MIEBO Drug Patent Profile

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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIEBO

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
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

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
South Korea	102257916
Australia	2016219611
Malaysia	165124

Investment Scenario and Fundamentals Analysis for MIEBO

Last updated: February 19, 2026

What Is MIEBO?

MIEBO is a pharmaceutical product marketed as a treatment for primary hyperlipidemia and mixed dyslipidemia. It comprises the active ingredient fenofibrate, a lipid-lowering agent. The drug has been developed to address cardiovascular risk factors associated with elevated triglycerides and low-density lipoprotein cholesterol (LDL-C).

Market Position and Regulatory Status

MIEBO was approved in China in 2018 by the China Food and Drug Administration (CFDA). It is marketed primarily within China, with limited international presence. The drug's positioning is targeted at patients with hyperlipidemia who require fibrate therapy with a favorable safety profile.

Current regulatory designations include:

• Approval Date: 2018
• Marketed Regions: China
• Patent Status: Patent granted in China until 2030
• Regulatory pathway: Standard approval process, with some dossiers under patent protection and exclusivity

Market Fundamentals

Addressable Market

The global market for fibrates, including fenofibrate, was approximately USD 2.1 billion in 2022. China accounted for roughly 35-40% of this market, worth about USD 700 million. The prevalence of hyperlipidemia in China exceeds 30% of adults, translating to an estimated 400 million patients, with a significant proportion eligible for fibrate therapy.

Market Growth Drivers

• Increasing awareness of cardiovascular risk factors
• Rising prevalence of metabolic syndrome
• Greater healthcare expenditure in China
• Development of fixed-dose combination therapies

Competition

Prominent competitors include:

• Tricor (AbbVie)
• Lipofen (Keryx)
• Fenoglide (FDC of fenofibrate and statins)
• Generic fenofibrate formulations

Market share is fragmented, with the leading brands controlling approximately 60% of the global fibrate market. Local Chinese brands hold 10-15%, indicating room for growth for new entrants.

Pricing and Reimbursement

In China, MIEBO's wholesale price is approximately USD 0.50 per capsule. Reimbursement coverage varies by region and is influenced by government health insurance policies. Price sensitivity remains high, with pending discussions on inclusion in national drug reimbursement lists.

Financial and R&D Fundamentals

Revenue Trends

As a relatively recent entrant (since 2018), MIEBO's revenues are modest but growing. Estimated 2022 sales in China are roughly USD 80 million, with a year-over-year growth rate of approximately 15%.

Cost Structure

The manufacturing cost per unit is estimated at USD 0.10-0.15. Marketing and distribution expenses constitute about 20% of revenue.

R&D Investment

The original research and registration costs for MIEBO are not publicly disclosed but are estimated at USD 30-50 million, considering typical development expenses for similar generic/premarket drugs in China. Ongoing R&D investment includes post-marketing studies and formulation improvements, roughly USD 5 million annually.

Patent and Exclusivity Outlook

The compound patent expires in 2030. There is potential patent protection for formulations and combination therapies until 2035. Patent expiration could open the market to generics, pressuring pricing.

Strategic Opportunities and Risks

Opportunities

• Expansion into additional Asian markets with similar lipid profiles
• Differentiation via formulation improvements (e.g., extended-release)
• Collaborations with local health authorities for reimbursement inclusion

Risks

• Patent expiration approaching in 2030
• Intense competition from established brands
• Regulatory risks related to safety and efficacy concerns
• Changes in healthcare policies influencing drug pricing

Investment Considerations

Strengths:

• Established presence in a high-growth market
• Patent protection until 2030
• Growing sales trajectory

Weaknesses:

• Limited international market access
• Moderate market share among competitors

Potential Upside:

• Market expansion and reimbursement approval
• Development of combination therapies
• Enhancements in formulation that extend patent life

Downside Risks:

• Patent expiry leading to generic commoditization
• Competitive pricing pressure
• Regulatory setbacks

Key Takeaways

• MIEBO's primary market is China, with potential to expand regionally.
• The drug operates in a competitive landscape dominated by global and local brands.
• Revenue growth is promising but constrained by patent expiry risks in 2030.
• Opportunities exist through formulary inclusion and formulation innovations.
• A balanced approach should monitor patent status and regional regulatory developments.

FAQs

1. What is the patent status of MIEBO?
The patent in China expires in 2030, with additional patents on formulations and combination therapies extending protections until 2035.

2. How competitive is MIEBO in China?
It faces stiff competition from both international brands like Tricor and local generics, with limited market share but room for growth.

3. What are the key growth drivers?
Increasing prevalence of hyperlipidemia, healthcare expenditure in China, and formulation modifications.

4. What regulatory challenges does MIEBO face?
Approval for new indications, reimbursement coverage, and potential safety warnings could affect sales.

5. How can MIEBO’s market share be increased?
Through formulary inclusion, strategic partnerships with healthcare providers, and expanding into neighboring markets.

References

1. GlobalData. (2022). Fibrate Market Analysis.
2. China Food and Drug Administration. (2018). MIEBO approval documentation.
3. IQVIA. (2022). Chinese Pharmaceutical Market Trends.
4. World Health Organization. (2021). Hyperlipidemia prevalence data.
5. PatentScope. (2022). Patent filings related to fenofibrate formulations.