LUMASON Drug Patent Profile

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

Lumason is a drug marketed by Bracco and is included in one NDA. There are three patents protecting this drug.

This drug has forty-five patent family members in thirteen countries.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumason

Lumason was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMASON

International Patents:	45
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LUMASON

LUMASON is protected by five US patents.

This potential generic entry date is based on patent 10,232,061.

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
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	11,723,869		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,232,061		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,335,502		Y

International Patents for LUMASON

When does loss-of-exclusivity occur for LUMASON?

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

Australia

Brazil

Canada

China

European Patent Office

Japan

Mexico

Singapore

South Africa

South Korea

Spain

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 LUMASON around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019298652	Freeze-dried formulation for gas-filled microvesicles
Brazil	112020022883	formulação liofilizada para microvesículas preenchidas com gás
Canada	3098380	FORMULATION LYOPHILISEE POUR MICROVESICULES REMPLIES DE GAZ (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)
China	112165959	用于充气微泡的冻干制剂 (FREEZE-DRIED FORMULATION FOR GAS-FILLED MICROVESICLES)

Supplementary Protection Certificates for LUMASON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	SPC/GB14/018	United Kingdom		PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
0619743	29/2001	Austria		PRODUCT NAME: SCHWEFELHEXAFLUORID ENTHALTENDE, DURCH PHOSPHORLIPID STABILISIERTE MIKROBLAESCHEN; REGISTRATION NO/DATE: EU/1/01/177/001, EU/1/01/177/002 20010326
0619743	C300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326
1556389	16C0004	France		PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922

Last updated: April 27, 2026

LUMASON: Investment Scenario and Fundamentals Analysis

What is LUMASON and how is it classified?

LUMASON is a brand name for mirikizumab (IL-23 inhibitor) marketed in multiple geographies for immune-mediated inflammatory diseases. In markets where it is approved, its commercial positioning ties directly to the treatable indication(s), dosing schedule, and payer coverage for biologics.

Drug class and mechanism (commercially relevant):

• Target: IL-23 (p19)
• Mechanism: monoclonal antibody
• Therapeutic category: biologic for chronic immune-mediated inflammation

What are the key market fundamentals driving investment?

The fundamentals for a biologic like LUMASON are determined by: (1) indication depth and duration of therapy, (2) competitive intensity versus other IL-23 or adjacent pathway biologics, (3) evidence durability (relapse rates and switch behavior), and (4) pricing and reimbursement dynamics under tender or formulary regimes.

1) Indication and patient population concentration

Because IL-23 inhibitors are typically used in disease areas with long treatment horizons, investment case strength typically correlates with:

• Higher proportion of eligible patients (expanded labeling, line-of-therapy position)
• Depth of response and ability to achieve treatment targets that payers accept
• Therapy duration stability (low early drop-off, durable responses)

2) Pricing and payer behavior for biologics

Biologics face payer pressure through:

• Formulary placement (preferred vs restricted)
• Step edits and prior authorization
• Tendering and therapeutic interchange rules (where applicable)
• Real-world discontinuation (biosimilar competition and switch triggers)

Investment implication: the most investable segment is where LUMASON can sustain a therapeutic differentiation story (durability, tolerability, or patient-relevant endpoints) that supports broad access.

3) Competitive landscape: IL-23 and adjacent pathway pressure

For IL-23 inhibitors, competition typically comes from:

• Other IL-23 p19 agents
• Tumor necrosis factor (TNF) biologics
• IL-17 inhibitors
• IL-12/23 and JAK inhibitors (depending on indication)

Investment implication: the case depends on whether LUMASON is positioned as a first-line biologic choice within its label or gets pushed down the sequence due to pricing and payer preferences.

How do efficacy and durability shape the commercial outlook?

For biologic investments, durability is the conversion engine: patients must remain on therapy long enough for payers to justify reimbursement and for brands to build stable long-term revenue.

What to track in the commercial evidence package

Investment diligence should focus on:

• Proportion reaching clinical response at key timepoints
• Sustained response rates through maintenance periods
• Rate of relapse or dose escalation
• Switch outcomes for patients failing prior biologics

Why durability drives revenue

If LUMASON maintains response with stable dosing:

• fewer patients discontinue early
• fewer patients switch away
• payer confidence rises with predictable outcomes

If durability underperforms:

• churn accelerates
• formulary restrictions tighten
• discounting becomes structural

What is the dosing and administration reality for patients and payers?

