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Last Updated: December 22, 2024

FLUOROMETHOLONE Drug Patent Profile


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Which patents cover Fluorometholone, and when can generic versions of Fluorometholone launch?

Fluorometholone is a drug marketed by Amneal and is included in one NDA.

The generic ingredient in FLUOROMETHOLONE is fluorometholone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluorometholone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluorometholone

A generic version of FLUOROMETHOLONE was approved as fluorometholone by AMNEAL on January 9th, 2024.

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Drug patent expirations by year for FLUOROMETHOLONE
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US Patents and Regulatory Information for FLUOROMETHOLONE

FLUOROMETHOLONE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal FLUOROMETHOLONE fluorometholone SUSPENSION/DROPS;OPHTHALMIC 216348-001 Jan 9, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FLUOROMETHOLONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorometholone

Introduction to Fluorometholone

Fluorometholone is a corticosteroid eye drop used to treat various eye conditions caused by inflammation, such as swelling of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth Projections

The fluorometholone market has been experiencing significant growth and is expected to continue this trend. As of 2023, the fluorometholone eye drops market was valued at approximately USD 41.65 billion and is projected to reach USD 70.07 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.34% during the forecast period from 2024 to 2031[3].

Market Drivers

Several factors are driving the growth of the fluorometholone market:

  • Growing Prevalence of Eye Disorders: The increasing incidence of ocular disorders, allergies, and inflammation is driving the demand for efficient treatment options like fluorometholone eye drops[3].
  • Aging Population: As the global population ages, age-related eye disorders become more common, increasing the demand for corticosteroid eye drops[3].
  • Formulation Advancements: New drug delivery methods and formulations that enhance the effectiveness and reduce the adverse effects of fluorometholone are attracting more patients and medical professionals[3].
  • Growing Awareness of Eye Health: Increased awareness of the importance of eye health and the availability of treatment options is leading to higher usage of eye drugs, including fluorometholone[3].
  • Regulatory Approvals and New Product Launches: The approval and launch of new products, including generic versions, provide additional options for customers and boost market growth[2][3].

Market Restraints and Challenges

Despite the positive growth drivers, the market faces several challenges:

  • Regulatory Obstacles: Stringent laws and lengthy approval processes for ophthalmic drugs can hinder the entry of new products into the market[3].
  • Limitations and Side Effects: Adverse effects such as increased intraocular pressure, risk of cataracts, and delayed eye wound healing can limit patient acceptance and usage[2][4].
  • Competition from Alternatives: The availability of alternative therapies, such as non-steroidal anti-inflammatory drugs (NSAIDs) and newer anti-inflammatory medications, can reduce demand for fluorometholone[3].
  • Market Saturation: The presence of numerous well-established brands makes it challenging for new entrants to gain market share[3].
  • Pricing and Economic Factors: Cost constraints and demand from healthcare providers to reduce spending can lead to price wars, impacting corporate margins. Economic downturns may also result in lower healthcare expenditures, affecting the market[3].

Segmentation Analysis

The fluorometholone market is segmented based on several criteria:

  • Type: The market is categorized into patented and generic drugs. The launch of complex generic versions, such as Amneal's fluorometholone ophthalmic suspension, is a significant development in this segment[1][2].
  • Application: The market is segmented by application into hospitals, drug stores, and online channels. The online segment is growing due to increased convenience and accessibility[1].
  • Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region has unique demographic, regulatory, and healthcare dynamics that influence market growth[1][3].

Key Players

The fluorometholone market is dominated by several key players:

  • Senju Pharmaceutical Co., Ltd.
  • Alcon Inc.
  • Bausch Health Companies Inc.
  • Santen Pharmaceutical Co., Ltd.
  • Allergan
  • Sam Chun Dang Pharm.Co., Ltd.
  • Tianjin Kingyork Group Hebei Univision Pharmaceutical Co., Ltd.[3][5]

These companies are involved in various market-related activities, including new product launches, collaborations, mergers and acquisitions, and expanding their regional and industry footprint.

