Last updated: February 27, 2026
What Is NDC 69367-0314?
NDC 69367-0314 identifies a specific drug product within the National Drug Code system. Based on available data, this NDC corresponds to Givosiran (Givlaari), used for the treatment of acute hepaticporphyria (AHP), including variegate porphyria and acute intermittent porphyria.
Market Overview
Market Size and Demand
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Prevalence: AHP is a rare genetic disorder with an estimated prevalence of 1 in 100,000 to 200,000. Calculations suggest approximately 1,000–2,000 patients in the U.S.
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Patient Population: Givosiran is indicated for adults; pediatric use is under investigation but not approved.
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Market Penetration: As a treat-to-symptom control drug, Givosiran’s adoption depends on diagnosis rates, insurance coverage, and physician familiarity.
Key Competitors
- Hemin (Panhematin): Traditional therapy; administered intravenously.
- Lumasiran: Approved for primary hyperoxaluria but not for AHP.
- Supportive care: Symptomatic management with variable efficacy.
Regulatory Status
- FDA Approval: Received in November 2019.
- EMA Status: Approved in Europe under the name Givlaari, with similar indications.
Distribution Channels
- Specialty pharmacies dominate distribution.
- Insurance and government programs influence reimbursement.
Price Analysis
Historical Pricing
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Market Launch Price (2019): Approximate wholesale acquisition cost (WAC) was set at around $555,000 annually per patient.
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Current Pricing: Slight adjustments have been made due to market dynamics and negotiations; actual prices range from $530,000 to $560,000 per year.
Pricing Factors
- High cost driven by R&D recovery, rarity, and manufacturing complexity.
- Payers demand discounts, which can reduce net prices by 10–20%.
Price Projections (Next 3-5 Years)
| Year |
Estimated WAC per Patient |
Key Influencers |
| 2023 |
$540,000 – $560,000 |
Price stabilization, payer negotiations |
| 2024 |
$530,000 – $550,000 |
Broader adoption, potential generic or biosimilar development |
| 2025 |
$520,000 – $540,000 |
Increased competition, reimbursement pressure |
| 2026 |
$520,000 |
Market maturity, volume growth limits |
Key Drivers of Price Movement
- Market penetration: Growing diagnosis rates and expanded indications could raise volume but exert downward pressure on unit price.
- Reimbursement policies: Favorable negotiations could sustain high prices; payers continue to scrutinize drug costs.
- Biosimilars & Generics: No biosimilars currently exist; entry could significantly reduce prices but remains unlikely before 2028.
Future Market Trends
- R&D pipelines: Novel therapies targeting gene editing or RNA interference could challenge Givosiran’s market share.
- Pricing pressure: Healthcare reforms push for price reductions, particularly in Europe and targeted U.S. policy initiatives.
- Market expansion: Expansion into pediatric or broader indications may influence sales volume.
Summary of Key Data Points
| Attribute |
Data Point |
| Approved indications |
Acute hepatic porphyria |
| Launch year |
2019 |
| Initial price (approx.) |
$555,000/year |
| Estimated current price range |
$530,000 – $560,000/year |
| Market size |
~1,000–2,000 U.S. patients |
| Competitive landscape |
Hemin, emerging biosimilars |
| Forecasted price (2026) |
$520,000 – $540,000 |
Key Takeaways
- NDC 69367-0314 (Givosiran) is a high-cost, niche therapeutic for acute hepatic porphyria.
- Market demand remains constrained by disease prevalence, yet demand intensity sustains high prices.
- Price projections indicate slight declines driven by payer negotiations, market expansion, and competition.
- The introduction of biosimilars could significantly impact pricing, expected post-2028.
- Growth will depend more on diagnosis rates and reimbursement strategies than on unit price changes.
Frequently Asked Questions
What is the primary driver behind Givosiran’s high price?
Manufacturing complexity, small patient population, and R&D costs contribute to the high price.
How might biosimilars influence Givosiran’s market?
Biosimilars could reduce prices by 20% or more once introduced, likely after 2028.
What are the main competitors to Givosiran?
Hemin (Panhematin) remains the main alternative; newer RNA-based therapies may emerge.
How does the disease prevalence affect market size?
Limited patient populations restrict total market size, making volume growth crucial for revenue.
What policies could impact future pricing?
Reimbursement reforms, drug price negotiation laws, and cost-containment initiatives in both the U.S. and Europe.
References
- Food and Drug Administration. (2019). FDA approves givosiran for genetic disorder. https://www.fda.gov
- European Medicines Agency. (2021). Givlaari approval details. https://www.ema.europa.eu
- IQVIA. (2022). Biopharmaceutical market forecast. https://www.iqvia.com
- American Porphyria Foundation. (2020). Disease prevalence and management. https://www.porphyria.org
