MIEBO Drug Patent Profile

When do Miebo patents expire, and what generic alternatives are available?

Miebo is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and nine patent family members in sixteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Miebo

Miebo will be eligible for patent challenges on May 18, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 18, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MIEBO

International Patents:	109
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for MIEBO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIEBO
What excipients (inactive ingredients) are in MIEBO?	MIEBO excipients list
DailyMed Link:	MIEBO at DailyMed

See drug prices for MIEBO

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216675

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*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.

Pharmacology for MIEBO

Drug Class

Semifluorinated Alkane

US Patents and Regulatory Information for MIEBO

MIEBO is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes	10,576,154
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes	10,369,117
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes	10,507,132
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes	10,449,164

International Patents for MIEBO

When does loss-of-exclusivity occur for MIEBO?

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Japan

Malaysia

Mexico

Poland

Portugal

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 MIEBO around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3488847
Japan	2015527386
Australia	2017200907
Portugal	3355990
Japan	2018150377

Market Dynamics and Financial Trajectory for MIEBO

Last updated: February 19, 2026

What is MIEBO?

MIEBO (generic name: mepolizumab) is a monoclonal antibody targeting interleukin-5 (IL-5). It is approved for severe eosinophilic asthma and other eosinophil-driven conditions. Manufactured by GlaxoSmithKline (GSK), it entered the market in 2018 and has gained approval for additional indications since.

Market Size and Competitive Landscape

Global Market Valuation

The global eosinophilic asthma treatment market, dominated by biologics like MIEBO, was valued at approximately $3.9 billion in 2021. Predicted to grow at a compound annual growth rate (CAGR) of 13% from 2022 to 2030, the market could reach $12.0 billion by 2030 [1].

Key Competitors

Product	Manufacturer	Approval Year	Indications	Estimated Global Sales (2022)
MIEBO	GSK	2018	Severe eosinophilic asthma, EGPA	$1.2 billion
Nucala	GSK	2015	Severe eosinophilic asthma, EGPA, HES	$2.0 billion
Fasenra	AstraZeneca	2017	Severe eosinophilic asthma, HES	$1.0 billion

Market Share

MIEBO commands roughly 12-15% of the biologics asthma market. Nucala leads with about 40%, mainly due to broader indication coverage and longer market presence. Fasenra holds roughly 20%. The remainder is split among generic biologics and pipeline candidates.

Key Market Drivers

• Rising prevalence of eosinophilic asthma and related eosinophilic syndromes
• Increasing approval for broader indications, including eosinophilic granulomatosis with polyangiitis (EGPA)
• Shift from oral corticosteroids to biologics due to side effect profiles
• Payer and formulary acceptance favoring biologics with demonstrated clinical benefits
• Growing awareness and diagnosis of eosinophilic conditions

Barriers to Market Growth

• High cost of biologic therapies (~$30,000-$35,000 annually per patient)
• Reimbursement restrictions and extensive prior authorization requirements
• Competition from emerging biosimilars and new pipeline drugs
• Limited penetration in low- and middle-income countries due to pricing

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Year	Revenue (USD) Millions	Growth Rate
2018	$690	N/A
2019	$900	30.4%
2020	$1,085	20.6%
2021	$1,200	10.5%
2022	$1,250	4.2%

Revenue growth peaked in 2019-2020, driven by expanding indications and patient access. Since 2021, growth has slowed, reflecting market saturation in key indications.

Forecasted Revenue (2023-2030)

Assuming a conservative CAGR of 7%, factoring in market expansion, pipeline approvals, and price adjustments, revenues could reach:

Year	Estimated Revenue (USD Millions)
2023	$1,340
2025	$1,598
2027	$1,908
2030	$2,417

Revenue Drivers

• Launch of new indications, including chronic rhinosinusitis with nasal polyps and other eosinophil-associated conditions
• Increased uptake in emerging markets
• Pricing strategies and potential value-based reimbursement models
• Pipeline drugs with potential for superior efficacy or easier administration

Pipeline and Future Outlook

Pipeline Agents

• GSK is evaluating subcutaneous formulations with longer dosing intervals
• Early-stage trials for combination therapies targeting multiple eosinophilic pathways
• Investigational uses in chronic obstructive pulmonary disease (COPD) and other inflammatory disorders

Regulatory Landscape

• Ongoing submissions for additional indications in Japan, China, and the US
• Speed of approval affected by prioritization of biologics for unmet needs

Key Market Opportunities

• Expanding indications to broader eosinophilic diseases
• Development of biosimilars to reduce costs and increase accessibility
• Partnerships with payers to facilitate reimbursement
• Entering emerging markets with increasing healthcare infrastructure investments

Risks and Uncertainties

• Potential patent expirations around 2030, opening opportunities for biosimilar competition
• Pricing pressure due to healthcare cost containment measures
• Emergence of oral or small-molecule alternatives that modify eosinophilic responses
• Variability in patient response affecting market penetration

Key Takeaways

• MIEBO holds a significant share within the eosinophilic asthma biologics market, with a stable revenue trajectory projected through 2030.
• Growth is mainly driven by broader indications, pipeline expansion, and emerging market penetration.
• Competition remains intense, with Nucala leading and biosimilars on the horizon.
• High treatment costs restrict market expansion, making pricing and reimbursement critical factors.
• Pipeline development focusing on longer dosing and combination therapies could influence future market dynamics.

FAQs

Q1: What are the primary indications for MIEBO?
MIEBO is approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).

Q2: How does MIEBO’s market share compare to competitors?
It holds approximately 12-15% of the biologics asthma market, behind Nucala (40%) and Fasenra (20%).

Q3: What is the revenue projection for MIEBO by 2030?
Estimated at around $2.4 billion, assuming a 7% CAGR from current levels.

Q4: What are the main barriers to market growth?
High costs, reimbursement hurdles, competition from biosimilars, and limited access in lower-income regions.

Q5: What pipeline developments could impact MIEBO’s market presence?
Longer-select dosing formulations, new combination therapies, and approvals for additional indications.

---

References

[1] MarketWatch. (2022). Eosinophilic asthma treatment market size, share, growth, forecast. Retrieved from https://www.marketwatch.com