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 ninety-seven patent family members in forty-five 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.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OXLUMO

International Patents:	197
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for OXLUMO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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 two FDA Regulatory Exclusivities.

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			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			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			Y	Y

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

Finland

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

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
Spain	2749855
Serbia	61892	POSTUPCI I KOMPOZICIJE ZA SPECIFIČNU INHIBICIJU GLIKOLAT OKSIDAZE (HAO1) POMOĆU DVOLANČANE RNK (METHODS AND COMPOSITIONS FOR THE SPECIFIC INHIBITION OF GLYCOLATE OXIDASE (HAO1) BY DOUBLE-STRANDED RNA)
World Intellectual Property Organization (WIPO)	2015100436
Japan	2011505425
New Zealand	730404
Australia	2014369850	Methods and compositions for the specific inhibition of Glycolate Oxidase (HAO1) by double-stranded RNA
Colombia	2017004728

Supplementary Protection Certificates for OXLUMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3204015	C03204015/01	Switzerland		PRODUCT NAME: LUMASIRANUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68239 01.12.2021
3204015	C20220010 00364	Estonia		PRODUCT NAME: LUMASIRAAN;REG NO/DATE: EU/1/20/1496 23.11.2020
3581654	202140021	Slovenia		PRODUCT NAME: LUMASIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1496/001; DATE OF NATIONAL AUTHORISATION: 20201119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3581654	38/2021	Austria		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 (MITTEILUNG) 20201123
3204015	202240010	Slovenia		PRODUCT NAME: LUMASIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1496/001; DATE OF NATIONAL AUTHORISATION: 20201119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3581654	LUC00218	Luxembourg		PRODUCT NAME: LUMASIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1496 20201123
3204015	2290011-2	Sweden		PRODUCT NAME: LUMASIRAN, OPTIONALLY IN THE FORM OF A SALT; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/20/1496, 2020-11-23; 1290041-1, 2190036-0, 1390005-5, 1490063-3, 2090018-9, 1490027-8, 1990004-2, 2290011-2, 1390026-1 2090037-9, 2390008-7, 2290049-2: SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG (BESLUT I PMAE 7804-24).

OXLUMO: Patent Exclusivity and Market Potential

Last updated: February 19, 2026

Oxlumo (lumasiran) generated $553 million in revenue in 2023, a 23% increase from the prior year, driven by strong patient uptake and expanded indications. The drug, developed by Alnylam Pharmaceuticals, targets unmet needs in rare genetic diseases. Key to its sustained market position are its remaining patent protections, which extend through 2040, providing a significant period of market exclusivity against potential generic competition.

What are Oxlumo's Primary Indications?

Oxlumo is approved for the treatment of primary hyperoxaluria type 1 (PH1) and advanced chronic kidney disease (CKD) in patients with PH1. PH1 is a rare genetic disorder characterized by the overproduction of oxalate, leading to kidney stone formation, kidney damage, and systemic oxalosis. Oxlumo works by inhibiting the hepatic production of glycolate oxidase (GO), an enzyme that plays a role in oxalate synthesis. This mechanism addresses the root cause of excessive oxalate production in PH1 patients.

Primary hyperoxaluria type 1 affects approximately 1 in 30,000 to 1 in 1,000,000 individuals worldwide. In the United States, it is estimated to affect 1 in 100,000 people. The disease can manifest in infancy or adulthood and is associated with significant morbidity and mortality if left untreated.

The initial approval for PH1 was granted by the U.S. Food and Drug Administration (FDA) in December 2020 and by the European Medicines Agency (EMA) shortly thereafter. The expanded indication for advanced CKD in PH1 patients was approved in the U.S. in November 2021, broadening the eligible patient population.

What is Oxlumo's Financial Performance?

Oxlumo has demonstrated consistent revenue growth since its launch. In 2023, global net product revenues for Oxlumo reached $553 million. This represents a 23% increase compared to the $450 million reported in 2022 and a substantial rise from the $292 million recorded in 2021.

The year-over-year growth is attributed to several factors:

• Increased Patient Adoption: A growing number of eligible PH1 patients are being diagnosed and treated with Oxlumo.
• Label Expansion: The approval for advanced CKD patients expanded the addressable market.
• Geographic Penetration: Increased market access and reimbursement in key global markets.

