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Last Updated: December 27, 2024

PERFLUOROHEXYLOCTANE - Generic Drug Details


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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 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: 5
Patent Applications: 157
What excipients (inactive ingredients) are in PERFLUOROHEXYLOCTANE?PERFLUOROHEXYLOCTANE excipients list
DailyMed Link:PERFLUOROHEXYLOCTANE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PERFLUOROHEXYLOCTANE
Generic Entry 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

SponsorPhase
Gordon Schanzlin New VisionPhase 4
Novaliq GmbHPhase 3
Bausch & Lomb IncorporatedPhase 3

See all PERFLUOROHEXYLOCTANE clinical trials

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 11,357,738 ⤷  Subscribe Y ⤷  Subscribe
Bausch And Lomb Inc MIEBO perfluorohexyloctane SOLUTION/DROPS;OPHTHALMIC 216675-001 May 18, 2023 RX Yes Yes 10,507,132 ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb Inc MIEBO perfluorohexyloctane SOLUTION/DROPS;OPHTHALMIC 216675-001 May 18, 2023 RX Yes Yes 10,449,164 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PERFLUOROHEXYLOCTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Perfluorohexyloctane

Introduction

Perfluorohexyloctane (PFHO) has emerged as a significant player in the specialty chemicals and pharmaceutical markets, particularly in the treatment of dry eye disease (DED). Here, we delve into the market dynamics, financial trajectory, and key factors influencing the growth of PFHO.

Market Growth and Projections

The perfluorohexyloctane market is anticipated to experience robust growth over the forecast period from 2023 to 2031. This growth is driven by the compound's unique properties, such as high stability, chemical inertness, and resistance to heat and environmental degradation[1][4].

  • Market Size and Forecast: The market is expected to see significant expansion, with projections indicating continued growth. The global perfluorohexyloctane market is segmented by type (98% purity, 99% purity) and application (eye drops, pharmaceutical intermediates, other), with geographical regions also playing a crucial role[1].

Key Drivers

Several factors are driving the growth of the perfluorohexyloctane market:

Increasing Demand in Ophthalmology

  • The rising incidence of age-related eye diseases and the growing demand for effective treatments for dry eye disease are major drivers. PFHO, marketed as Miebo by Bausch + Lomb, is the first and only water-free drop to target tear evaporation, relieving signs and symptoms of DED[2][5].

Technological Advancements

  • Improvements in synthesis techniques and advanced formulations have enhanced the purity and yield of PFHO, making it more accessible and cost-effective. These technological advancements are crucial for expanding its range of applications[4].

Strategic Partnerships and Mergers

  • Collaborations between chemical manufacturers and technology firms are leading to the development of new applications and enhanced production techniques. For example, Bausch + Lomb's acquisition of Xiidra from Novartis strengthens its position in the DED market and expands its portfolio[2][4].

Financial Trajectory

The financial outlook for PFHO is promising, driven by several key financial indicators:

Acquisition and Investment

  • Bausch + Lomb's acquisition of Xiidra and other related assets from Novartis for up to $2.5 billion highlights the significant financial investment in the DED market. This acquisition is expected to accelerate margin expansion and provide strong earnings accretion[2].

Revenue Projections

  • The ocular drug delivery market, which includes PFHO, is expected to grow from $17.39 billion in 2023 to $24.98 billion by 2028, at a CAGR of 7.6%. This growth is indicative of the increasing revenue potential for PFHO and related products[3].

Sales Performance

  • Xiidra, another product in Bausch + Lomb's dry eye portfolio, generated approximately $487 million in sales in 2022. The addition of Miebo (PFHO) to this portfolio is expected to further boost sales and revenue[2].

Market Segmentation

The perfluorohexyloctane market is segmented into several key categories:

By Type

  • The market is categorized into 98% purity and 99% purity segments, each with its own set of applications and market dynamics[1].

