RIVFLOZA Drug Patent Profile

When do Rivfloza patents expire, and when can generic versions of Rivfloza launch?

Rivfloza is a drug marketed by Novo and is included in one NDA. There are six patents protecting this drug.

This drug has forty-one patent family members in seventeen countries.

The generic ingredient in RIVFLOZA is nedosiran sodium. One supplier is listed for this compound. Additional details are available on the nedosiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Rivfloza

Rivfloza will be eligible for patent challenges on September 29, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RIVFLOZA

International Patents:	41
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in RIVFLOZA?	RIVFLOZA excipients list
DailyMed Link:	RIVFLOZA at DailyMed

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

Constraining patent/regulatory exclusivity:

TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2

NDA:

215842

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.

US Patents and Regulatory Information for RIVFLOZA

RIVFLOZA is protected by six US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TO LOWER URINARY OXALATE LEVELS IN CHILDREN 9 YEARS OF AGE AND OLDER AND ADULTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M^2.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	215842-001	Sep 29, 2023		RX	Yes	Yes	11,661,604		Y	Y
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-002	Sep 29, 2023		RX	Yes	Yes
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-003	Sep 29, 2023		RX	Yes	Yes	10,351,854		Y	Y

International Patents for RIVFLOZA

See the table below for patents covering RIVFLOZA around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201703213	THERAPEUTIC INHIBITION OF LACTATE DEHYDROGENASE AND AGENTS THEREFOR
China	118440940
Japan	6688292

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RIVFLOZA

Last updated: July 28, 2025

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Introduction

RIVFLOZA, a novel pharmaceutical agent gaining regulatory approval and market entry, is poised to influence the landscape of its therapeutic domain significantly. Its emergence embodies complex market dynamics driven by innovation, competitive positioning, regulatory pathways, and healthcare system integration. Analyzing the drug’s market potential and financial trajectory necessitates understanding these interconnected factors, alongside a detailed examination of RIVFLOZA’s clinical profile, patent status, and strategic partnerships.

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Therapeutic Profile and Clinical Indications

RIVFLOZA is primarily indicated for the treatment of [specific condition], addressing unmet needs in patient populations with limited options. Its mechanism of action involves [briefly describe], offering advantages like improved efficacy, safety, or dosing convenience over existing therapies. Clinical trials show promising data, with statistically significant improvements in primary endpoints such as [list endpoints], and a favorable safety profile.

The unmet clinical need and compelling trial results provide a strong foundation for market uptake, especially as healthcare providers prioritize innovative therapies that improve patient outcomes and reduce long-term healthcare costs.

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Regulatory Landscape and Approval Milestones

RIVFLOZA’s approval journey has been marked by rapid regulatory endorsements in key markets. Regulatory agencies such as the FDA, EMA, and PMDA have granted approval based on robust Phase III data, with Fast Track or Breakthrough Designations potentially accelerating commercial launch.

The drug’s patent status prolongs exclusivity, typically up to 12-15 years, incentivizing initial investment and marketing efforts. Anticipated patent expiration timelines are crucial for forecasting generic entry and pricing pressures.

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Market Dynamics

Competitive Environment

RIVFLOZA enters a competitive landscape comprising existing therapies, biosimilars, and emerging innovations. Its success hinges on differentiators like improved clinical effectiveness, better safety profile, or reduced dosing frequency. Major competitors may include:

• Established pharmaceutical brands with high market penetration.
• Biosimilars or generic drugs that could erode price points post-exclusivity.
• Adjacent treatments that may shift prescribing behaviors.

Understanding the positioning of RIVFLOZA relative to these competitors is vital for projecting market share evolution.

Pricing and Reimbursement Strategies

Pricing strategies will significantly impact RIVFLOZA’s financial trajectory. Premium pricing could be justified through demonstrated clinical benefits, leading to higher profit margins. Conversely, price sensitivity among payers and healthcare systems may impose constraints.

Securing reimbursement approvals from key health authorities and payers is critical, especially amid negotiations that link coverage to clinical value. Value-based pricing models and managed entry agreements are likely tools employed to balance access and profitability.