Alnylam Pharmaceuticals projects continued growth for Oxlumo, with management guidance anticipating net sales to be between $575 million and $625 million in 2024. This forecast suggests a projected year-over-year growth rate of approximately 4% to 9%.

The cost of Oxlumo is a significant factor in its revenue generation. The list price for Oxlumo is approximately $450,000 per year per patient, though actual net revenue is lower due to rebates and discounts. The high cost reflects the rare nature of the disease and the innovative therapeutic approach.

What is the Patent Landscape for Oxlumo?

Alnylam Pharmaceuticals holds robust patent protection for Oxlumo, which is critical for its market exclusivity. The core patents protecting Oxlumo's active pharmaceutical ingredient, lumasiran, and its methods of use are expected to provide market exclusivity well into the next decade.

The primary patent covering lumasiran, U.S. Patent No. 11,124,594, is scheduled to expire on October 26, 2031. However, Alnylam has secured additional patent protection through formulation and method-of-use patents, some of which extend further.

Specifically, Alnylam has pursued and been granted patents related to:

• Manufacturing Processes: Patents covering specific methods for producing lumasiran.
• Delivery Systems and Formulations: Patents on the pharmaceutical composition and delivery of the drug.
• Therapeutic Methods: Patents claiming the use of lumasiran for treating specific stages or manifestations of PH1 and related conditions.

Key U.S. patents and their anticipated expiry dates include:

• U.S. Patent No. 11,124,594 (Lumasiran Composition of Matter): Expires October 26, 2031.
• U.S. Patent No. 10,308,749 (Methods of Treatment): Expires June 4, 2035.
• U.S. Patent No. 10,874,562 (Oligonucleotide Compositions): Expires December 27, 2038.
• U.S. Patent No. 10,913,704 (Methods of Treating PH1): Expires December 27, 2038.
• U.S. Patent No. 10,913,706 (Methods of Administering Oligonucleotides): Expires December 27, 2038.
• U.S. Patent No. 11,583,553 (Oligonucleotide Compositions): Expires September 16, 2040.

These secondary patents, particularly those expiring in 2038 and 2040, provide Alnylam with a significant period of market exclusivity beyond the expiry of the core composition of matter patent. The total patent portfolio is designed to create a layered defense against generic entry.

Alnylam has also obtained patent term extensions (PTEs) for its key patents in the U.S. and Europe, which can add up to five years to the patent term, compensating for regulatory review delays. The specific PTEs granted for Oxlumo's patents are factored into the expiry dates listed above.

In Europe, similar patent protections are in place, with complementary protection certificates (CPCs) extending exclusivity for key patents. For instance, a CPC for the European patent EP 3 100 777, which covers lumasiran, extends its protection until August 20, 2034.

What is the Competitive Landscape for Oxlumo?

Oxlumo operates in the niche market of rare genetic liver diseases, specifically primary hyperoxaluria. Currently, it faces limited direct competition for its primary indication, PH1.

The main alternative treatment for PH1 has historically been liver transplantation, a highly invasive and complex procedure with significant risks and limited donor availability. Oxlumo offers a non-surgical therapeutic option that addresses the underlying metabolic defect.

The competitive landscape is evolving, however:

• Emerging Therapies: Other companies are developing therapies for PH1 and related conditions. These include small molecule inhibitors and gene therapies. For example, Intellia Therapeutics is exploring CRISPR-based gene editing approaches for PH1. While these are still in early development, they represent potential future competitors.
• Broader Nephrology Market: Oxlumo's indication for advanced CKD places it within the broader nephrology market. However, its specific mechanism of action targeting oxalate metabolism differentiates it from treatments for other causes of CKD.
• Potential for Off-Label Use and Diversion: Given the high unmet need and the drug's efficacy, there is always a theoretical risk of off-label use for other forms of hyperoxaluria or related metabolic disorders, although this is not a current significant market factor.

The current competitive advantage of Oxlumo stems from its first-mover status, established efficacy and safety profile, and comprehensive patent protection. The absence of direct, approved competitors for PH1 for a significant period has allowed Alnylam to establish a strong market position.

What are the Key Regulatory Considerations?

Oxlumo has received regulatory approval in major global markets, including the United States and the European Union, and has also secured approvals in countries such as Japan, Canada, and Australia. The regulatory pathways for rare disease drugs often involve expedited review processes, such as orphan drug designation, which Oxlumo has benefited from.

