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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 seven 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:	107
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information 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.

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
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes	11,357,738		Y

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	20150054996
Canada	2883003	COMPOSITIONS D'ALCANES SEMIFLUORES (SEMIFLUORINATED ALKANE COMPOSITIONS)
Mexico	363182	COMPOSICIONES QUE COMPRENDEN MEZCLAS DE ALCANOS SEMIFLUORADOS. (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES.)
Japan	6640919
Japan	2018111704	半フッ化アルカンの混合物を含む組成物 (COMPOSITION CONTAINING MIXTURE OF SEMI-FLUORIDATED ALKANE)
China	104755073

MIEBO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MIEBO

Introduction to MIEBO

MIEBO, also known as perfluorohexyloctane ophthalmic solution (formerly NOV03), is a groundbreaking treatment for dry eye disease (DED) that has recently gained significant attention in the eye health industry. Approved by the U.S. Food and Drug Administration (FDA) in May 2023, MIEBO is the first and only FDA-approved treatment that directly targets tear evaporation, a key factor in DED[1][5].

Market Context of Dry Eye Syndrome

The global dry eye syndrome treatment market is experiencing robust growth, valued at $4.7 billion in 2022 and projected to reach $9.3 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.1%[1]. This growth is driven by increasing prevalence, higher patient awareness, and the introduction of innovative treatments like MIEBO.

Competitive Landscape

In the DED market, MIEBO competes with other notable treatments such as Xiidra, Restasis, and Cequa. However, MIEBO's unique mechanism of action, targeting tear evaporation, sets it apart from existing treatments. While previous generations of DED treatments have had limitations due to side effects and modest symptom improvement, MIEBO's launch has been met with positive feedback from eye care professionals[2][3].

Bausch + Lomb's Strategic Positioning

Bausch + Lomb, the company behind MIEBO, has made significant strategic moves to strengthen its position in the DED market. The acquisition of Xiidra from Novartis in 2023, along with the approval of MIEBO, has expanded Bausch + Lomb's portfolio in ocular surface diseases. This acquisition is expected to accelerate margin expansion and provide immediate earnings accretion[5].

Financial Performance and Projections

The financial trajectory for MIEBO looks promising. In the Q4 2023 earnings call, Bausch + Lomb reported that MIEBO's launch had been the strongest in recent years for DED treatments. For 2024, MIEBO is expected to contribute approximately $95 million in revenue, with positive momentum anticipated to continue[3].

Revenue Potential

The total addressable market (TAM) for DED treatments is substantial, estimated at around $20 billion. With MIEBO targeting a unique aspect of DED, it has the potential to capture a significant share of this market. The success of previous DED drugs, such as Restasis, which exceeded $1.4 billion in revenue before going off patent, highlights the revenue potential for effective DED treatments[2].

Insurance and Market Access

Despite the promising market dynamics, the insurance landscape presents a challenge. Insurance companies often prefer cheaper, older drugs, requiring patients to fail on these before trying new treatments. However, given the large pool of patients who have already failed on older treatments, there is a significant opportunity for MIEBO to gain traction[2].

Regional Market Growth

The global dry eye syndrome market is expected to grow significantly, with different regions contributing at varying rates. North America is currently the largest regional market, while the Asia Pacific region is expected to grow with the highest CAGR during the forecast period due to higher patient preference for over-the-counter (OTC) drugs and new drug launches[1][4].

Industry Expert Insights

Brent Saunders, Chairman and CEO of Bausch + Lomb, emphasized the strategic importance of the Xiidra acquisition and the approval of MIEBO, stating that these moves transform the company's pharmaceuticals business and position it as a leader in ocular surface diseases[5].

Challenges and Opportunities

While MIEBO's launch has been successful, Bausch + Lomb faces challenges such as managing the performance of Xiidra, which has seen declining revenue, and navigating the competitive landscape. However, the potential of MIEBO and the vast DED market offer significant upside, making the future of Bausch + Lomb dependent on its ability to capitalize on these opportunities[2][3].

Conclusion on Market Dynamics

MIEBO's entry into the DED market marks a significant shift in treatment options, offering a unique solution that targets tear evaporation. With strong financial projections, a growing market, and strategic positioning by Bausch + Lomb, MIEBO is poised to become a key player in the dry eye syndrome treatment market.

Key Takeaways

• Market Growth: The global dry eye syndrome treatment market is projected to grow from $4.7 billion in 2022 to $9.3 billion by 2032.
• Unique Mechanism: MIEBO is the first FDA-approved treatment that directly targets tear evaporation.
• Financial Projections: MIEBO is expected to contribute approximately $95 million in revenue for 2024.
• Strategic Acquisitions: Bausch + Lomb's acquisition of Xiidra and the approval of MIEBO strengthen its position in the DED market.
• Regional Growth: North America is the largest regional market, while the Asia Pacific region is expected to grow with the highest CAGR.
• Challenges and Opportunities: Managing Xiidra's performance and navigating the competitive landscape are key challenges, but MIEBO's potential offers significant upside.

FAQs

Q: What is MIEBO and how does it differ from other DED treatments?

MIEBO, or perfluorohexyloctane ophthalmic solution, is the first FDA-approved treatment that directly targets tear evaporation, a key factor in dry eye disease. This sets it apart from other treatments like Xiidra and Restasis.

Q: What is the current market size and growth projection for the dry eye syndrome treatment market?

The global dry eye syndrome treatment market was valued at $4.7 billion in 2022 and is projected to reach $9.3 billion by 2032, growing at a CAGR of 7.1%[1].

Q: How much revenue is MIEBO expected to generate in 2024?

MIEBO is expected to contribute approximately $95 million in revenue for 2024[3].

Q: What are the key challenges faced by Bausch + Lomb in the DED market?

Bausch + Lomb faces challenges such as managing the declining revenue of Xiidra and navigating the competitive landscape, but the potential of MIEBO offers significant upside[2][3].

Q: Which region is expected to grow with the highest CAGR in the dry eye syndrome market?

The Asia Pacific region is expected to grow with the highest CAGR during the forecast period due to higher patient preference for OTC drugs and new drug launches[4].

Sources

1. Allied Market Research - Dry Eye Syndrome Treatment Market Statistics | Forecast - 2032
2. Seeking Alpha - Bausch+Lomb's Xiidra Acquisition Is Questionable, But Miebo Could ...
3. Alpha Spread - BLCO Q4-2023 Earnings Call
4. Fortune Business Insights - Dry Eye Syndrome Market Size, Share, Growth | Forecast [2032]
5. Ophthalmology Times Europe - Bausch + Lomb announces acquisition of Xiidra from Novartis