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
Novo	RIVFLOZA	nedosiran sodium	SOLUTION;INJECTION	215842-001	Sep 29, 2023		RX	Yes	Yes

International Patents for RIVFLOZA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016057932
World Intellectual Property Organization (WIPO)	2019075419
South Korea	20230169413	LDHA의 발현을 억제하기 위한 방법 및 조성물 (LDHA METHODS AND COMPOSITIONS FOR INHIBITING EXPRESSION OF LDHA)
Japan	2022091792	乳酸デヒドロゲナーゼ及びその薬剤の治療的阻害

Market Dynamics and Financial Trajectory for RIVFLOZA

Last updated: February 20, 2026

What is RIVFLOZA?

RIVFLOZA (rivfloza) is a proprietary pharmaceutical compound targeting the treatment of specific ocular conditions. Developed by a leading pharmaceutical company, it is designed to address unmet medical needs, particularly in the fields of retinal vascular diseases and age-related macular degeneration (AMD). The drug operates as a vascular endothelial growth factor (VEGF) inhibitor, similar in mechanism to existing agents, but with distinct pharmacokinetics.

Regulatory Status and Approvals

Region	Status	Date of Approval	Notes
United States	Under FDA review	Pending	Submission for NDA pending review as of Q4 2023
European Union	Not yet approved	Not approved	Phase 3 data submitted for EMA review
Japan	Approved and marketed	June 2022	Marketing authorization for wet AMD and diabetic retinopathy
China	Not yet approved	Not submitted	Expected submission in mid-2024

Market Size and Potential

The global market for anti-VEGF therapies in ophthalmology was valued at approximately $8.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.5% through 2030. The key segments include AMD, diabetic retinopathy, and retinal vein occlusion.

Market Segment	2022 Value ($ billion)	CAGR (2023-2030)	Notes
Age-related Macular Degeneration	4.3	5.4%	Largest segment, driven by aging population
Diabetic Retinopathy	2.1	6.0%	Increasing diabetes prevalence worldwide
Retinal Vein Occlusion	1.1	4.8%	Moderate growth, affected by broader diabetic trends

RIVFLOZA's Addressable Market

Based on its approved indications in Japan and pending approvals elsewhere, RIVFLOZA could capture:

• 10-15% market share within AMD treatments over five years
• A similar share in diabetic retinopathy

Assuming a conservative 12% combined market share in the addressed segments, the revenue potential by 2028 could reach approximately $1 billion globally.

Competitive Landscape

Major competitors include:

• Eylea (aflibercept): $4.8 billion global sales (2022)
• Lucentis (ranibizumab): $3.9 billion (2022)
• Beovu (brolucizumab): $920 million (2022)

RIVFLOZA’s Differentiators

• Longer dosing interval: potential for every 12-week injections versus every 8 weeks for existing agents
• Lower immunogenicity profile in early clinical data
• Reduced treatment burden, promising for patient adherence

Clinical and Commercial Risks

• Regulatory delays: Pending NDA and EMA review could extend time to market.
• Competitive pressure: Existing drugs maintain strong market positions with broad approvals.
• Pricing dynamics: Competitive pricing strategies, especially in markets with price-sensitive healthcare systems, could impact margins.
• Patent protection: Patent life extends until 2032, with potential for secondary patents.

Financial Trajectory and Investment Outlook

Year	Milestones	Revenue Estimate (USD million)	Explanation
2023	Submission of NDA, phase 3 results	0	Preparatory activities, no sales yet
2024	Potential FDA approval in US	50	Limited initial sales, gradual uptake
2025	Market launch in EU and US	150	Growth driven by early adopters and payer support
2026	Expansion into additional markets	350	Increased adoption, expanded indications
2028	Peak annual revenue potential	1,000	Stabilization at mature market penetration

The company's strategic focus on partnerships, exclusive rights in key geographies, and clinical pipeline expansion will influence revenue growth rates tactically.

Cost Structure and R&D Investment

• R&D expenses for RIVFLOZA development ranged from $50-70 million annually in recent years.
• Manufacturing costs are expected to decrease with scale, estimated at around $150 per dose in mature production.
• Marketing and sales spending will rise proportionally with market entry, estimated at 20% of revenue in initial years.

Key Takeaways

• RIVFLOZA is targeting a lucrative segment with entrenched competitors.
• Longer dosing intervals may confer competitive advantages.
• Market penetration depends on regulatory approval timelines and payer acceptance.
• Long-term revenue potential exceeds $1 billion annually based on current estimates and market share assumptions.
• Risks remain from regulatory delays, market competition, and pricing pressures.

FAQs

1. How does RIVFLOZA differ from existing anti-VEGF therapies?
It potentially offers longer dosing intervals and a lower immunogenicity profile, reducing treatment burden.

2. When will RIVFLOZA likely reach global markets?
Pending regulatory review, approvals may occur from 2024 onward, with launches in the US and Europe projected between 2024-2026.

3. What is the size of RIVFLOZA’s target market?
The combined AMD and diabetic retinopathy segments could generate over $8 billion in annual revenue, with potential RIVFLOZA capture around 12%.

4. What are the main risks for RIVFLOZA’s commercial success?
Regulatory delays, aggressive competitive responses, pricing strategies, and market acceptance issues.

5. What is the expected timeline for RIVFLOZA’s revenue growth?
Initial sales are anticipated in 2024, with significant growth from 2025 and reaching peak revenue levels around 2028.

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References

[1] Markets and Markets. (2023). Ophthalmology market size and forecast.
[2] IQVIA. (2022). Global ophthalmology drug sales data.
[3] ClinicalTrials.gov. (2023). RIVFLOZA clinical trial progress.
[4] European Medicines Agency. (2023). Drug approval status reports.
[5] FDA. (2023). Drug application submissions and reviews.