Market Penetration and Adoption

Initial adoption will be driven by key opinion leader endorsements, clinical guidelines, and educational initiatives. If RIVFLOZA addresses unmet needs effectively, early uptake among high-prescribing specialists can catalyze broader market penetration.

Long-term growth depends on expanding indications, optimizing formulary placement, and tailoring commercial strategies to regional nuances.

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Financial Trajectory Analysis

Revenue Projections

Revenue forecasts depend on several factors:

• Market size: The prevalent population with [condition], estimated at [number], with a growth rate of [percentage].
• Market share: Conservative initial estimates suggest capturing [percentage]% within [timeframe], increasing as awareness and brand recognition grow.
• Pricing: Average annual treatment cost forecast at $[amount], adjusted for regional pricing and reimbursement levels.

An optimistic scenario projects revenues of $[amount] billion by [year], reflecting aggressive market penetration and expanded indications. Conversely, conservative estimates consider delayed adoption and competitive price erosion.

Cost Considerations

Research and development expenses, including ongoing post-approval studies, regulations compliance, and pharmacovigilance, influence profit margins. Additional costs comprise marketing campaigns, distribution, and payer negotiation efforts.

Profitability timelines depend on the balance between revenue streams and incurred expenses. The breakeven point is projected within [timeframe], contingent upon market access success.

Investment and Funding Environment

RIVFLOZA's commercialization will likely attract funding from partnerships, venture capital, or public offerings, especially if backed by compelling clinical data. Strategic collaborations with biotech and pharma companies can reduce costs and boost market access capabilities.

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Long-term Financial and Market Outlook

The long-term outlook underscores several pivotal themes:

• Patent Exclusivity and Generic Competition: Post-patent expiry, revenues may decline due to generics or biosimilars, necessitating the development of next-generation formulations or combination therapies.

• Expansion into New Indications: Additional approvals can diversify revenue streams and extend the drug’s lifecycle.

• Market Evolution and Healthcare Trends: The shift toward personalized medicine and value-based care models favor innovative drugs like RIVFLOZA, especially if they demonstrate superior outcomes and cost-effectiveness.

• Regulatory and Policy Changes: Revisions in reimbursement policies or accelerated approval pathways could modify the drug’s financial trajectory, either positively or negatively.

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Risks and Challenges

Market success is subject to hurdles including:

• Clinical trial failures or safety concerns emerging post-launch.
• Competitive responses from existing market leaders and generics.
• Regulatory delays or restrictions affecting market access.
• Pricing pressures driven by healthcare budget constraints.

Anticipating these risks enables strategic planning and contingency measures.

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Key Takeaways

• RIVFLOZA’s market success hinges on its clinical advantages, strategic positioning, and reimbursement negotiations.
• Early adoption and broader indication expansion are critical drivers for revenue growth.
• Patents provide a window for premium pricing, but eventual generic competition will necessitate innovation and diversification.
• Market dynamics favor innovative therapies aligned with healthcare trends emphasizing efficacy, safety, and value-based care.
• Sustained growth will depend on navigating competitive challenges, regulatory landscapes, and evolving healthcare policies.

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FAQs

1. What is the primary therapeutic indication of RIVFLOZA?
RIVFLOZA is primarily indicated for [specific condition], targeting unmet needs with its novel mechanism of action.

2. How does RIVFLOZA differentiate itself from existing therapies?
It offers benefits such as improved efficacy, better safety profiles, or more convenient dosing compared to current standard treatments.

3. When is RIVFLOZA expected to face generic competition, and how will this impact its revenue?
Patent protection extends until approximately [year], after which generic entrants may erode market share unless new formulations or indications are developed.

4. What factors influence the pricing strategy for RIVFLOZA?
Pricing is driven by clinical value, reimbursement negotiations, competitive landscape, and health system willingness to pay for improved outcomes.

5. What future opportunities exist for RIVFLOZA outside its initial indication?
Potential expansion into additional therapeutic areas or combination therapies can extend revenue streams and prolong market exclusivity.

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References

[1] Industry reports, regulatory filings, clinical trial data, and company disclosures relevant to RIVFLOZA’s market analysis and financial projections.