Perfluorohexyloctane - Generic Drug Details

What are the generic drug sources for perfluorohexyloctane and what is the scope of patent protection?

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 seven patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for perfluorohexyloctane

International Patents:	107
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
Bausch And Lomb Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes			Y

International Patents for perfluorohexyloctane

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1210041
Spain	2770398
Canada	3142049	COMPOSITIONS D'ALCANES SEMIFLUORES (SEMIFLUORINATED ALKANE COMPOSITIONS)
European Patent Office	3618782
Canada	2883002	COMPOSITIONS COMPRENANT DES MELANGES D'ALCANES SEMI-FLUORES (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)

Market Dynamics and Financial Trajectory for Perfluorohexyloctane

Last updated: July 30, 2025

Introduction

Perfluorohexyloctane (F6H8), a perfluorocarbon-based drug, has garnered interest within ophthalmology and medical device industries primarily for its potential in treating dry eye disease and related ocular conditions. Its unique properties, including high oxygen solubility and inertness, position it as a promising candidate amid evolving therapeutic and delivery systems. This report delineates the current market dynamics and forecasts the financial trajectory of perfluorohexyloctane, considering scientific, regulatory, and competitive factors shaping its adoption.

Pharmacological Profile and Clinical Development

Perfluorohexyloctane belongs to the perfluorocarbon (PFC) family, known for their high gas solubility and biocompatibility. Originally developed as an artificial oxygen carrier, its off-label and investigational uses have expanded into ocular therapies, particularly as an eye drop or filling agent to stabilize the tear film and enhance oxygenation in the cornea. Clinical trials, notably in Europe and North America, have demonstrated its safety profile and efficacy in reducing corneal damage in dry eye and persistent epithelial defects. Yet, widespread adoption remains contingent upon regulatory approvals and further validation studies.

Market Landscape and Drivers

1. Growing Prevalence of Dry Eye Disease
   The dry eye market has expanded dramatically, driven by increased screen time, environmental factors, and aging populations. According to the Tear Film & Ocular Surface Society (TFOS), dry eye affects approximately 5-50% of individuals over 50 globally, presenting a substantial therapeutic market [1]. Existing treatments like lubricating drops and anti-inflammatory agents offer symptomatic relief but often lack long-term efficacy, creating an unmet need that perfluorohexyloctane could address.

2. Innovative Therapeutic Approaches
   Advances in biomaterials and sustained-release formulations are fueling interest in PFC-based ocular therapies. Perfluorohexyloctane's inertness and ability to form an oxygen-permeable layer foster its potential as a next-generation treatment. Physicians and patients may prefer these novel options if proven safe and cost-effective.

3. Regulatory and Reimbursement Environment
   Regulatory pathways have been somewhat streamlined within the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), especially when existing PFC technology demonstrates safety. However, approval hinges on comprehensive clinical data demonstrating superiority or added benefit over existing therapies. Payers' willingness to reimburse novel treatments will influence market penetration.

4. Manufacturing and Supply Chain Considerations
   Manufacturing PFCs like perfluorohexyloctane involves high-purity chemical processes, stringent quality controls, and specialized facilities. Scaling production sustainably is vital for meeting demand, especially if regulatory approval broadens its use.

Market Challenges and Risks

• Safety and Tolerability Concerns
  Despite favorable clinical data, long-term safety remains under evaluation. Potential issues such as accumulation, alteration of the ocular surface, or immune responses could hinder commercialization.

• Competition from Established and Emerging Therapies
  Existing treatments, including artificial tears, cyclosporine drops, and biological agents, already serve the dry eye market. The entry of PFC-based products must demonstrate clear clinical and economic advantages.

• Regulatory Hurdles
  Regulatory approval delays or rejections will impede market entry and financial realization. Clear demonstration of safety, efficacy, and manufacturing excellence is mandatory.

Financial Trajectory and Market Potential

The global ophthalmic drug market is expected to reach USD 18 billion by 2025, with dry eye therapies accounting for a growing segment [2]. As a novel agent, perfluorohexyloctane's commercial success will depend on various factors:

• Regulatory Approval Milestones:
  Securing regulatory acceptance in major markets (USA, EU, Asia) would unlock significant revenue streams. Given current clinical data, regulators may require additional pivotal trials, potentially extending the timeline and increasing R&D investments.

• Market Penetration Strategies:
  Early adoption in specialized ophthalmology centers, supported by real-world evidence, can facilitate wider acceptance. Strategic collaborations with key opinion leaders and payers will be essential.

• Pricing and Reimbursement:
  Pricing strategies must balance recouping R&D costs and ensuring affordability. Value-based pricing aligned with demonstrated clinical benefits could enhance reimbursement prospects.

• Forecasted Revenue Streams:
  Initially, revenue generation may be modest during the regulatory process (USD 10-50 million annually). Post-approval, with market penetration estimates of 5-10%, revenues could soar to USD 200-300 million within five years, contingent on approval breadth and uptake.

Investment and Commercial Outlook

Private and public investors' interest hinges on clinical data strength, regulatory signals, and competitive positioning. Companies like Novaliq and other innovative ophthalmic biotech firms have demonstrated the capacity for mid-term valuation increases through successful drug development.

The future financial trajectory of perfluorohexyloctane hinges on its capacity to demonstrate superior clinical efficacy and safety, navigate regulatory landscapes efficiently, and establish robust manufacturing and distribution channels. As such, the drug is positioned for significant growth but remains sensitive to scientific, regulatory, and market uncertainties.

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Key Takeaways

• The expanding dry eye market and unmet medical needs position perfluorohexyloctane as a promising therapeutic candidate.
• Its unique properties may provide advantages over traditional treatments, contingent on positive clinical and safety data.
• Regulatory approvals and payer acceptance are critical to unlocking the product's commercial potential.
• Commercial success depends on scaled manufacturing, competitive pricing, and demonstrated clinical benefits.
• Strategic collaboration, thorough safety assessments, and targeted marketing will influence long-term financial outcomes.

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FAQs

1. What advantages does perfluorohexyloctane offer over existing dry eye treatments?
Perfluorohexyloctane’s inertness and high oxygen solubility may enhance tear film stability and corneal oxygenation, potentially providing longer-lasting relief and promoting tissue healing beyond symptomatic lubrication.

2. What are the main regulatory challenges for bringing perfluorohexyloctane to market?
Regulators require comprehensive safety and efficacy data, particularly for long-term use. Given its novel PFC chemistry, detailed toxicology, bio-persistence, and manufacturing process validation are critical hurdles.

3. How does the manufacturing complexity of perfluorohexyloctane impact its market potential?
High-purity production and specialized facilities increase costs but are necessary to meet regulatory standards. Efficient supply chain management is essential to meet anticipated demand without excessive pricing.

4. What is the projected timeline for commercial availability of perfluorohexyloctane?
Pending completion of pivotal clinical trials and regulatory review, commercialization might occur within 3-5 years, assuming no significant hurdles.

5. How does market competition influence the adoption of perfluorohexyloctane?
Existing therapies with established safety and reimbursement frameworks pose barriers. Differentiation through superior efficacy, safety, or convenience will be crucial for market penetration.

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Sources

[1] TFOS DEWS II Epidemiology Report, 2017.
[2] Market Research Future, "Ophthalmic drugs Market Analysis," 2022.