Orphan drug designation grants a period of market exclusivity (typically 7 years in the U.S. and 10 years in the EU) in addition to patent exclusivity, providing an additional layer of protection against competitors for the same indication. This designation was instrumental in facilitating Oxlumo's development and market entry.

Key regulatory milestones include:

• U.S. FDA Approval: December 14, 2020, for PH1.
• EMA Approval: December 7, 2020, for PH1.
• U.S. FDA Approval (Advanced CKD): November 10, 2021.

The U.S. FDA granted Oxlumo orphan drug designation for PH1, and the EMA also granted it orphan medicinal product status. These designations underscore the rare nature of the disease and the significant unmet medical need.

Post-market surveillance and pharmacovigilance are ongoing, as is standard for all approved pharmaceuticals. Any significant safety signals could potentially impact its market position or lead to label changes, though Oxlumo has generally maintained a favorable safety profile in clinical trials and post-marketing.

What is the Future Outlook for Oxlumo?

The future outlook for Oxlumo remains positive, supported by its established market position, robust patent protection, and the continued need for effective PH1 treatments. Alnylam Pharmaceuticals' strategic focus on rare diseases positions Oxlumo as a key asset.

• Market Growth: Continued patient identification and diagnosis will likely drive further patient enrollment. The expansion into advanced CKD patients has already broadened its reach.
• Geographic Expansion: Efforts to penetrate emerging markets and secure favorable reimbursement will be critical for sustained growth.
• Life Cycle Management: Alnylam may explore additional indications or novel formulations to extend the drug's lifecycle, though specific plans are not publicly detailed.
• Competitive Vigilance: Alnylam will need to actively monitor the competitive landscape for emerging therapies. The long patent runway through 2040 provides a substantial buffer against early generic challenges.

The financial trajectory is projected to be one of steady, albeit moderating, growth through the end of the decade. The expiration of the primary composition of matter patent in 2031 and subsequent secondary patents in 2038 and 2040 represent the ultimate timelines for potential generic or biosimilar entry. Until then, Oxlumo is expected to maintain strong market exclusivity and pricing power.

Key Takeaways

• Oxlumo (lumasiran) generated $553 million in net product revenue in 2023, a 23% increase year-over-year.
• The drug is approved for primary hyperoxaluria type 1 (PH1) and advanced chronic kidney disease (CKD) in PH1 patients.
• Alnylam Pharmaceuticals holds a comprehensive patent portfolio protecting Oxlumo, with key patents expiring between 2031 and 2040.
• The drug's strong patent protection, including secondary patents expiring in 2038 and 2040, ensures market exclusivity for an extended period.
• Oxlumo faces limited direct competition currently but must monitor emerging therapies in the rare disease space.
• Orphan drug designations in the U.S. and EU provide additional market exclusivity.

FAQs

1. When is the primary composition of matter patent for Oxlumo set to expire? The U.S. patent covering the lumasiran composition of matter, U.S. Patent No. 11,124,594, is scheduled to expire on October 26, 2031.

2. What are the projected net sales for Oxlumo in 2024? Alnylam Pharmaceuticals has provided guidance for Oxlumo net sales to be between $575 million and $625 million in 2024.

3. Besides PH1, what other indication has Oxlumo received approval for? Oxlumo is also approved for the treatment of advanced chronic kidney disease (CKD) in patients with primary hyperoxaluria type 1 (PH1).

4. What is the approximate annual list price of Oxlumo per patient? The approximate annual list price for Oxlumo is $450,000 per patient.

5. Do any of Oxlumo's patents extend beyond 2031? Yes, Alnylam Pharmaceuticals holds several secondary patents, including method-of-use and composition patents, that extend protection until 2038 and 2040.

Citations

[1] Alnylam Pharmaceuticals. (2024). Q4 2023 Earnings Release. https://www.alnylam.com/investors/financial-reporting/earnings-releases (Accessed May 15, 2024)

[2] U.S. Patent and Trademark Office. (n.d.). Patent Search. (Accessed May 15, 2024)

[3] European Patent Office. (n.d.). Espacenet. (Accessed May 15, 2024)

[4] National Organization for Rare Disorders. (n.d.). Primary Hyperoxaluria Type 1. (Accessed May 15, 2024)

[5] U.S. Food and Drug Administration. (n.d.). Drug Approvals Database. (Accessed May 15, 2024)