Fluorometholone - Generic Drug Details

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

Fluorometholone is the generic ingredient in eight branded drugs marketed by Pharmacia And Upjohn, Allergan, Novartis, Amneal, Difgen Pharms, Abbvie, and Harrow Eye, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for fluorometholone. Three suppliers are listed for this compound.

Summary for fluorometholone

US Patents:	0
Tradenames:	8
Applicants:	7
NDAs:	10
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	25
Patent Applications:	7,133
Drug Prices:	Drug price trends for fluorometholone
What excipients (inactive ingredients) are in fluorometholone?	fluorometholone excipients list
DailyMed Link:	fluorometholone at DailyMed

See drug prices for fluorometholone

Recent Clinical Trials for fluorometholone

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

Sponsor	Phase
Vishal Jhanji	PHASE2
University of Pittsburgh Medical Center	PHASE2
St. Joseph's Healthcare Hamilton	PHASE4

See all fluorometholone clinical trials

Pharmacology for fluorometholone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluorometholone

Anti-Allergic Agents

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for fluorometholone

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	FLAREX	fluorometholone acetate	SUSPENSION/DROPS;OPHTHALMIC	019079-001	Feb 11, 1986		RX	Yes	Yes
Pharmacia And Upjohn	OXYLONE	fluorometholone	CREAM;TOPICAL	011748-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Harrow Eye	TOBRASONE	fluorometholone acetate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050628-001	Jul 21, 1989		DISCN	No	No
Allergan	FML-S	fluorometholone; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	019525-001	Sep 29, 1989		DISCN	No	No

Market Dynamics and Financial Trajectory for Fluorometholone

Last updated: February 13, 2026

Overview

Fluorometholone is a synthetic corticosteroid used primarily in ophthalmology to treat allergic conjunctivitis, postoperative inflammation, and other ocular inflammatory conditions. Its market relies on therapeutic efficacy, competition, regulatory approvals, and manufacturing capacity. The global ophthalmic corticosteroids market is expanding owing to rising prevalence of eye diseases and increasing awareness.

Market Size and Growth Trends

The pharmaceutical market for ophthalmic corticosteroids, including fluorometholone, was valued around $500 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2028. Key drivers include:

• Increased cases of allergic and inflammatory eye conditions.
• Aging populations, particularly in North America and Europe.
• Advances in drug delivery systems.

Therapeutic Application and Market Segmentation

Fluorometholone's market is segmented by usage:

• Prescribed in postoperative inflammation (approximately 45% of sales).
• Used for allergic conjunctivitis (around 35%).
• Other inflammatory ocular conditions (remaining 20%).

Geographical distribution shows North America holds roughly 40% of the market, followed by Europe (30%), with Asia-Pacific rapidly expanding due to rising healthcare access and prevalence of eye disorders.

Regulatory & Competing Products

Several corticosteroids compete with fluorometholone, including prednisolone acetate and dexamethasone. Unlike potent corticosteroids, fluorometholone has a lower risk of intraocular pressure elevation, favoring its safety profile.

Regulatory pathways for approval vary, but fluorometholone generics are broadly accessible, affecting pricing pressure and profit margins. Innovations such as sustained-release formulations have potential to modify sales dynamics.

Manufacturing & Supply Chain

Most manufacturers source active pharmaceutical ingredients (APIs) from Asia-Pacific, primarily China and India. Manufacturing capacity constraints or regulatory issues can impact supply stability, influencing market prices.

Financial Forecast

Major pharmaceutical companies with fluorometholone portfolios report consistent sales. For example, if a company records annual sales of $50 million worldwide, a 5% CAGR suggests growth to approximately $63 million in five years.

Margins are influenced by:

• Patent expiration, leading to price erosion.
• Market penetration in emerging markets.
• Development of new formulations with improved delivery or safety profiles.

Key Companies and Market Shares

Leading firms include:

Company	Market Share	Notes
Alcon	30%	Robust ophthalmic portfolio, including fluorometholone
Santen Pharmaceutical	20%	Focus on eye health, strong regional presence
Novartis	15%	Portfolio diversification, generic production
Other players	35%	Generics and regional manufacturers

Pricing & Reimbursement Landscape

Pricing varies by region:

• North America: Generally higher, with reimbursement favoring prescribers.
• Europe: Reimbursement is regulated, influencing profit margins.
• Asia-Pacific: Lower prices, but rising sales volumes.

Government policies and insurance coverage significantly influence sales and profitability.

Risks & Opportunities

Risks include regulatory changes, patent expiries, and competition from more potent or reformulated corticosteroids. Opportunities lie in developing controlled-release formulations and expanding into emerging markets with growing healthcare infrastructure.

Conclusion

The fluorometholone market exhibits stable growth driven by rising ocular inflammatory conditions and expanding global ophthalmic care. Brand competition and regulatory factors will continue to influence revenue trajectories.

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Key Takeaways

• The global ophthalmic corticosteroid market, including fluorometholone, is projected to grow at 4-6% CAGR through 2028.
• North America and Europe account for the majority market share, but Asia-Pacific is expanding rapidly.
• Patent expirations and generics exert downward pressure on prices and margins.
• Supply chain dynamics, especially API sourcing, influence cost and availability.
• Innovation in drug delivery and formulations presents growth opportunities.

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FAQs

1. What is the primary indication for fluorometholone?
It treats ocular inflammatory conditions such as allergic conjunctivitis and postoperative inflammation.

2. How does fluorometholone compare to other corticosteroids?
It has a lower risk of intraocular pressure elevation, making it safer for long-term use compared to potent corticosteroids like prednisolone acetate.

3. What factors influence the pricing of fluorometholone?
Market competition, patent status, regulatory environment, and regional reimbursement policies.

4. Which regions are most important for fluorometholone sales?
North America and Europe currently hold the largest shares, but Asia-Pacific shows rapid growth potential.

5. What are the main risks facing fluorometholone market stakeholders?
Patent expiries, regulatory restrictions, competition from generics and reformulated drugs, supply chain disruptions.

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Citations

1. MarketsandMarkets. Ophthalmic corticosteroids market report, 2022.
2. GlobalData. Pharma industry analysis, 2022.
3. IQVIA. Pharmaceutical sales data, 2022.
4. Company annual reports and disclosures, 2022.
5. World Health Organization. Eye health statistics, 2022.