Lumasiran sodium - Generic Drug Details

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

Lumasiran sodium is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lumasiran sodium has two hundred and one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for lumasiran sodium

International Patents:	201
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lumasiran sodium
DailyMed Link:	lumasiran sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

11,446,380

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 lumasiran 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 lumasiran sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	8,828,956		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	9,828,606		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	10,612,024		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	10,435,692
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	11,060,093		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	10,478,500		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	11,446,380		Y	Y

International Patents for lumasiran sodium

Country	Patent Number	Title	Estimated Expiration
Australia	2008242583
Canada	2685127
World Intellectual Property Organization (WIPO)	2008131419
Australia	2014369850
Australia	2021201953
Canada	2935220
Cyprus	1124203

Supplementary Protection Certificates for lumasiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3581654	CA 2021 00038	Denmark		PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201123
3581654	SPC/GB21/059	United Kingdom		PRODUCT NAME: LUMASIRAN; REGISTERED: UK EU 1/20/1496 (NI) 20201123; UK PLGB 50597/0005 20201123
3204015	CA 2022 00011	Denmark		PRODUCT NAME: LUMASIRAN EVENTUELT I FORM AF ET SALT; REG. NO/DATE: EU/1/20/1496 20201123
3581654	C20210019 00342	Estonia		PRODUCT NAME: LUMASIRAAN;REG NO/DATE: EU/1/20/1496 23.11.2020
3581654	PA2021008,C3581654	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/1/20/1496 20201119
3204015	C20220010 00364	Estonia		PRODUCT NAME: LUMASIRAAN;REG NO/DATE: EU/1/20/1496 23.11.2020
3581654	2190038-6	Sweden		PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201123

Last updated: February 16, 2026

What Is the Current Market Status of Lumasiran Sodium?

Lumasiran sodium (brand name: Oxlumo) received FDA approval in November 2020. It is indicated for treating primary hyperoxaluria type 1 (PH1), a rare genetic disorder causing excessive oxalate production. Market expectation hinges on its approval and adoption rates, driven by its status as the first RNA interference (RNAi) therapy for PH1.

Market Size and Revenue Performance

• Initial Sales: In 2021, Oxlumo generated approximately $40 million globally. In 2022, revenues increased to nearly $70 million, driven by increasing awareness and expanded patient identification.
• Growth Rate: The compound annual growth rate (CAGR) from 2021 to 2022 is approximately 75%. Forecasts project continued acceleration, with revenues potentially surpassing $150 million by 2026, assuming successful market penetration.
• Market Share: As the only approved therapy specifically targeting PH1, Oxlumo holds a near-monopoly status within its niche. Competitors are in early development phases or pursuing alternative approaches.

Market Penetration Challenges and Opportunities

• Diagnosis Delay: PH1 remains underdiagnosed, with diagnoses often occurring late in disease progression. This limits immediate addressable market and delays revenue growth.
• Treatment Adoption: Physicians favor proprietary therapies with demonstrated efficacy and manageable safety profiles. Current barriers include high costs and limited long-term data.
• Pricing: The drug's list price exceeds $400,000 annually per patient, influencing both access and payer negotiations. Insurance coverage varies across markets, affecting market expansion.

What Are the Key Market Drivers and Barriers?

Drivers

• Unmet Medical Need: PH1 is a life-threatening disease with limited treatment options before Oxlumo.
• Regulatory Approvals: FDA approval and subsequent approvals in European markets mark a regulatory milestone, broadening access.
• R&D Investments: The company developing Oxlumo is investing in clinical trials for related indications, which could expand its addressable market.

Barriers

• Pricing and Reimbursement: High costs pose reimbursement challenges, affecting adoption, especially in cost-sensitive healthcare systems.
• Patient Awareness: Low disease awareness hampers early diagnosis and treatment initiation.
• Long-term Data: Lack of extended safety and efficacy data restricts physician confidence, impacting overall market penetration.

How Does Lumasiran Sodium Compare to Rival Therapies?

As of now, no direct competitors have received regulatory approval for PH1. However, alternative approaches include:

• High-Volume Dialysis: Conventional management through dialysis has limited efficacy and quality-of-life impact.
• Liver Transplantation: Offers potential cure but involves high risk and limited donor availability.
• Emerging RNAi or gene-silencing therapies: Several biotech companies are entering the space but remain in clinical phases.

What Is the Financial Trajectory for the Coming Years?

Revenue Forecasts

Year	Estimated Revenue	Sources / Assumptions
2023	$100 - $120 million	Steady adoption increase, expanding geographic reach, insurance coverage improvements
2024	$150 - $200 million	With broader awareness, higher diagnosis rates, and more treatment centers adopting therapy
2025	$250 million+	Scaling globally, potential expansion into related indications, and additional formulations or dosing options

Cost and Pricing Factors

• Cost of Goods Sold (COGS): Projected at approximately 20-25% of revenue, factoring in manufacturing expenses.
• Research & Development: Continued R&D investments for second-generation therapies and indications may impact profitability.
• Pricing Variability: Payer negotiations and formulary placements significantly influence revenue realization.

What Are the Future Investment and R&D Trends?

Investments predominantly target:

• Efficacy Improvements: Developing formulations with less frequent dosing or better safety profiles.
• Expanding Indications: Exploring use for other hyperoxaluria types and related kidney conditions.
• Combination Therapies: Investigating combined use with other treatments to enhance outcomes.

Key Takeaways

• Lumasiran sodium has rapidly gained market penetration as the first approved RNAi therapy for PH1.
• Revenue growth is robust but constrained by diagnosis delays, high costs, and reimbursement hurdles.
• Market expansion depends on increasing disease awareness, improved diagnostics, and acceptance by payers and clinicians.
• No direct competitors exist in the near term, but emerging therapies could challenge its market position.
• Long-term financial success hinges on demonstrating durability of efficacy, safety, and cost-effectiveness.

FAQs

1. What is the primary mechanism of action for lumasiran sodium?
It uses RNA interference technology to silence the hydroxyacid oxidase 1 (HAO1) gene, reducing oxalate production.

2. How does lumasiran sodium compare with other treatments for PH1?
It offers targeted therapy with better safety profiles than liver transplantation and more effective than dialysis alone.

3. What are the main challenges in scaling the market for oxlumo?
Diagnosis delays, high drug costs, reimbursement issues, and limited disease awareness.

4. Are there ongoing trials for other indications?
Yes, trials are underway for other hyperoxaluria subtypes and related renal conditions.

5. How might biosimilar or generic versions affect future profitability?
Given the novelty and complexity, biosimilars are unlikely in the immediate future. Patent exclusivity could last until 2030 or later.

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Cited Sources

1. U.S. Food and Drug Administration. (2020). FDA approves Oxlumo to treat primary hyperoxaluria type 1.
2. EvaluatePharma. (2022). Market projections for lumasiran and RNAi therapies.
3. Company financial reports and investor presentations (Alnylam Pharmaceuticals).