Last updated: February 22, 2026
What is NDC 72336-0112?
NDC 72336-0112 refers to a specific drug product. Based on available databases, this NDC corresponds to Patisiran (Onpattro), an FDA-approved RNA interference (RNAi) therapeutic for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Market Overview
Disease Indication and Market Size
- Hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) is a rare, progressive disease caused by misfolded transthyretin proteins depositing in tissues.
- The global prevalence of hATTR amyloidosis is estimated at approximately 50,000 patients.
- In the U.S., the treated population is roughly 6,000–8,000 patients, reflecting underdiagnosis due to disease complexity.
Competitive Landscape
- Patisiran (Onpattro): First RNAi therapy approved for hATTR amyloidosis.
- Inotersen (Tegsedi): An antisense oligonucleotide, also for hATTR amyloidosis with polyneuropathy.
- Vutrisiran (Amvuttra): A second-generation RNAi therapy, approved in 2022, demonstrating improved dosing and efficacy profiles.
Key Market Factors
- Pricing: In the U.S., Patisiran's list price ranges around $450,000 annually.
- Reimbursement: Managed through insurance, CMS, and specialty pharmacy settings.
- Market Penetration: As the first RNAi therapy, Patisiran has captured a significant portion of eligible patients but faces increasing competition from Vutrisiran.
Price Analysis
Current Pricing
| Drug Name |
Approval Date |
List Price (Annual) |
Notes |
| Patisiran (Onpattro) |
August 2018 |
~$450,000 |
Premier first-in-class RNAi therapy |
| Inotersen (Tegsedi) |
October 2018 |
~$360,000 |
Lower cost alternative |
| Vutrisiran (Amvuttra) |
April 2022 |
~$450,000 |
Improved dosing regimen |
Price Trends
- Patisiran's price has remained stable since launch.
- Vutrisiran's introduction has not significantly altered out-of-pocket costs but has expanded access due to dosing convenience.
- Pricing strategies prioritize recoupment of R&D investments while aligning with reimbursement frameworks for high-cost orphan drugs.
Revenue Projections
Assumptions
- Market Penetration: 20–30% of eligible patients within five years.
- Annual Price: $450,000, with potential adjustments for inflation and rebates.
- Patient Population Growth: Annual increase of 3% due to improved diagnosis and awareness.
Revenue Estimates (Over 5 Years)
| Year |
Estimated Patients |
Revenue (at $450,000) |
Cumulative Revenue |
| 2023 |
1,200 |
$540 million |
|
| 2024 |
1,600 |
$720 million |
|
| 2025 |
2,000 |
$900 million |
|
| 2026 |
2,400 |
$1.08 billion |
|
| 2027 |
2,800 |
$1.26 billion |
|
Adjusted for market expansion and greater diagnosis rates, total cumulative revenue over five years could surpass $4 billion.
Regulatory and Market Risks
- Market Entry of New Therapies: Vutrisiran's approvals and future biosimilar or generic entrants could reduce prices.
- Reimbursement Dynamics: Changes in insurance coverage or reimbursement codes may influence pricing.
- Diagnostic Advances: Improved testing could increase diagnosed patient populations, boosting revenue.
Key Takeaways
- NDC 72336-0112 (Patisiran) has a stable list price around $450,000/year.
- Market size remains limited by the rarity of hATTR amyloidosis but has growth potential with increased diagnosis.
- The introduction of second-generation therapies could stabilize or reduce prices over the next 3–5 years.
- Revenue projections suggest a potential for exceeding $1 billion annually by 2026.
- Competition and reimbursement policies are primary risks affecting long-term pricing strategies.
FAQs
Q1: How does Vutrisiran impact Patisiran's market?
Vutrisiran offers similar efficacy with less frequent dosing, which could reduce Patisiran’s market share and pressure pricing.
Q2: What are the main factors affecting the drug’s price?
Rarity of the condition, high development costs, limited competition, and reimbursement negotiations influence the price stability.
Q3: Are biosimilars likely for Patisiran?
Biosimilar development could emerge within 7–10 years, given RNAi therapy's complex manufacturing and approval pathways.
Q4: How does the dosing frequency affect market adoption?
Less frequent dosing (semiannual or annual) improves patient adherence, possibly increasing market penetration and justifying high pricing.
Q5: What is the potential for international sales?
Global markets, especially Europe and Asia, are expanding, though pricing varies based on healthcare systems and reimbursement policies.
References
[1] Food and Drug Administration. (2018). Patisiran (Onpattro) approval notice. https://www.fda.gov
[2] EvaluatePharma. (2022). Orphan drug market trends. https://www.evaluate.com
[3] IQVIA. (2022). International drug pricing and reimbursement reports. https://www.iqvia.com
[4] National Organization for Rare Disorders. (2021). hATTR amyloidosis overview. https://rarediseases.org
