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OXLUMO Drug Patent Profile

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

Oxlumo is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are fourteen patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Oxlumo

Oxlumo was eligible for patent challenges on November 23, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 9, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OXLUMO

International Patents:	174
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for OXLUMO
What excipients (inactive ingredients) are in OXLUMO?	OXLUMO excipients list
DailyMed Link:	OXLUMO at DailyMed

See drug prices for OXLUMO

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

Constraining patent/regulatory exclusivity:

10,478,500

NDA:

214103

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.

Recent Clinical Trials for OXLUMO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alnylam Pharmaceuticals	Phase 2
Alnylam Pharmaceuticals	Phase 3

See all OXLUMO clinical trials

US Patents and Regulatory Information for OXLUMO

OXLUMO is protected by fourteen US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,478,500.

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
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	11,401,517		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes
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	8,106,022		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	10,612,027		Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes

International Patents for OXLUMO

When does loss-of-exclusivity occur for OXLUMO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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

See the table below for additional patents covering OXLUMO around the world.

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
European Patent Office	4321177	CONJUGUÉS GLUCIDIQUES UTILISÉS COMME AGENTS D'ADMINISTRATION POUR DES OLIGONUCLÉOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)

Supplementary Protection Certificates for OXLUMO

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
3204015	2022009	Norway		PRODUCT NAME: LUMASIRAN, OPTIONALLY IN THE FORM OF A SALT; REG. NO/DATE: EU/1/20/1496 20201124

OXLUMO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OXLUMO

Introduction to OXLUMO

OXLUMO, also known as lumasiran, is an RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals. It is specifically designed to treat Primary Hyperoxaluria Type 1 (PH1), a rare genetic disorder that affects the liver's ability to metabolize oxalate, leading to the formation of kidney stones and progressive kidney damage.

Mechanism of Action and Clinical Significance

OXLUMO works by blocking the production of the enzyme glycolate oxidase, which is involved in the production of oxalate in the liver. This mechanism reduces the levels of oxalate in the body, thereby managing the symptoms and preventing complications associated with PH1[4].

Regulatory Milestones and Development Activities

Since its approval in 2020, OXLUMO has marked significant regulatory milestones. The drug has been approved in several major markets, including the United States, the European Union, and the United Kingdom. The regulatory approval process has been supported by robust clinical trials that demonstrated the efficacy and safety of OXLUMO in reducing urinary oxalate levels and improving clinical outcomes for patients with PH1[1].

Market Forecast and Growth

The primary hyperoxaluria treatment market, driven significantly by OXLUMO, is expected to grow substantially. The global market for primary hyperoxaluria treatment is projected to increase from $18 million in 2023 to $41.07 million by 2033, at a Compound Annual Growth Rate (CAGR) of 8.6%[4].

Revenue Growth

Alnylam Pharmaceuticals has reported consistent revenue growth driven by OXLUMO. In the second quarter of 2024, global net product revenues for OXLUMO were $62 million, representing a 25% annual growth compared to the same period in 2023. This growth is attributed to increased demand in both the U.S. and international markets[2].

Quarterly and Annual Performance

OXLUMO has shown robust quarterly growth, with a 14% quarter-over-quarter (QoQ) growth in the fourth quarter of 2023, driven by increased demand in the U.S. and international markets. The annual growth for OXLUMO in 2023 was 37%, contributing significantly to the overall ultra-rare franchise growth of Alnylam Pharmaceuticals[3].

Competitive Landscape

The market for primary hyperoxaluria treatments is relatively niche but competitive. OXLUMO faces competition from other emerging therapies, although it remains the first and only targeted therapy approved for PH1. Other companies, such as OxThera, Dicerna Pharmaceuticals, and Allena Pharmaceuticals, are developing therapies that could potentially compete with OXLUMO in the future[4].

Emerging Therapies

The approval of OXLUMO has spurred further research and development in the field. Late-stage emerging therapies are expected to enter the market, which could impact OXLUMO's market share. However, OXLUMO's established position and positive clinical outcomes are likely to maintain its dominance in the near future[1].

Financial Performance of Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, the developer of OXLUMO, has reported strong financial performance driven by its product portfolio, including OXLUMO.

