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 one hundred and seventy-four patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for lumasiran sodium

International Patents:	174
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	lumasiran sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

10,478,500

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	11,446,380		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	11,261,447		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	10,131,907		Y	Y
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	10,612,027		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	8,106,022		Y	Y

International Patents for lumasiran sodium

Country	Patent Number	Title	Estimated Expiration
Dominican Republic	P2017000094	COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN HAO1 (HIDROXIÁCIDO-OXIDASA 1 (GLICOLATO-OXIDASA))
Cyprus	1125364
European Patent Office	3186377	AGENTS D'ARN DOUBLE BRIN MODIFIÉ (MODIFIED DOUBLE-STRANDED RNA AGENTS)
Japan	2017002082	標的化脂質 (TARGETED LIPID)
Jordan	P20200115	تركيبات وطرق لتثبيط التعبير الجيني عن HAO1 (حمض أوكسيداز هيدروكسيلي 1 (أوكسيداز جليكولات)) (Compositions And Methods For Inhibition Of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) Gene Expression)
World Intellectual Property Organization (WIPO)	2016028649

Supplementary Protection Certificates for lumasiran sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3581654	2021038	Norway		PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201124
3204015	2022C/509	Belgium		PRODUCT NAME: LUMASIRAN, INCLUSIEF ZOUTEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1496 20201123
3204015	PA2022004	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/120/1496 20201119
3581654	122021000053	Germany		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201119
3581654	PA2021008,C3581654	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/1/20/1496 20201119
3204015	22C1016	France		PRODUCT NAME: LUMASIRAN, OPTIONNELLEMENT SOUS FORME DE SEL; NAT. REGISTRATION NO/DATE: EU/1/20/1496 20201123; FIRST REGISTRATION: - EU/1/20/1496 20201123

Lumasiran sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lumasiran Sodium

Introduction to Lumasiran Sodium

Lumasiran sodium, marketed as OXLUMO, is a small interfering RNA (siRNA) therapeutic agent developed by Alnylam Pharmaceuticals. It is specifically designed to treat primary hyperoxaluria type 1 (PH1), a rare genetic disorder characterized by the excessive production of oxalate, leading to kidney stones and other severe complications.

Market Size and Growth Projections

The global lumasiran market is poised for significant growth. As of 2024, the market size was valued at USD 181.95 million and is projected to reach USD 572.27 million by 2032, with a Compound Annual Growth Rate (CAGR) of 15.40% during the forecast period of 2025 to 2032[1].

Key Drivers of Market Growth

Increasing Incidence of PH1 and Demand for Effective Therapies

The rising incidence of PH1 and the growing demand for effective therapeutic solutions are primary drivers of the lumasiran market. Lumasiran has demonstrated efficacy in reducing urinary oxalate levels, addressing a critical unmet need in PH1 treatment[1].

Regulatory Approvals and Expansion

The FDA and European Union approvals of lumasiran mark significant milestones in its market trajectory. These approvals have facilitated its adoption across various age groups, including pediatric and adult patients[4].

Research and Development Initiatives

Investments in research and development (R&D) are crucial for expanding lumasiran's indications beyond PH1. Studies exploring its efficacy in other forms of hyperoxaluria or related metabolic disorders could open new avenues for its application, attracting a broader patient population[1].

Geographical Market Dynamics

North America

North America leads the lumasiran market, driven by the presence of prominent pharmaceutical companies, a high prevalence of PH1, and a well-established healthcare infrastructure. Government support for R&D initiatives further enhances the market landscape in this region[1].

Asia-Pacific

The Asia-Pacific region is projected to experience substantial growth due to increasing emphasis on developing therapies for rare diseases. Rising social awareness and government support for R&D are key factors driving this growth[1].

Market Segmentation

The lumasiran market is segmented by drug class, application, dosage form, route of administration, demographic, end-users, and distribution channels. Key segments include:

• Drug Class: Miscellaneous Metabolic Agents and Others
• Application: Primary Hyperoxaluria and Others
• Dosage Form: Injection and Solution
• Route of Administration: Subcutaneous
• Demographic: Adult and Pediatric
• End-Users: Clinics, Hospitals, Diagnostic Centers, and Others
• Distribution Channel: Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy[1].

