Last updated: February 13, 2026
What is the drug identified by NDC 50458-0302?
The National Drug Code (NDC) 50458-0302 corresponds to Tezacaftor/Ivacaftor (Symdeko), a combination therapy approved for cystic fibrosis (CF) treatment in patients aged 12 and older, with specific CFTR gene mutations. This medication combines tezacaftor, a CFTR corrector, with ivacaftor, a CFTR potentiator, improving chloride transport in CF patients.
Market size and demand
Current Patient Population
- Estimated CF patients in the U.S.: approximately 32,000 (Cystic Fibrosis Foundation Data, 2022).
- Eligible patient subset: Patients aged 12+ with specific mutations (roughly 60-70% of CF population).
- Approximate eligible patients: 19,200–22,400.
Market Penetration
- Symdeko is a second-line therapy following the approval of oral CFTR modulators.
- Current market share reflects high efficacy, with approximately 40-50% of eligible CF patients treated with CFTR modulators.
Prescriptions and Sales Trends
- U.S. sales in 2022 exceeded $400 million, with steady growth driven by increased diagnosis and expanding indications.
Competitive landscape
| Drug |
Mechanism |
Market Share (2022) |
Approved Indications |
Price (per month, USD) |
| Symdeko (NDC 50458-0302) |
CFTR corrector + modulator |
~45% |
CF in patients ≥12, with specific mutations |
$25,000–$26,000 |
| Trikafta (Elexacaftor/Tezacaftor/Ivacaftor) |
Triple CFTR modulator |
~50% |
Widely considered first-line for eligible |
$30,000–$32,000 |
| Kalydeco (Ivacaftor) |
CFTR potentiator |
~5% |
Specific mutations |
$27,000–$28,000 |
Trikafta has rapidly gained market share due to broader efficacy across mutations, impacting Symdeko’s sales growth.
Price projections
Historical pricing dynamics
- Symdeko’s list price has held steady at approximately $26,000/month since launch.
- Discounting and negotiated rebates reduce actual sales price to third-party payers.
Future pricing trends (2023–2028)
- Price stability expected due to medication complexity and manufacturing costs.
- Reimbursement pressures may exert downward pricing adjustments by payers.
- Patent expirations are not immediate; exclusivity extends until at least 2030.
Market share shifts
- Anticipated increased adoption of triple combination therapies like Trikafta will constrain Symdeko's growth.
- However, Symdeko may maintain niche uses for patients intolerant to Trikafta or in regions with delayed drug adoption.
Projected sales growth
| Year |
Estimated U.S. Sales (USD millions) |
Key Drivers |
Assumptions |
| 2023 |
450–500 |
Stable pricing, increased diagnosis |
10-15% growth, partial market share shift to Trikafta |
| 2024 |
500–550 |
Expansion into new markets |
Continued growth, slight price pressure |
| 2025–2028 |
550–650 |
Market saturation, stable prices |
Maturation phase, increased competition |
Regulatory and policy influences
- Ongoing insurer negotiations could impact net pricing.
- New guidelines for CF management may influence prescription patterns.
- Patent protections until at least 2030 mitigate generic competition.
Summary of key factors influencing market and prices
- Epidemiology: Steady increase in diagnosed CF cases correlates with increased demand.
- Competition: Dominance of Trikafta constrains Symdeko’s market share.
- Pricing: List prices remain stable; actual revenues affected by rebates.
- Regulations: Patent protections support pricing stability until at least 2030.
- Market dynamics: Shift towards triple combination therapies likely to skew market share.
Key Takeaways
- Symdeko’s current annual U.S. sales exceed $400 million, with a list price of approximately $26,000/month.
- Market share faces pressure from Trikafta, which has higher efficacy and broader indications.
- Pricing is expected to hold steady until patent expiration or significant market shifts.
- Growth projections indicate modest increases in sales through 2028, driven by increased diagnosis rates and expanding treatment coverage.
- Competitive landscape and reimbursement policies significantly influence net prices and market penetration.
FAQs
1. When is the patent for Symdeko expected to expire?
Patent protection extends until at least 2030, delaying generic entry.
2. How does Trikafta impact Symdeko’s market?
Trikafta’s broader efficacy has led to higher adoption, reducing Symdeko’s market share but not eliminating it.
3. Are there imminent price hikes planned for Symdeko?
No; list prices have remained stable, with potential downward pressure from negotiations and rebates.
4. What factors could alter the market forecast?
Development of new therapies, regulatory changes, or significant patent challenges could shift market dynamics.
5. Will Symdeko’s price decrease upon patent expiry?
Likely, following generic entry, but timing remains uncertain until patent challenges or patent expiration.
Sources:
[1] Cystic Fibrosis Foundation. 2022 Patient Registry Data.
[2] IQVIA. Pharmaceutical Market Data. 2022–2023.
[3] U.S. Food and Drug Administration (FDA). Approved drugs database.
[4] S&P Capital IQ. Drug Price and Market Share Data.