Revenue and Growth

In the second quarter of 2024, Alnylam reported a 34% year-over-year increase in global net product revenues, reaching $410 million. This growth was largely driven by the TTR franchise and the ultra-rare franchise, which includes OXLUMO and GIVLAARI[2].

Cash Position and Operating Expenses

Alnylam maintains a strong cash position, with $2.62 billion in cash and investments as of the second quarter of 2024. Despite a GAAP net loss of $16.9 million in the same period, the company's non-GAAP operating income was $137.9 million, indicating robust financial health and operational efficiency[2].

Market Drivers and Challenges

Increasing Prevalence and Awareness

The increasing prevalence of primary hyperoxaluria and growing awareness of the condition are key drivers of market growth. As more patients are diagnosed and treated, the demand for effective therapies like OXLUMO is expected to rise[4].

Precision Medicine and Personalized Treatments

The growing focus on precision medicine and personalized treatments is another driver. With advancements in genetic testing, there is an opportunity to develop targeted therapies tailored to individual patients' genetic profiles, further boosting the market[4].

Regulatory and Developmental Challenges

Despite the positive outlook, there are challenges related to regulatory approvals and the development of new therapies. The launch of late-stage emerging therapies could impact OXLUMO's market share, and ongoing regulatory milestones must be navigated to maintain market dominance[1].

SWOT Analysis

Strengths

• First-to-Market Advantage: OXLUMO is the first targeted therapy approved for PH1, giving it a significant market advantage.
• Robust Clinical Data: Positive clinical trial results have established OXLUMO's efficacy and safety.
• Strong Financial Backing: Alnylam Pharmaceuticals' robust financial performance supports continued investment in research and development.

Weaknesses

• Dependence on Single Product: A significant portion of Alnylam's revenue is dependent on OXLUMO and other ultra-rare franchise products.
• Potential Competition: Emerging therapies could challenge OXLUMO's market share.

Opportunities

• Growing Market: The increasing prevalence of PH1 and growing awareness offer opportunities for market expansion.
• Precision Medicine: The trend towards precision medicine could lead to more targeted and effective treatments.

Threats

• Regulatory Changes: Changes in regulatory environments could impact approval and market access.
• Competition from Emerging Therapies: New therapies entering the market could compete with OXLUMO.

Analyst Views and Market Projections

Analysts view OXLUMO as a key driver of Alnylam's growth, with positive projections for future sales. The in-depth analysis of forecasted sales data from 2023 to 2032 supports the expectation of continued market dominance for OXLUMO in the primary hyperoxaluria treatment market[1].

Key Takeaways

• Market Growth: The primary hyperoxaluria treatment market is expected to grow significantly, driven by OXLUMO.
• Revenue Performance: OXLUMO has shown robust revenue growth, contributing to Alnylam's overall financial performance.
• Competitive Landscape: While OXLUMO faces potential competition, its first-to-market advantage and strong clinical data position it for continued dominance.
• Regulatory and Developmental Activities: Ongoing regulatory milestones and developmental activities are crucial for maintaining market share.

FAQs

What is OXLUMO used for?

OXLUMO (lumasiran) is used to treat Primary Hyperoxaluria Type 1 (PH1), a rare genetic disorder that affects the liver's ability to metabolize oxalate.

How does OXLUMO work?

OXLUMO works by blocking the production of the enzyme glycolate oxidase, which is involved in the production of oxalate in the liver, thereby reducing oxalate levels in the body.

What is the current market size for primary hyperoxaluria treatments?

The global market for primary hyperoxaluria treatments was valued at $18 million in 2023 and is projected to reach $41.07 million by 2033.

What is the growth rate of the primary hyperoxaluria treatment market?

The market is expected to grow at a CAGR of 8.6% from 2023 to 2033.

Who is the developer of OXLUMO?

OXLUMO is developed by Alnylam Pharmaceuticals.

Sources

1. Research and Markets: "OXLUMO Drug Insight and Market Forecast - 2032"
2. Stocktitan: "Alnylam Pharmaceuticals Reports Second Quarter 2024 Financial Results"
3. Alnylam Pharmaceuticals: "Fourth Quarter and Full Year 2023 Financial Results"
4. Future Market Insights: "Primary Hyperoxaluria Treatment Market Growth & Forecast 2033"
5. Stocktitan: "Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results"