FLUOROMETHOLONE ACETATE - Generic Drug Details

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

Fluorometholone acetate is the generic ingredient in two branded drugs marketed by Harrow Eye and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FLUOROMETHOLONE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	3,174
What excipients (inactive ingredients) are in FLUOROMETHOLONE ACETATE?	FLUOROMETHOLONE ACETATE excipients list
DailyMed Link:	FLUOROMETHOLONE ACETATE at DailyMed

Recent Clinical Trials for FLUOROMETHOLONE ACETATE

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

Sponsor	Phase
Price Vision Group	Phase 4
Kala Pharmaceuticals, Inc.	Phase 4
University of Utah	Phase 4

See all FLUOROMETHOLONE ACETATE clinical trials

Pharmacology for FLUOROMETHOLONE ACETATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FLUOROMETHOLONE ACETATE

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for FLUOROMETHOLONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	TOBRASONE	fluorometholone acetate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050628-001	Jul 21, 1989		DISCN	No	No
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079-001	Feb 11, 1986		RX	Yes	Yes

FLUOROMETHOLONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorometholone Acetate

Introduction to Fluorometholone Acetate

Fluorometholone acetate, known by brand names such as Flarex, Florate, and Omnitrol, is a synthetic glucocorticoid corticosteroid and a progestogen. It is widely used in the treatment of various ocular disorders, including inflammation and allergies, as well as in some cases of breast cancer[2].

Market Size and Forecast

The global Fluorometholone Acetate market is anticipated to experience significant growth over the coming years. As of 2023, the market was valued at several million USD, and it is projected to reach a higher value by 2030, with a notable Compound Annual Growth Rate (CAGR)[1][4].

Key Players

The market is dominated by several major players, including:

• Eyevance Pharmaceuticals (Santen)
• Alcon
• Sentiss Pharma
• Cipla for the general Fluorometholone Acetate market[1].
• For the Fluorometholone Eye Drops segment, key players include Senju Pharmaceutical Co., Ltd., Alcon Inc., Bausch Health Companies Inc., and **Santen Pharmaceutical Co., Ltd.[3].

Market Drivers

Several factors are driving the growth of the Fluorometholone Acetate market:

Growing Prevalence of Eye Disorders

The increasing incidence of ocular disorders, allergies, and inflammation is a significant driver. As the global population ages, age-related eye conditions become more common, leading to higher demand for corticosteroid eye drops like Fluorometholone Acetate[3].

Formulation Advancements

New drug delivery methods and formulations that enhance the effectiveness and reduce the adverse effects of Fluorometholone Acetate are attracting more patients and healthcare professionals[3].

Growing Awareness of Eye Health

Increased awareness about the importance of eye health and the availability of treatment options is driving more people to seek medical care for ocular issues[3].

Growing Healthcare Spending

Rising healthcare and pharmaceutical spending in emerging economies is making eye care products more accessible[3].

Regulatory Approvals and New Product Launches

New product approvals and the introduction of generic versions are providing consumers with more options, thereby boosting market growth[3].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Regulatory Obstacles

Stringent regulations 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 and the risk of cataracts associated with corticosteroid treatment can limit patient acceptance and usage[3].

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 Acetate[3].

Market Saturation

The presence of numerous well-established brands makes it challenging for new entrants to gain market share[3].

Pricing Demand

Cost constraints and pressure from healthcare providers to reduce spending can lead to price wars, affecting corporate margins[3].

Market Segmentation

The Fluorometholone Acetate market is segmented based on several criteria:

By Type

The market is segmented into patented drugs and generic drugs[1].

By Application

Key applications include hospitals, drug stores, and online platforms[1].

By Geography

The market is segmented into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Each region has its unique demographic, regulatory, and healthcare dynamics[3].

Geographical Analysis

• North America: Characterized by a high demand for ophthalmic medications due to a high prevalence of eye disorders and a well-established healthcare infrastructure.
• Europe: Strong emphasis on healthcare accessibility and the presence of numerous pharmaceutical companies contribute to a robust market.
• Asia-Pacific: Poised for substantial growth driven by rising awareness of eye health, increasing disposable incomes, and a growing aging population.
• Latin America: Experiencing gradual growth supported by enhancing healthcare facilities and rising dermatological needs.
• Middle East and Africa: Witnessing improvement in healthcare access and eye care awareness initiatives, albeit at varying paces[3].

Financial Trajectory

The financial trajectory of the Fluorometholone Acetate market is promising, with significant growth projected over the next few years.

Revenue Forecast

The Fluorometholone Eye Drops market, for instance, 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].

Market Share and Ranking

Key players are expected to maintain their market share through innovative product offerings, strategic partnerships, and strong distribution networks[1][3].

Key Takeaways

• The Fluorometholone Acetate market is driven by the growing prevalence of eye disorders and advancements in drug formulations.
• Regulatory approvals and new product launches are crucial for market growth.
• The market faces restraints such as regulatory obstacles, side effects, and competition from alternative therapies.
• Geographical segmentation highlights varying market dynamics across different regions.
• The financial trajectory indicates significant growth, with the Fluorometholone Eye Drops market expected to reach USD 70.07 billion by 2031.

FAQs

Q: What are the primary applications of Fluorometholone Acetate? A: Fluorometholone Acetate is primarily used in the treatment of ocular disorders, including inflammation and allergies, as well as in some cases of breast cancer[2].

Q: Who are the major players in the Fluorometholone Acetate market? A: Key players include Eyevance Pharmaceuticals (Santen), Alcon, Sentiss Pharma, and Cipla for the general market, and Senju Pharmaceutical Co., Ltd., Alcon Inc., Bausch Health Companies Inc., and Santen Pharmaceutical Co., Ltd. for the eye drops segment[1][3].

Q: What are the main drivers of the Fluorometholone Acetate market? A: The market is driven by the growing prevalence of eye disorders, formulation advancements, growing awareness of eye health, and increasing healthcare spending[3].

Q: What are the potential restraints on the Fluorometholone Acetate market? A: Restraints include regulatory obstacles, side effects, competition from alternative therapies, market saturation, pricing demand, and patient adherence issues[3].

Q: How is the Fluorometholone Acetate market segmented geographically? A: The market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa, each with unique market dynamics[3].

Cited Sources

1. Valuates Reports: Fluorometholone Acetate Market Report.
2. Wikipedia: Fluorometholone acetate.
3. Verified Market Research: Fluorometholone Eye Drops Market Size, Trends & Forecast.
4. Market Research Reports: Fluorometholone Acetate - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
5. Patsnap: Fluorometholone Acetate - Drug Targets, Indications, Patents.