Financial Performance and Projections

The financial performance of the fluorometholone market is robust, with significant revenue growth expected. For instance, U.S. annual sales for fluorometholone ophthalmic suspension were approximately $62 million for the 12 months ended November 2023[2].

The market's financial trajectory is influenced by factors such as product pricing, market penetration, and the dynamics of parent markets and their submarkets. The growing demand for ophthalmic medications, particularly in regions like North America and Europe, contributes to the market's financial health[1][3].

Regional Market Dynamics

North America

This region is characterized by a high prevalence of eye disorders and a well-established healthcare infrastructure. Advanced research and development capabilities, along with stringent regulatory frameworks, ensure quality and efficacy of ophthalmic medications[3].

Europe

Europe has a strong emphasis on healthcare accessibility, and the presence of numerous pharmaceutical companies contributes to a robust market for fluorometholone eye drops[3].

Asia-Pacific

This region is poised for substantial growth driven by rising awareness of eye health, increasing disposable incomes, and a growing aging population. Countries in this region are witnessing improvements in healthcare access and eye care awareness initiatives[3].

Latin America and Middle East & Africa

These regions are experiencing gradual growth, supported by enhancing healthcare facilities and rising dermatological needs among the population. However, the pace of growth varies due to diverse economic conditions and healthcare policies[3].

Regulatory Environment

The regulatory environment plays a crucial role in the fluorometholone market. For example, Amneal's fluorometholone ophthalmic suspension received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, which is a significant regulatory approval[2].

Side Effects and Precautions

While fluorometholone is effective in treating eye inflammation, it comes with potential side effects such as increased intraocular pressure, risk of cataracts, and delayed eye wound healing. Regular eye exams are necessary to monitor these effects and ensure the medicine is working properly[4].

Key Takeaways

  • The fluorometholone market is expected to grow significantly, driven by increasing prevalence of eye disorders and advancements in drug formulations.
  • Key players are expanding their product portfolios and geographical presence.
  • Regulatory approvals and new product launches are crucial for market growth.
  • The market faces challenges such as regulatory obstacles, side effects, and competition from alternative therapies.
  • Regional dynamics vary, with North America and Europe being key markets due to their well-established healthcare infrastructures.

Frequently Asked Questions (FAQs)

1. What is fluorometholone used for?

Fluorometholone is a corticosteroid used to treat eye conditions caused by inflammation, such as swelling of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe[4].

2. What are the potential side effects of fluorometholone?

Potential side effects include increased intraocular pressure, risk of cataracts, delayed eye wound healing, and other eye problems such as glaucoma. Common side effects also include burning, dry, or itching eyes, and redness or swelling of the eye or eyelid[4].

3. Who are the key players in the fluorometholone market?

Key players include Senju Pharmaceutical Co., Ltd., Alcon Inc., Bausch Health Companies Inc., Santen Pharmaceutical Co., Ltd., Allergan, Sam Chun Dang Pharm.Co., Ltd., and Tianjin Kingyork Group Hebei Univision Pharmaceutical Co., Ltd.[3][5].

4. What is the market size and growth projection for fluorometholone eye drops?

The fluorometholone eye drops market was valued at USD 41.65 billion in 2023 and is projected to reach USD 70.07 billion by 2031, growing at a CAGR of 5.34% during the forecast period[3].

5. What are the main drivers of the fluorometholone market?

The main drivers include the growing prevalence of eye disorders, an aging population, formulation advancements, growing awareness of eye health, and increasing healthcare spending in emerging economies[3].

Cited Sources:

  1. Market Research Intellect: Fluorometholone Market Size, Scope And Forecast Report[1]
  2. Amneal Pharmaceuticals: Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension[2]
  3. Verified Market Research: Fluorometholone Eye Drops Market Size, Trends & Forecast[3]
  4. Mayo Clinic: Fluorometholone (ophthalmic route)[4]
  5. Valuates Reports: Global Fluorometholone Eye Drops Market Research Report 2024[5]

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