [1]).
Competitive Environment
Regulatory and Reimbursement Status
- FDA Approval: Approved in the U.S. for oral mucositis pain relief.
- Reimbursement: Covered through insurance plans, but reimbursement thresholds and coverage policies vary by payer, impacting market penetration.
Sales Data and Market Penetration
- Estimated Sales: Sorrento’s reported revenues from Episil in recent years suggest low to moderate sales, roughly in the tens of millions USD annually, indicating limited adoption.
- Market Penetration: Slow adoption due to competition, physician preference for other agents, and limited awareness.
Price Projections
Current Pricing
- Average Wholesale Price (AWP): Estimated at around $250–$350 per 30 mL application (source [2]). Price varies based on purchase volume and insurance coverage.
Pricing Trends and Future Projections
Factors Influencing Price Dynamics
| Factor |
Impact |
| Competition from generics |
Downward pressure on price |
| Market expansion |
Possible price increase if new indications approved |
| Reimbursement policies |
Influences willingness to pay, can sustain or reduce prices |
| Manufacturing costs |
Affect profit margins, indirectly affecting pricing |
Market Projections Summary
| Year |
Estimated Market Value (USD millions) |
Price per unit (USD) |
Notes |
| 2023 |
20–30 |
250–350 |
Current sales, slow growth |
| 2024 |
22–33 |
240–340 |
Minor price decrease, increased adoption |
| 2025 |
25–40 |
230–330 |
Market expansion, new clinical data |
Note: These estimates are speculative, based on current sales and market trends.
Key Market Drivers and Risks
Drivers
- Growing prevalence of oral mucositis in cancer therapy.
- Increasing use of targeted and immunotherapies that cause mucositis.
- Growth in reimbursement coverage for supportive care drugs.
Risks
- Entry of inexpensive or more effective alternatives.
- Regulatory delays or restrictions.
- Physician preference for existing standard-of-care therapies.
Key Takeaways
- NDC 49884-0158 (Episil) occupies a niche for pain relief in oral mucositis, with modest market penetration.
- Current pricing averages roughly $250–$350 per application, with potential for modest declines due to competition.
- Market growth depends heavily on increased adoption, expanded indications, and clinical acceptance.
- Competitive landscape is dominated by a few approved agents, limiting rapid expansion.
- Long-term pricing trajectories depend on regulatory developments, competition, and insurance reimbursement policies.
FAQs
1. How does Episil compare to other oral mucositis treatments in efficacy?
Episil provides symptom relief primarily through topical application; its efficacy depends on patient adherence and severity of mucositis. It has been shown to reduce pain but not prevent mucositis onset.
2. What factors could significantly impact the market for NDC 49884-0158?
Approval of new drugs, growth in mucositis prevalence, insurance reimbursement policies, and clinical guideline updates.
3. Are there developments that could lead to price increases?
Yes. Approval of additional indications or formulations, improved clinical outcomes, or branded product differentiation may support higher prices.
4. What is the approximate total addressable market size?
Estimated at hundreds of thousands of patients annually in the US alone, considering the incidence of oral mucositis in cancer therapy and treatment of supportive care drugs.
5. How does the competitive landscape affect future prospects?
High competition from other approved agents and generics pressures prices downward; significant market share gains require differentiated efficacy or broader indications.
References
[1] Sonis, S. T. (2011). Oral mucositis. Gerodontology, 28(1), 59-65.
[2] Sorrento Therapeutics Inc. (2021). Annual Report. Retrieved from https://investors.sorrento.com
