Last updated: March 13, 2026
What is NDC 43598-0390?
NDC 43598-0390 corresponds to Xyosted (tesamorelin), a synthetic growth hormone-releasing hormone analog indicated for the reduction of excess abdominal fat in patients with HIV-associated lipodystrophy. Approved by the FDA in 2017, Xyosted delivers a specialized treatment for a niche patient group.
Market Size and Adoption
Target Population
- HIV-associated lipodystrophy affects approximately 30-50% of HIV-positive patients on antiretroviral therapy.
- Estimated U.S. prevalence: 150,000–250,000 patients (CDC, 2021).
Current Adoption Factors
- Limited to specialist clinics (infectious disease, endocrinology).
- Off-label use negligible.
- Prescriptions peaked at approximately 15,000–20,000 units annually in the U.S. (IQVIA, 2022).
Competitive Landscape
- Primary competitor: Off-label use of growth hormone and other lipodystrophy treatments.
- No direct generics due to patent exclusivity, which lasts until late 2027.
- Patent filings indicate potential for expanded indications, but regulatory hurdles limit near-term growth.
Pricing Analysis
Current Price Points
- Average wholesale price (AWP) for Xyosted is approximately $5,000 – $6,000 per month (Red Book, 2023).
- Typical treatment course: one injection per day, cost totaling $60,000 – $72,000 annually.
Price Comparison
| Product |
Indication |
Wholesale Price |
Cost per Year |
Notes |
| Xyosted (tesamorelin) |
HIV-associated lipodystrophy |
$5,500/month |
$66,000 |
Patent protected, branded |
| Off-label GH use |
Lipodystrophy, other uses |
N/A |
Varies widely |
Often compounded, varying costs |
| Generic GH |
Growth hormone deficiencies |
$2,000 – $4,000/month |
$24,000 – $48,000 |
Off-label, less approved |
Price Trends and Projections
- Patent expiry in late 2027 could pave the way for generics, potentially reducing price by 50-70%.
- Manufacturer strategic pricing may sustain current prices until competition intensifies.
- Pending expansion of indications and seasonal demand fluctuations may influence future prices.
Market Growth and Revenue Projections
Factors Affecting Growth
- Market penetration remains low due to limited awareness and referral pathways.
- Clinical guidelines currently recommend Xyosted primarily for HIV lipodystrophy, constraining broader use.
- New evidence and potential label expansion could increase the treatable population.
Revenue Forecast (2023–2028)
| Year |
Estimated Units Sold |
Revenue (USD millions) |
Assumptions |
| 2023 |
15,000 |
80 |
Baseline with stagnant growth |
| 2024 |
18,000 |
95 |
Slight increase with physician education efforts |
| 2025 |
22,000 |
110 |
Slight expansion to broader markets |
| 2026 |
25,000 |
125 |
Anticipated label expansion, minor price pressure |
| 2027 |
28,000 |
150 |
Approaching patent expiry, price competition starts |
Revenue Sensitivity
- Price reductions could reduce revenue by 30% upon generic entry.
- Market expansion driven by clinical trial data can offset price declines.
Regulatory and Policy Outlook
- FDA approval process remains restrictive for new indications.
- Patent protections prevent generics until late 2027.
- Healthcare payers likely to scrutinize high-cost treatments, influencing formulary inclusion.
Key Takeaways
- NDC 43598-0390 (Xyosted) operates in a niche market with limited competition until late 2027.
- Current annual treatment costs range from $60,000 to $72,000.
- Market size remains constrained, but expansion depends on awareness and label expansion.
- Price reductions are likely in anticipation of generics post-2027, though initial pricing could maintain stability until then.
- Revenue projections indicate growth potential until patent expiry, followed by price erosion and increased competition.
FAQs
1. When will generic versions of Xyosted likely enter the market?
Late 2027, when the patent protection expires.
2. How does Xyosted compare cost-wise to off-label growth hormone treatments?
Xyosted averages $5,500/month; off-label GH treatments vary from $2,000 to $4,000/month, but are less targeted, with less regulatory oversight.
3. What factors could accelerate market growth?
Expanded labeling beyond HIV lipodystrophy, increased provider awareness, and positive clinical trial outcomes.
4. Will price reductions occur before patent expiry?
Not expected significantly until biosimilar or generic competitors enter, starting late 2027.
5. What regulatory hurdles might limit broader use?
FDA approval for additional indications faces a slow process; off-label use remains unregulated but limited by insurer policies.
References
[1] CDC. (2021). HIV Surveillance Report. Centers for Disease Control and Prevention.
[2] IQVIA. (2022). National Prescription Audit.
[3] Red Book. (2023). Prices and Pricing Trends.
[4] FDA. (2017). Approval Letter for Xyosted.
[5] Patent and Trademark Office. (2023). Patent expiry data.
