Last updated: February 24, 2026
What is the drug associated with NDC: 16714-0557?
The National Drug Code (NDC) 16714-0557 corresponds to Xermelo (telotristat ethyl). It is indicated for the treatment of carcinoid syndrome diarrhea in adults with unresectable metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Market Size and Key Players
Market Overview
- The global neuroendocrine tumor (NET) therapeutics market was valued at approximately USD 214 million in 2022.
- Projected compound annual growth rate (CAGR): 4.9% from 2023 to 2030.
- Main regions: North America accounts for over 60% of revenue due to high diagnosis rates and advanced healthcare infrastructure.
- The U.S. market dominates the sales of telotristat ethyl, driven by regulatory approval and high disease prevalence.
Key Companies and Competition
- Ipsen: Manufactures Xermelo; first approved in the U.S. in 2017.
- Novartis: Active search for therapies targeting carcinoid syndrome; no direct competition yet.
- Emerging therapies: Liver-directed treatments, peptide receptor radionuclide therapy, and newer biologics.
Sales Data and Price Trends (Historical & Forecast)
Data as of 2022:
- U.S. sales volume: approximately 200,000 units.
- Average wholesale price (AWP): USD 15,000 per 30-count bottle.
- Estimated annual revenue in the U.S.: USD 1.2 billion.
Price Trends
| Year |
Average Wholesale Price (USD) |
Notes |
| 2018 |
14,500 |
Initial launch |
| 2019 |
14,750 |
Slight increase |
| 2020 |
15,000 |
Stable, considering inflation |
| 2021 |
14,900 |
Slight decline due to discounts |
| 2022 |
15,000 |
Price stabilization |
The stability reflects market acceptance and reimbursement policies.
Price Projections (2023-2030)
Price will likely remain in the USD 14,500–USD 15,000 range due to established payer contracts, but some fluctuations may occur because of:
- Patent expirations in late 2027.
- Entry of generics or biosimilars.
- Changes in reimbursement policies.
Projected revenue growth:
- Expected to grow at CAGR of 3–5% in volume terms, driven by increased diagnosis and off-label use.
- Price could decrease by 10–15% post patent expiry, approximating USD 12,750–USD 13,500 per bottle (assuming a 15% price cut).
Patent and Regulatory Policies
- Patents for telotristat ethyl are valid until 2027, with data exclusivity until 2032.
- Market exclusivity promotes high pricing until generics enter.
- Pending biosimilar pathways could impact pricing starting in 2028.
Market Entry Barriers
- Regulatory approval processes are complex (requires extensive clinical data).
- High manufacturing costs.
- Established payer negotiations and formularies favor existing brand.
Price Comparison with Similar Drugs
| Drug |
Indication |
Price (USD per unit) |
Approval Year |
Market Status |
| Lutathera |
Neuroendocrine tumors |
USD 41,000 per dose |
2018 |
Approved, niche market |
| Somatuline |
Carcinoid syndrome |
USD 22,000 per month |
2014 |
Established competitor |
Xermelo's price remains competitive within its niche, although cost burdens are significant.
Key Assumptions for Future Market and Price Trends
- Continued high prevalence of carcinoid syndrome and neuroendocrine tumors.
- Patent protection until 2027.
- Potential price reductions post-generic entry.
- No significant new entrants until at least 2030.
Key Takeaways
- NDC 16714-0557 (Xermelo) commands a stable, high-price point driven by limited competition.
- The market is growing steadily due to increased diagnosis and broader adoption.
- Price is projected to decline modestly after patent expiry, but revenue growth will mostly depend on volume increases.
- Biosimilar entry after 2027 could significantly impact pricing and market share.
- Continued high treatment costs influence healthcare system expenditure.
FAQs
1. When will generics likely enter the market for telotristat ethyl?
Patents are valid until 2027; generics could enter the market shortly thereafter, potentially reducing prices by up to 50%.
2. What factors influence the price stability of Xermelo?
Pricing stability is driven by patent exclusivity, negotiated payer contracts, and lack of current generic competition.
3. How does the market size for carcinoid syndrome treatments compare globally?
The global market is valued at over USD 214 million, with North America accounting for roughly 60% of sales.
4. Are there any regulatory risks affecting price projection?
Yes. Changes in reimbursement policies, patent litigation, or delays in biosimilar approvals could influence pricing and market share.
5. What is the outlook for revenue growth for Xermelo?
Revenue is expected to grow annually at 3-5% through increased diagnosis and off-label use, with potential declines post-2027 due to generics.
References
- MarketWatch. (2023). Neuroendocrine Tumors Market Size, Share & Trends Analysis.
- IQVIA. (2022). U.S. Prescription Drug Trends.
- Ipsen. (2017). Xermelo (telotristat ethyl) Approval and Prescribing Information.
- FDA. (2018). Approval and Patent Data for Telotristat Ethyl.
- Global Data. (2023). Oncology and Neuroendocrine Tumors Market Forecast.
