Last updated: March 1, 2026
What is the Status of the Drug Identified as NDC: 16571-0111?
The drug with the National Drug Code (NDC) 16571-0111 is Ivacaftor, marketed under the brand name Kalydeco by Vertex Pharmaceuticals. Approved by the FDA in 2012, Ivacaftor treats cystic fibrosis in patients with specific gating mutations, such as G551D.
Market Size and Patient Demographics
- Cystic Fibrosis Prevalence: Approximately 33,000 patients in the U.S. have cystic fibrosis.
- Gating Mutation Prevalence: About 4-5% of cystic fibrosis patients carry the G551D mutation.
- Eligible Population: Estimated 1,500 to 2,000 U.S. patients qualify for Ivacaftor based on mutation-specific approval.
Sales and Revenue Data
Vertex Pharmaceuticals reported:
- 2019: $1.38 billion in U.S. sales for Ivacaftor and its combination therapies.
- 2020: $2.41 billion globally, with approximately 73% generated in the U.S.
- 2021: Revenue increased to $2.88 billion, indicating strong market demand.
Price Projections
Current Pricing (List Price)
- Monthly Cost: Approximately $30,000 per patient, or around $360,000 annually.
- Pricing Elements:
- List prices are often discounted publicly by payers; net prices may vary.
- Insurers apply negotiated discounts and rebates, reducing the actual cost burden.
Future Price Trends
- Price Stability: No significant planned reductions; high treatment costs are rooted in the drug’s orphan drug status and limited patient pool.
- Potential for Increase: Introduction of new formulations or combinations may lead to price adjustments.
- Market Dynamics: Patent protections extend into the late 2020s, delaying generics. However, biosimilars or alternative therapies could pressure pricing in the next decade.
Competitive Landscape and Impact on Price
- Combination Therapies: Lumacaftor/Ivacaftor (Orkambi), Tezacaftor/Ivacaftor (Symdeko), and Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) have captured larger market shares.
- Market Share: Trikafta, approved in 2019, dominates the market with a broader mutation profile, reducing Ivacaftor-alone sales.
- Price Differentiation: Trikafta’s wholesale price is around $311,000 annually, but combination therapies command higher list prices.
Price Projection Model
| Year |
Estimated Annual Cost per Patient |
Key Influencers |
Market Penetration Factors |
| 2023 |
$360,000 |
Patent protections, high demand |
Limited competition, mutation-specific prescribing |
| 2025 |
$365,000 |
No significant biosimilar threat, inflation |
Market saturation, payer negotiations |
| 2030 |
$370,000 |
Possible biosimilar entry, typical inflation (~1-2%) |
Patent expiry considerations, new FDA approvals |
Key Market Drivers and Risks
Drivers
- Continued reliance on mutation-specific therapies.
- Increasing diagnosis rates due to newborn screening.
- Expansion of indications with ongoing clinical trials.
Risks
- Patent expirations could lead to generic or biosimilar competition.
- Pricing pressure from payers seeking rebates and discounts.
- Development of alternative therapies with broader efficacy.
Regulatory and Policy Environment
- Orphan drug exclusivity extends until approximately 2032.
- Policies favoring biosimilar entry could influence future pricing.
- Payer negotiations are increasingly aggressive due to high drug costs.
Summary
Ivacaftor (NDC: 16571-0111) remains a high-cost, mutation-specific therapy for cystic fibrosis. Its annual price is approximately $360,000 per patient, with limited downward pressure due to patent protections and market exclusivity. The emergence of combination therapies and biosimilars may impact pricing in the next decade, but current projections suggest stable or slight increases aligned with inflation.
Key Takeaways
- The drug targets a small, mutation-specific patient subset, limiting market size.
- Sales have consistently increased, with revenue reaching nearly $3 billion globally in 2021.
- Price stability is expected through at least 2025, with modest growth aligned with inflation.
- Patent protections and high demand sustain current pricing levels.
- Competition from combination therapies and biosimilars could influence future pricing trends.
FAQs
-
What is the primary indication for Ivacaftor?
Treatment of cystic fibrosis in patients with specific gating mutations.
-
When do patent protections for Ivacaftor expire?
Patent protections extend until approximately 2032.
-
How does Ivacaftor compare in price to combination therapies?
Ivacaftor-alone costs around $360,000 annually; combination therapies like Trikafta are priced higher, approximately $311,000, but cover broader patient populations.
-
What factors could lower the drug’s future price?
Biosimilar entry, generic alternatives, or significant policy changes.
-
Is demand for Ivacaftor expected to grow?
Yes, demand is supported by increased cystic fibrosis diagnoses and expanded indications.
References
[1] Vertex Pharmaceuticals. (2022). Annual Reports.
[2] FDA. (2012). Approval of Ivacaftor.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] Medicare & Medicaid Policies. (2023). Orphan Drug Pricing.
[5] WHO. (2020). Cystic Fibrosis Prevalence Studies.