By Application

  • The primary applications include eye drops, pharmaceutical intermediates, and other industrial uses. The eye drops segment, particularly for DED treatment, is a significant growth area[1].

By Geography

  • The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth prospects and market dynamics[1].

Safety and Efficacy

Recent studies have reinforced the safety and efficacy of PFHO in treating DED:

  • Long-Term Safety and Efficacy: A phase 3 study (KALAHARI) demonstrated that PFHO ophthalmic drops were safe and well-tolerated, maintaining efficacy for improving signs and symptoms of DED over a year-long period[5].

Sustainability Efforts

There is a growing focus on sustainability within the perfluorohexyloctane market:

  • Eco-Friendly Production: Manufacturers are exploring eco-friendly production methods and alternative formulations that reduce environmental impact while maintaining performance characteristics[4].

Challenges and Opportunities

While the market for PFHO is promising, there are challenges and opportunities to consider:

  • Regulatory Environment: Compliance with regulatory standards and ensuring the safety and efficacy of the product are crucial for market success.
  • Competitive Landscape: The market is competitive, with several players vying for market share. Strategic partnerships and innovative product launches can help companies stay ahead.
  • New Applications: Developing new applications and improving manufacturing processes offer significant opportunities for growth and expansion[1][4].

Key Players

Several key players are driving the growth of the perfluorohexyloctane market:

  • Bausch + Lomb: With the acquisition of Xiidra and the launch of Miebo, Bausch + Lomb is a major player in the DED market.
  • Shandong Zhongshan Photoelectric Materials: This company, along with others like Zhejiang NHU Company and Shanghai Jinghui Industrial, is profiled in market reports for their significant contributions to the perfluorohexyloctane market[1].

Conclusion

The perfluorohexyloctane market is poised for significant growth, driven by its unique properties, technological advancements, and strategic partnerships. As the demand for effective treatments for dry eye disease continues to rise, PFHO is set to play a crucial role in the ophthalmology and specialty chemicals markets.

Key Takeaways

  • Robust Market Growth: The perfluorohexyloctane market is expected to see robust growth from 2023 to 2031.
  • Technological Advancements: Improvements in synthesis techniques and formulations are enhancing the market.
  • Strategic Partnerships: Collaborations between manufacturers and technology firms are driving innovation.
  • Financial Trajectory: Significant financial investments and revenue projections indicate a promising financial outlook.
  • Safety and Efficacy: Recent studies have confirmed the long-term safety and efficacy of PFHO in treating DED.

FAQs

What are the primary applications of perfluorohexyloctane?

The primary applications include eye drops for treating dry eye disease, pharmaceutical intermediates, and other industrial uses such as high-performance lubricants and coatings.

Which company recently acquired Xiidra to bolster its dry eye portfolio?

Bausch + Lomb acquired Xiidra from Novartis to strengthen its position in the dry eye disease market.

What are the key drivers of the perfluorohexyloctane market growth?

Key drivers include increasing demand in ophthalmology, technological advancements, and strategic partnerships.

Is perfluorohexyloctane safe and effective for treating dry eye disease?

Yes, recent studies have demonstrated that perfluorohexyloctane ophthalmic drops are safe and well-tolerated, maintaining efficacy for improving signs and symptoms of DED over a year-long period.

What is the projected market size for the ocular drug delivery market by 2028?

The ocular drug delivery market is expected to grow to $24.98 billion by 2028 at a CAGR of 7.6%.

Sources

  1. Market Research Intellect: Global Perfluorohexyloctane Market Size, Scope And Forecast Report.
  2. Optometry Times: Bausch + Lomb announces acquisition of Xiidra from Novartis.
  3. Research and Markets: Ocular Drug Delivery Global Market Size & Forecast to 2028.
  4. Market Research Intellect: Perfluorohexyloctane Market Size And Projection.
  5. PubMed: Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Drop for Treatment of Dry Eye Disease.

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