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 two hundred and one 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:	201
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

Constraining patent/regulatory exclusivity:

11,446,380

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.

This potential generic entry date is based on patent 11,446,380.

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	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

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
Australia	2008242583
Canada	2685127
World Intellectual Property Organization (WIPO)	2008131419
Australia	2014369850
Australia	2021201953
Canada	2935220

Supplementary Protection Certificates for OXLUMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3581654	LUC00218	Luxembourg		PRODUCT NAME: LUMASIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1496 20201123
3581654	PA2021008	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/1/20/1496 20201119
3581654	301132	Netherlands		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201123
3581654	2021C/534	Belgium		PRODUCT NAME: LUMASIRAN; AUTHORISATION NUMBER AND DATE: EU1/20/1496 20201123
3581654	CA 2021 00038	Denmark		PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201123
3581654	122021000053	Germany		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201119

Last updated: June 26, 2026

OXLUMO (lumasiran) Market Dynamics and Financial Trajectory: Sales, Growth Drivers, Competition, and IP/Exclusivity Risks

OXLUMO (lumasiran) is a commercial-stage, single-agent therapy for primary hyperoxaluria type 1 (PH1). Market dynamics are shaped by (1) PH1 diagnosis and referral patterns, (2) payer approvals and prior authorization behavior, (3) uptake in pediatric versus adult segments, and (4) the speed and credibility of competitive alternatives. Financial trajectory is primarily a function of treated-patient penetration per region, dosing intensity under label-based use, and the timeline risk posed by exclusivity cliffs tied to patent term and regulatory exclusivities.

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What is OXLUMO (lumasiran) used for, and what does the label imply for dosing and unit economics?

Primary indication: OXLUMO (lumasiran) is indicated for treatment of primary hyperoxaluria type 1 (PH1) to reduce urinary oxalate production and related disease burden. (FDA label)

Core commercial implication: unit sales and long-run revenue durability are tied to how quickly PH1 patients move from diagnosis to treatment and how consistently payers approve ongoing dosing.

Pediatric vs adult uptake: why it matters to revenue ramp

PH1 management differs by age distribution and disease severity, which affects treatment initiation rates.

• Pediatric initiation is often triggered by early symptomatic disease, high referral intensity at metabolic centers, and ongoing monitoring protocols.
• Adult initiation can be slower due to diagnostic delays and more frequent confounding etiologies, which tends to compress early market share growth.

Dosing pattern: what drives “cost per treated patient”

Revenue scaling for lumasiran depends on the number of administrations per patient over time and persistence (continuing treatment versus discontinuation). Commercial models typically price per dosing cycle and forecast patient counts at each stage of the treatment journey.

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How big is the PH1 addressable market for lumasiran, and what determines treatable patients?

Featured-snippet answer: The addressable market for OXLUMO tracks the number of diagnosed PH1 patients who are managed at centers able to initiate and maintain therapy, not the total PH1 prevalence alone.

Key demand-side gates:

1. Diagnosis rate: fraction of PH1 patients correctly identified as PH1 and typed as type 1.
2. Treatment eligibility: physician confirmation, biomarker thresholds, and guideline alignment.
3. Access: payer coverage, step edits, and patient support program effectiveness.
4. Geographic coverage: reimbursement and availability through specialty distribution channels.

Market sizing sensitivity

Commercial outcomes vary sharply based on:

• whether payers require prior authorization with specialist notes and confirmatory genetic testing
• whether plan formularies treat lumasiran as preferred or nonpreferred in rare disease tiers
• how quickly national rare-disease networks build PH1 referral pipelines

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What market dynamics are driving OXLUMO sales growth (or slowing) by region and payer segment?

Featured-snippet answer: OXLUMO’s growth is driven by referral center penetration and payer approval velocity, moderated by rare-disease contracting and formulary placement.

Coverage and payer behavior

For ultra-rare drugs, payer dynamics often determine early trajectory more than clinical adoption speed.

Common drivers of commercial lift:

• inclusion in high-acuity rare disease pathways
• managed entry agreements or outcomes-based contracting (where used)
• consistent authorization criteria across regional managed care organizations

Common drivers of commercial friction:

• narrow clinical-criteria documentation requirements
• delays in prior authorization cycles
• patient-level exceptions that increase support costs

Specialty channel mechanics

• distribution is generally routed through specialty pharmacies and limited distribution hubs
• inventory and cold-chain logistics can influence fulfillment timing and revenue recognition cadence

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When does OXLUMO face exclusivity cliffs, and how do they affect the financial trajectory?

Featured-snippet answer: The trajectory is most exposed around the overlap of (1) patent term expiry for composition and method coverage and (2) any regulatory exclusivity that delays generic or biosimilar-like competition for the relevant product class.

Because OXLUMO is a small-molecule? (It is an RNA interference therapeutic delivered via siRNA chemistry, but the regulatory and exclusivity framework depends on the exact approval history and listed exclusivities.) This analysis cannot be completed accurately without OXLUMO’s FDA exclusivity and Orange Book patent list details.

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What patents protect OXLUMO (lumasiran), and how strong is the patent estate versus generic or competitor entry?

Featured-snippet answer: Patent strength for OXLUMO hinges on whether key patents cover composition (lumasiran), delivery/chemistry, and method-of-use for PH1, plus whether claim scopes are robust enough to withstand generic “carve-out” design-around.

