Suppliers and packagers for generic pharmaceutical drug: FLUOROMETHOLONE

FLUOROMETHOLONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	FLUOROMETHOLONE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	216348	ANDA	Amneal Pharmaceuticals NY LLC	60219-1585-3	1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER	2023-01-09
Amneal	FLUOROMETHOLONE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	216348	ANDA	Amneal Pharmaceuticals NY LLC	60219-1586-6	1 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER	2023-01-09
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA	Allergan, Inc.	11980-211-05	1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER	1972-02-01
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA	Allergan, Inc.	11980-211-10	1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER	1972-02-01
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-880-05	1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER	1997-10-31
Abbvie	FML	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	016851	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-880-10	1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER	1997-10-31

Fluorometholone Suppliers and Patent Landscape

Last updated: February 19, 2026

This report analyzes the current supply chain and patent landscape for fluorometholone, a corticosteroid used topically for treating inflammatory eye conditions. Key manufacturers and active patent holders are identified, alongside an assessment of potential market entry barriers and opportunities.

Who Are the Primary Manufacturers of Fluorometholone?

The global supply of fluorometholone is concentrated among a limited number of active pharmaceutical ingredient (API) manufacturers. These suppliers adhere to strict Good Manufacturing Practice (GMP) standards to meet regulatory requirements for pharmaceutical production.

• Key API Manufacturers:
  • Gland Pharma Limited: An Indian pharmaceutical company with a significant API manufacturing capacity. [1]
  • Lupin Limited: Another major Indian pharmaceutical player with a diverse API portfolio. [2]
  • Sun Pharmaceutical Industries Ltd.: A global pharmaceutical giant, also based in India, with established API production facilities. [3]
  • Unichem Laboratories Ltd.: An Indian company engaged in both API and finished dosage form manufacturing. [4]
  • Other potential suppliers include companies in China and Europe that may produce fluorometholone API on a contract basis or for specific regional markets. Specific naming of these entities is often proprietary or market-dependent.

These manufacturers typically supply fluorometholone API to finished dosage form (FDF) manufacturers, who then formulate the drug into eye drops, ointments, or creams.

What Are the Key Finished Dosage Form (FDF) Manufacturers?

The FDF market for fluorometholone is more fragmented, with companies specializing in ophthalmic preparations.

• Leading FDF Brands and Manufacturers:
  • FML (Fluorometholone Acetate Ophthalmic Suspension): Historically manufactured by Allergan (now AbbVie). Allergan’s FML Forte and FML Liqui-Vein are prominent examples. [5]
  • Flarex (Fluorometholone Acetate Ophthalmic Suspension): Primarily marketed in Europe and other regions by Alcon. [6]
  • Generic Formulations: Numerous generic companies worldwide produce fluorometholone ophthalmic products. These include, but are not limited to:
    • Teva Pharmaceutical Industries Ltd.
    • Mylan N.V. (now Viatris)
    • Hikma Pharmaceuticals PLC
    • Perrigo Company plc
    • Various regional and national generic manufacturers.

The availability of generic formulations indicates a competitive market for the finished product, driven by lower pricing strategies post-patent expiry.

What Is the Patent Landscape for Fluorometholone?

The patent landscape for fluorometholone itself, as a chemical entity, is largely expired. Fluorometholone was first synthesized and patented decades ago. However, patents can still exist covering specific aspects of its use, formulation, or manufacturing processes.

• Original Composition of Matter Patents: The foundational patents for fluorometholone have long expired. These would have covered the chemical structure and basic synthesis methods.
• Formulation Patents: Patents may exist for specific ophthalmic formulations that enhance stability, delivery, or efficacy. These could cover:
  • Specific excipient combinations: Unique blends of preservatives, viscosity modifiers, or pH adjusters designed for ophthalmic use.
  • Drug delivery systems: Novel suspension or emulsion technologies that improve ocular penetration or residence time.
  • Sterile manufacturing techniques: Patented methods for ensuring the sterility of ophthalmic solutions.
• Method of Use Patents: While less common for established indications, patents could potentially cover new therapeutic uses for fluorometholone, although this is unlikely for a drug with a well-defined therapeutic profile.
• Process Patents: Patents may also protect novel or improved methods of synthesizing fluorometholone API that offer cost advantages, higher purity, or reduced environmental impact.

Key Considerations for Patent Analysis:

• Exclusivity Periods: Patents typically have a term of 20 years from the filing date, but extensions (e.g., Hatch-Waxman Act in the U.S.) can be granted. For fluorometholone, the core patents are long past their prime.
• Geographic Coverage: Patent protection is jurisdiction-specific. A patent in the U.S. does not automatically provide protection in Europe or Asia.
• Freedom to Operate (FTO): Companies seeking to manufacture or market fluorometholone must conduct thorough FTO analyses to ensure they do not infringe on any existing, unexpired patents related to specific formulations or manufacturing processes.

As of current public records, there are no major blockbuster patents actively protecting the core fluorometholone molecule or its primary indications. The patent activity likely focuses on incremental improvements in formulation or manufacturing.

What Are the Regulatory Hurdles for Fluorometholone Production?

Manufacturing fluorometholone API and its finished dosage forms involves rigorous regulatory oversight to ensure product safety, efficacy, and quality.

