PERFLUOROHEXYLOCTANE - Generic Drug Details

What are the generic drug sources for perfluorohexyloctane and what is the scope of freedom to operate?

Perfluorohexyloctane is the generic ingredient in one branded drug marketed by Bausch And Lomb Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for PERFLUOROHEXYLOCTANE

International Patents:	109
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERFLUOROHEXYLOCTANE
What excipients (inactive ingredients) are in PERFLUOROHEXYLOCTANE?	PERFLUOROHEXYLOCTANE excipients list
DailyMed Link:	PERFLUOROHEXYLOCTANE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for PERFLUOROHEXYLOCTANE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch & Lomb Incorporated	PHASE3
Bausch & Lomb Incorporated	PHASE2
Bausch & Lomb Incorporated	PHASE4

See all PERFLUOROHEXYLOCTANE clinical trials

Pharmacology for PERFLUOROHEXYLOCTANE

Drug Class

Semifluorinated Alkane

US Patents and Regulatory Information for PERFLUOROHEXYLOCTANE

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

International Patents for PERFLUOROHEXYLOCTANE

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

PERFLUOROHEXYLOCTANE Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Perfluorohexyloctane?

Perfluorohexyloctane (PFHO) is a fluorinated hydrocarbon primarily developed for ophthalmic applications. It functions as a tear substitute and ocular lubricant. Its market is driven by several factors:

• Medical Need: Severe dry eye disease (DED) affects an estimated 5%–15% of the global population, creating demand for effective tear substitutes [1].

• Regulatory Approvals: PFHO's approval by regulatory agencies influences market penetration. For instance, its approval by the U.S. FDA as a medical device (Ogra) in 2020 established its availability in the U.S. market.

• Competitive Landscape: PFHO competes with existing eye lubricants, such as artificial tears, eyelid warming devices, and surgical interventions. Unlike traditional lubricants, PFHO's unique chemical composition offers longer-lasting relief.

• Manufacturing and Supply Chain: Limited production facilities specialized in fluorinated compounds slow supply growth, impacting market expansion potential.

• Geographical Penetration: North America and Europe dominate early adoption due to advanced healthcare infrastructure, with emerging markets in Asia-Pacific showing increasing interest.

How Is the Financial Trajectory Shaping?

Accurate sales data for PFHO remains proprietary; however, market analysts project the following trajectory based on available data:

Metric	2022 Estimate	2023 Projection	2025 Projection
Global Dry Eye Market Size	$4.5 billion	$5.1 billion	$6.7 billion
PFHO Market Share	<1%	2%	5%
Annual Revenue from PFHO	<$10 million	$20–30 million	$50–80 million

Note: Revenue figures are estimates based on market share and total dry eye market growth.

Revenue Drivers

• Regulatory Approvals: Facilitate commercialization; recent approvals in select countries expand market potential.

• Clinical Data: Positive trial outcomes increase prescriber confidence and adoption rates.

• Pricing Strategy: Premium pricing is common, reflecting the relatively novel technology and manufacturing costs of fluorinated compounds.

Challenges

• Market Penetration: The current low market share indicates slow uptake, constrained by competition and limited awareness.

• Manufacturing Costs: High costs associated with fluoropolymer synthesis influence pricing and profit margins.

• Long-Term Evidence: Insufficient long-term safety data may hinder broader acceptance.

What Are the Key Factors Affecting Future Market Growth?

• Development of new formulations demonstrating superior efficacy and safety.
• Expansion into additional indications, such as ocular surface diseases beyond dry eye.
• Strategic partnerships with ophthalmic device and pharmaceutical companies.
• Competitive responses from traditional lubricant manufacturers.

How Do Regulatory Policies Impact the Trajectory?

Regulatory reviews significantly impact market access. PFHO's FDA clearance as a medical device enabled commercialization in the U.S., but approvals in other territories can vary:

• European Union: CE marking process; no specific approval yet.
• Asia-Pacific: Countries like Japan and China have evolving regulations on fluorinated compounds, potentially delaying market entry.

What Is the Investment Outlook?

Given the slow initial market penetration but potential for expansion, PFHO presents moderate investment risk:

• Growth Potential: High if commercialization expands and new indications are approved.

• Risk Factors: Regulatory delays, manufacturing barriers, and competition from conventional lubricants.

Key Takeaways

• Perfluorohexyloctane addresses an unmet need in dry eye management with distinct chemical properties.
• Market size remains small but is projected to grow as regulatory approvals increase and awareness improves.
• Revenue growth hinges on clinical evidence, healthcare provider acceptance, and strategic market expansion.
• Manufacturing costs and regulatory timelines are primary barriers to rapid growth.
• The competitive landscape favors long-term adoption if PFHO demonstrates efficacy and safety advantages.

FAQs

1. What are the primary applications of perfluorohexyloctane?
It is used mainly as an ocular lubricant for dry eye disease and potentially other surface diseases.

2. How does PFHO differ from traditional artificial tears?
PFHO’s fluorinated structure provides longer-lasting lubrication and better retention on the ocular surface.

3. What are the main regulatory hurdles for PFHO?
Obtaining approvals in different regions, ensuring long-term safety data, and navigating fluorinated compound regulations.

4. How has the COVID-19 pandemic affected market dynamics?
Disrupted healthcare services and delayed clinical trials have caused slow adoption but increased awareness of ocular surface issues.

5. Are there commercial partnerships influencing PFHO’s market?
Yes, collaborations with ophthalmic device firms and pharma companies are underway to accelerate commercialization.

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References

[1] Craig, J. P., et al. (2017). The epidemiology of dry eye disease: report of the Joint EULAR/ACTA Task Force. Ocular Surface.