No complete, accurate patent-estate mapping is provided here because the required Orange Book listing set (assignee, publication, grant/expiry, and claim scope) and any litigation assignments are not included in the input.

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What is the Orange Book status of OXLUMO, and are there any Paragraph IV or other generic-approval signals?

Featured-snippet answer: The Orange Book status defines the practical entry window for any chemically identical ANDA product; Paragraph IV signals would appear as challenge notifications or litigation around those patents.

This section cannot be completed accurately without OXLUMO’s Orange Book patent listing records, listed FDA application identifiers, and any associated ANDA challenge documentation.

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What competitive threats exist for lumasiran, including pipeline alternatives and switch risk?

Featured-snippet answer: Competitive threats for OXLUMO are driven by the probability of other PH1 therapies achieving payers’ “clinical value” thresholds and gaining treatment share at metabolic centers.

Competition channels:

• Direct PH1 therapies seeking to reduce urinary oxalate and improve clinical endpoints
• Adjunct and bridging strategies (hyperoxaluria management) that may shift treatment patterns at initiation or during complications
• Geography-specific competitive positioning through pricing, contracting, and center-specific experience

A precise competitive risk ranking requires company-by-company pipeline and approved-therapy information for PH1 at lumasiran’s relevant geographies. That dataset is not included in the prompt.

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How does OXLUMO compare with competing PH1 therapies on efficacy endpoints that payers and centers prioritize?

Featured-snippet answer: Payers and centers typically prioritize endpoints linked to kidney stone burden, urinary oxalate reduction, renal function preservation markers, and reduction in disease progression proxies used in clinical practice.

This section cannot be completed accurately without the comparator therapy list, specific endpoints each therapy controls, and publicly reported comparative results.

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What OXLUMO litigation or settlement dynamics could affect timing of generic entry and revenue protection?

Featured-snippet answer: Litigation affects revenue protection when it targets key Orange Book patents and culminates in stay or settlement agreements that delay approval.

This section cannot be completed accurately without:

• the case caption(s)
• asserted patent numbers
• filing dates
• settlement terms (if any)
• court orders affecting timelines

No litigation identifiers are provided in the input.

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What is the FDA regulatory pathway history for OXLUMO, and how does it shape reimbursement and adoption?

Featured-snippet answer: OXLUMO’s regulatory designations (such as orphan and accelerated frameworks if applicable) influence early access, center comfort, and payer willingness to cover.

This section cannot be completed accurately because the regulatory history facts (approval year, designation list, priority review status, and label milestones) are not included in the prompt.

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Commercial trajectory: how should investors model OXLUMO revenue under base, bull, and bear adoption scenarios?

Modeling structure that maps to market mechanics

A workable revenue model for OXLUMO generally decomposes into:

1. Diagnosed PH1 patient pool (by geography)
2. Treatment penetration (share treated with lumasiran)
3. Dosing intensity and persistence (duration of therapy per patient)
4. Net pricing (list price minus rebates/discounts)
5. Timing effects (authorization delays, therapy start lag, quarter-to-quarter fulfillment)

Scenario framing

• Base case typically assumes gradual penetration growth through metabolic centers plus steady payer approvals.
• Bull case requires faster than expected conversion from diagnosis to treatment and broader payer inclusion.
• Bear case is associated with slower diagnosis conversion, narrow payer criteria enforcement, and/or loss of share to competing PH1 approaches.

A quantified forecast is not provided because no actual historical revenue series, pricing disclosures, or payer contract metrics are included in the prompt.

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What commercial milestones should track OXLUMO’s financial trajectory quarter to quarter?

Featured-snippet answer: The best leading indicators for lumasiran are treated-patient count growth, prescription/refill cadence through specialty channels, payer coverage expansion, and any incremental dosing guideline shifts that change persistence.

Leading indicators:

• new patient starts per period
• discontinuation rates (persistence)
• specialty pharmacy fill velocity
• payer coverage changes (formulary expansions, reduced prior auth friction)
• geographic expansion of access

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Key Takeaways

• OXLUMO’s financial trajectory depends more on diagnosis-to-treatment conversion, payer approval velocity, and persistence than on incremental label expansion.
• Market dynamics for PH1 are ultra-rare and payer-driven; contracting and prior authorization behavior can dominate near-term sales velocity.
• Exclusivity and patent estate timing are the primary revenue-protection variables, but an accurate exclusivity/patent risk assessment requires Orange Book and litigation facts that are not present in the prompt.
• Competitive threats depend on whether other PH1 therapies can win at metabolic centers and obtain favorable payer positioning, which is also information-dependent beyond the prompt.
• For investment and licensing decisions, revenue modeling should be built around diagnosed patient penetration, persistence, net pricing, and authorization timing.

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FAQs

1. How do rare-disease payers typically structure coverage for OXLUMO (lumasiran)?
2. What is the relationship between PH1 diagnosis rates and lumasiran treatment initiation in major markets?
3. How do prior authorization and specialty pharmacy fill patterns influence quarterly revenue recognition for OXLUMO?
4. What patent or exclusivity milestones most directly determine the timing of potential generic competition for lumasiran?
5. How should clinicians and investors evaluate persistence risk for long-term RNAi therapies like OXLUMO?

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References (APA)

1. U.S. Food and Drug Administration. OXLUMO (lumasiran) prescribing information. FDA label.