Competitive Landscape

Market Leaders

Alnylam Pharmaceuticals, Inc. is the primary market leader in the lumasiran market. The company's strong focus on R&D, global presence, and innovative technologies such as Enhanced Stabilization Chemistry (ESC)-GalNAc conjugate technology have positioned lumasiran as a cornerstone in PH1 treatment[1][4].

Financial Performance and Trajectory

Alnylam Pharmaceuticals' Financials

Alnylam Pharmaceuticals has demonstrated impressive financial performance over the years. An investment of $100 in ALNY stock 20 years ago would be worth approximately $4,144.21 today, reflecting an average annual return of 21.02%. The company's market capitalization currently stands at $29.88 billion[3].

Revenue Growth

The significant growth in the lumasiran market is expected to contribute substantially to Alnylam Pharmaceuticals' revenue. With a projected CAGR of 15.40%, the market is anticipated to drive robust financial growth for the company over the forecast period[1].

Efficacy and Safety

Clinical Efficacy

Lumasiran has shown remarkable efficacy in clinical trials and real-world settings. It reduces plasma and urinary oxalate levels, stabilizes glomerular filtration rate (GFR), and improves renal stone disease. The ILLUMINATE trials and real-world data have consistently supported its effectiveness in managing PH1[2][4].

Safety Profile

Lumasiran has a good tolerability profile with minimal adverse events. The most common drug-related adverse reaction is injection site reactions (ISRs). Long-term data indicate that lumasiran is not associated with significant adverse events, making it a safe therapeutic option for patients with PH1[2][5].

Restraints and Challenges

Market Access and Pricing

Despite its efficacy, market access and pricing remain significant challenges. High costs associated with innovative therapies like lumasiran can limit access, especially in regions with less robust healthcare infrastructures[1].

Future Outlook

The future outlook for the lumasiran market is promising, driven by ongoing R&D, expanding indications, and increasing awareness of rare diseases. As healthcare providers and patients recognize the importance of early intervention and effective treatment options, lumasiran is likely to continue its robust growth trajectory.

Key Takeaways

• The global lumasiran market is projected to grow from USD 181.95 million in 2024 to USD 572.27 million by 2032.
• Key drivers include increasing incidence of PH1, regulatory approvals, and R&D initiatives.
• North America and Asia-Pacific are significant markets due to their healthcare infrastructure and growing awareness of rare diseases.
• Alnylam Pharmaceuticals is the leading player, with a strong financial performance and innovative technologies.
• Lumasiran has demonstrated high efficacy and safety in clinical trials and real-world settings.

FAQs

1. What is Lumasiran Sodium used for?

Lumasiran sodium, marketed as OXLUMO, is used for the treatment of primary hyperoxaluria type 1 (PH1), a rare genetic disorder characterized by excessive oxalate production.

2. Who is the primary market leader in the lumasiran market?

Alnylam Pharmaceuticals, Inc. is the primary market leader in the lumasiran market.

3. What is the projected market size of lumasiran by 2032?

The global lumasiran market is projected to reach USD 572.27 million by 2032.

4. What are the key drivers of the lumasiran market growth?

Key drivers include the increasing incidence of PH1, regulatory approvals, and ongoing R&D initiatives.

5. What is the safety profile of lumasiran?

Lumasiran has a good tolerability profile with minimal adverse events, the most common being injection site reactions (ISRs).

Cited Sources:

1. Data Bridge Market Research - Global Lumasiran Market Size, Overview, Scope, Trends & Forecast By 2032
2. PMC - Lumasiran treatment in pediatric patients with PH1: real-world data
3. Quantisnow - $100 Invested In This Stock 20 Years Ago Would Be Worth $4,100 Today
4. Alnylam Pharmaceuticals - Alnylam Receives Approval for OXLUMO™ (lumasiran) in the European Union
5. CADTH Reimbursement Review - Lumasiran (Oxlumo)