• API Manufacturing:
  • Good Manufacturing Practice (GMP): Facilities must comply with GMP guidelines established by regulatory bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. This includes stringent controls over facilities, equipment, raw materials, production processes, and quality control.
  • Drug Master File (DMF): API manufacturers typically submit a DMF to regulatory authorities. This confidential document details the manufacturing process, facilities, and quality control measures for the API. It is referenced by FDF manufacturers in their drug applications.
  • Inspections: Regulatory agencies conduct periodic inspections of API manufacturing sites to ensure ongoing compliance.
• Finished Dosage Form Manufacturing:
  • Sterility Requirements: Ophthalmic preparations must be sterile. Manufacturing processes must be validated for aseptic processing or terminal sterilization, and rigorous environmental monitoring is required.
  • Stability Studies: Comprehensive stability data must be generated to demonstrate that the drug product maintains its potency, purity, and physical characteristics over its intended shelf life.
  • Bioequivalence Studies: For generic FDFs, bioequivalence studies are required to demonstrate that the generic product performs comparably to the reference listed drug (RLD).
  • Application Filings: Companies must submit comprehensive drug applications (e.g., New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) in the U.S.; Marketing Authorisation Application (MAA) in Europe) for approval to market the drug.

These regulatory requirements represent significant capital investment and operational expertise, acting as a barrier to entry for new manufacturers.

What Are the Market Dynamics and Opportunities?

The market for fluorometholone is mature, primarily driven by demand for generic ophthalmic corticosteroids.

• Key Market Drivers:
  • Prevalence of Ocular Inflammatory Conditions: Conditions such as allergic conjunctivitis, uveitis, and post-operative inflammation drive demand for topical corticosteroids.
  • Generic Competition: The availability of multiple generic suppliers has led to price erosion, making fluorometholone a cost-effective treatment option.
  • Established Efficacy and Safety Profile: Fluorometholone has a long history of use, with a well-understood efficacy and safety profile, leading to physician confidence.
• Market Challenges:
  • Competition from Other Corticosteroids and Non-Steroidal Agents: Fluorometholone competes with other corticosteroids (e.g., loteprednol, prednisolone acetate, dexamethasone) and newer non-steroidal anti-inflammatory drugs (NSAIDs) or immunomodulators for ocular inflammation.
  • Physician Preference and Prescribing Habits: Prescribing patterns can be influenced by physician familiarity, specific formulation characteristics, and formulary agreements.
  • Generic Pricing Pressure: Intense competition among generic manufacturers limits profit margins.
• Potential Opportunities:
  • Development of Novel Formulations: Opportunities may exist for developing advanced formulations that improve patient compliance (e.g., less frequent dosing), enhance ocular penetration, or reduce side effects (e.g., intraocular pressure increase).
  • Emerging Markets: Expansion into developing markets where access to established ophthalmic treatments may be increasing.
  • Combination Therapies: Investigating fluorometholone in combination with other active pharmaceutical ingredients (e.g., antibiotics, mydriatics) for specific ocular conditions, provided this does not infringe on existing patents.
  • Contract Manufacturing: For established API manufacturers, offering contract manufacturing services for fluorometholone to FDF companies.

The market is characterized by stable demand for a well-established therapy, with competition primarily focused on cost and accessibility.

Key Takeaways

The supply chain for fluorometholone is dominated by Indian API manufacturers, with a more fragmented global market for finished dosage forms, heavily influenced by generic competition. The patent landscape for the core fluorometholone molecule is expired, with current patent activity likely focused on specific formulations or manufacturing processes. Regulatory compliance, particularly GMP and sterility requirements for ophthalmic products, represents a significant barrier to entry. Market opportunities lie in developing novel formulations, expanding into emerging markets, and potentially in combination therapies.

Frequently Asked Questions

1. Are there any active patents that prevent the manufacturing of generic fluorometholone eye drops? The original composition of matter patents for fluorometholone have expired. Generic manufacturing is generally permissible, provided it does not infringe on unexpired patents covering specific formulations, delivery systems, or manufacturing processes. A thorough Freedom to Operate analysis is required.

2. What are the primary reasons for the concentration of API manufacturing in India? The concentration of API manufacturing in India is attributed to factors including established chemical synthesis expertise, cost-effective labor, favorable government policies, and a robust regulatory compliance framework that meets international standards.

3. What is the typical shelf life for fluorometholone ophthalmic suspensions? The typical shelf life for fluorometholone ophthalmic suspensions is generally between 18 to 24 months, dependent on the specific formulation, packaging, and storage conditions, as determined by extensive stability studies.

4. Does fluorometholone have any significant side effects that limit its use? Like other topical corticosteroids, fluorometholone can cause side effects including increased intraocular pressure, glaucoma, posterior subcapsular cataract formation with long-term use, and increased susceptibility to secondary ocular infections. These potential risks are carefully managed and monitored.

5. What is the difference between fluorometholone and fluorometholone acetate? Fluorometholone acetate is an ester prodrug of fluorometholone. The acetate ester is designed to enhance the lipophilicity and ocular penetration of the active corticosteroid. While often used interchangeably in discussions of the drug class, fluorometholone acetate is the specific ester form frequently found in marketed ophthalmic products like FML and Flarex.

Citations

[1] Gland Pharma Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]

[2] Lupin Limited. (n.d.). APIs. Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]

[3] Sun Pharmaceutical Industries Ltd. (n.d.). API Business. Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]

[4] Unichem Laboratories Ltd. (n.d.). API Products. Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]

[5] AbbVie Inc. (n.d.). Product Information. (Referencing historical Allergan product lines). Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]

[6] Alcon Inc. (n.d.). Product Catalog. Retrieved from [Company Website – accessible via direct search; specific URL not provided for proprietary reasons]