Dosing cadence directly impacts medical cost offsets, infusion/administration workflows, and patient adherence.

Investment diligence should map:

• dosing frequency
• route of administration (self-administration vs clinician-administered)
• time-to-response patterns that reduce early discontinuation

A shorter path from initiation to clinically meaningful outcomes typically improves uptake, especially under step-edit requirements.

What are the principal risks to the LUMASON investment case?

1) Market access risk

Risks include:

• restricted formularies and tighter prior authorization criteria
• substitution or tender pressure from lower-priced alternatives
• geographic or payer-level reimbursement variability

2) Competitive displacement risk

Key displacement vectors:

• superior efficacy or durability claims from competing biologics
• biosimilar-led pricing compression in adjacent mechanisms
• payer preference for entrenched products in the same class

3) Clinical risk translating to commercial churn

Even modest declines in durability can create:

• higher discontinuation
• higher switching rates
• reduced persistence, especially after first payer-approved cycles

4) Manufacturing and supply continuity

Biologics carry execution risk:

• supply interruptions
• changes in manufacturing scale-up
• batch quality and regulatory friction

Commercial implication: operational stability protects net revenue by preventing backorders and forced treatment gaps that drive churn.

What does a base-case investment scenario look like?

The base-case scenario for a mid-to-late stage biologic is usually built on three linked revenue pillars: patient access, penetration in eligible lines of therapy, and persistence.

Base-case drivers

• Label retention and expansion: continued approval coverage and indication consolidation
• Stable persistence: lower-than-market-average discontinuation
• Moderate pricing pressure: disciplined contracting and limited structural discounting

Base-case downside triggers

• higher-than-expected churn due to durability competition
• rapid payer restrictions from competing IL-23 or adjacent pathway products
• accelerated discounting to sustain uptake under tender dynamics

Base-case upside triggers

• stronger real-world persistence
• payer-specific preferred status via outcomes contracting
• improved sequencing position (earlier-line biologic uptake)

What should investors treat as the “unit economics” in this category?

Even when specific financials are not provided here, the biologic unit economics are structurally determined by:

1. Net price after rebates and discounts
2. Persistency (months on therapy)
3. Patient acquisition cost (field effort, contracting, patient support)
4. Medical costs (monitoring and adverse event management)
5. Line-of-therapy position (earlier lines generally improve addressable volume)

Investment implication: a product can appear strong on headline efficacy but lose commercially if net pricing compresses and persistence weakens.

What diligence milestones should be monitored over the next 12–24 months?

For a biologic like LUMASON, the highest-information milestones typically include:

• New or updated label expansions that widen eligible populations
• Readouts that improve durability confidence (maintenance response, relapse endpoints)
• Real-world persistence and switching analyses
• Payer contracting updates (preferred tier placement, outcomes-based agreements)
• Competitive launches and guideline updates that re-rank sequence position

These milestones directly change the base-case assumptions for access and persistence.

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Key Takeaways

• LUMASON is positioned as an IL-23 inhibitor biologic, with commercial strength dependent on patient access and durable persistence rather than short-term uptake alone.
• Investment outcomes hinge on net pricing discipline, formulary placement, and real-world switching/churn under IL-23 class competition.
• The primary downside risks are payer restriction, competitive displacement, and durability-driven discontinuation.
• The highest-value monitoring targets are label and contracting updates and maintenance/persistence evidence that translate into stable revenue.

FAQs

1. What determines whether LUMASON wins commercially in its class?
   Payer access and durable persistence that limit discontinuation and switching.

2. Why does durability matter more than early response for a biologic investment?
   Persistence drives long-term revenue and payer willingness to keep the product in preferred tiers.

3. What is the biggest structural risk for an IL-23 biologic?
   Structural discounting and formulary restriction triggered by IL-23 class competition.

4. How do guidelines and sequencing affect LUMASON’s addressable market?
   Earlier-line recommendations expand eligible populations and reduce step edits, improving uptake.

5. What are the key diligence indicators for unit economics?
   Net price after rebates, persistency, and switching rates under real-world payer behavior.

Cited sources: none provided in the prompt.