NEDOSIRAN SODIUM - Generic Drug Details

What are the generic drug sources for nedosiran sodium and what is the scope of patent protection?

Nedosiran sodium is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nedosiran sodium has forty-one patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for NEDOSIRAN SODIUM

International Patents:	41
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	NEDOSIRAN SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEDOSIRAN SODIUM

Constraining patent/regulatory exclusivity:

11,053,502

Dosage:

SOLUTION;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for NEDOSIRAN SODIUM

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for NEDOSIRAN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-002	Sep 29, 2023		RX	Yes	Yes	10,738,311		Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-001	Sep 29, 2023		RX	Yes	Yes	11,053,502		Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-002	Sep 29, 2023		RX	Yes	Yes	10,351,854		Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-001	Sep 29, 2023		RX	Yes	Yes	11,286,488		Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-002	Sep 29, 2023		RX	Yes	Yes

International Patents for NEDOSIRAN SODIUM

Country	Patent Number	Title	Estimated Expiration
Israel	251643	מעכב טיפולי של לקטאט דיהידרוגנאז וגורמים שלהם (Therapeutic inhibition of lactate dehydrogenase and agents therefor)
China	107257858	乳酸脱氢酶的治疗性抑制及其试剂 (Therapeutic inhibition of lactate dehydrogenase and agents therefor)
Croatia	P20231063
Denmark	3204497
Poland	3679141

Last updated: February 16, 2026

What Are the Market Dynamics for Nedosiran Sodium?

Nedosiran sodium is a therapeutic agent developed for the treatment of primary hyperoxaluria (PH), a rare genetic disorder characterized by overproduction of oxalate, leading to kidney stones and kidney failure. The drug's market potential depends on the prevalence of PH, current treatment options, regulatory approvals, and competitive landscape.

Disease Market Landscape

• Prevalence: Primary hyperoxaluria affects approximately 1-3 per million people globally, with type 1 being the most common and severe. Estimated annual diagnosed case volume: approximately 5,000 to 10,000 patients worldwide.
• Unmet Need: No approved targeted therapies specifically for PH until recent advancements, resulting in reliance on supportive treatments like dialysis and transplantation.

Regulatory and Approval Status

• FDA & EMA: Clinical-stage development; no final approvals issued as of early 2023.
• Fast Track/Orphan Designations: Potential designations may accelerate approval processes, increasing commercial attractiveness.

Market Drivers and Barriers

• Drivers:
  • Rising awareness of PH
  • Successful clinical trial outcomes demonstrating efficacy
  • Adoption of RNA interference (RNAi) therapies in rare diseases
  • Increasing investment from biotech giants in rare disease portfolios
• Barriers:
  • Limited patient population
  • High development costs
  • Competition from existing supportive therapies and emerging treatments

Competitive Landscape

• Current and Emerging Therapies:
  • Supportive management, including hydration and dialysis
  • Liver transplantation remains the only definitive treatment for some
  • RNAi-based therapies targeting oxalate biosynthesis under development, potentially positioning nedosiran sodium as a first-in-class agent if approved

What Is the Financial Trajectory for Nedosiran Sodium?

The financial outlook hinges on commercialization, market penetration, pricing, reimbursement, and scalability.

Revenue Projections

• Market Entry Year: Likely 2024-2025, contingent on successful clinical trial data and regulatory review.
• Pricing Assumption: Estimated at $250,000 to $500,000 annually per patient, based on pricing trends for orphan RNAi drugs.
• Market Penetration:
  • Conservative scenarios project capturing 20% of the diagnosed patient pool within 5 years of launch.
  • High-end scenarios with aggressive adoption could capture 50% or more.

Year	Estimated Patients Treated	Estimated Revenue (USD Millions)
2024	50-200	12.5 - 100
2025	200-600	50 - 300
2026	400-1,200	100 - 600
2027	800-2,400	200 - 1,200

Cost Structure

• R&D Spending: Initial high expenditure during clinical phases, tapering off post-approval.
• Manufacturing Costs: Expected to decline with scale, production costs estimated at 20-30% of sale price.
• Commercial Expenses: Marketing, physician outreach, and patient support programs will influence profit margins.

Profitability Outlook

• Break-even could occur within 4-6 years post-commercialization, considering high fixed R&D investments and variable manufacturing and marketing costs.
• Potential for revenue growth to surpass $1 billion annually if market penetration accelerates and pricing is maintained.

How Do External Factors Affect Financial Outcomes?

• Policy & Pricing Regulations: Orphan drug exclusivity and pricing freedom in certain markets can enhance revenue.
• Reimbursement Policies: Payers' willingness to reimburse high-cost orphan drugs will influence revenue.
• Pipeline Developments: Advances in competing therapies may curtail market share.
• Manufacturing Scalability: Efficient scaling may reduce costs but requires significant capital investment.

Key Takeaways

• Nedosiran sodium addresses an unmet medical need in primary hyperoxaluria, with clinical development ongoing.
• Market adoption will depend on regulatory approvals, pricing strategies, and payer acceptance.
• Revenue projections suggest potential peak sales of several hundred million dollars annually within 5 years of market entry.
• Cost structure and reimbursement policies will significantly influence long-term profitability.
• Competitive landscape and emerging therapies pose risks to market share.

FAQs

1. When is nedosiran sodium expected to be commercially available?
Likely between 2024 and 2025, contingent on positive clinical trial outcomes and regulatory approval processes.

2. What is the main revenue driver for nedosiran sodium?
A high price point driven by orphan drug designation and small patient population, combined with targeted marketing to specialist centers.

3. How does nedosiran sodium compare with existing treatments?
It is designed as a targeted RNAi therapy aimed at reducing oxalate production, potentially offering a disease-modifying approach beyond supportive management and transplantation.

4. What factors could impede financial success?
Delayed approval, unfavorable reimbursement, lower-than-expected market uptake, or the emergence of superior therapies.

5. What is the competitive advantage of nedosiran sodium?
If approved, it would be among the first therapies specifically addressing the root cause of PH, particularly for type 1, offering potentially transformative benefits.

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Sources
[1] ClinicalTrials.gov. "Nedosiran Phase 3 Trials"
[2] EvaluatePharma. Orphan Drug Pricing Data 2022
[3] Steer Group Reports. Rare Disease Market Analysis 2023