FLUOROMETHOLONE; SULFACETAMIDE SODIUM - Generic Drug Details

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

Fluorometholone; sulfacetamide sodium is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for FLUOROMETHOLONE; SULFACETAMIDE SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	FLUOROMETHOLONE; SULFACETAMIDE SODIUM at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for FLUOROMETHOLONE; SULFACETAMIDE SODIUM

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

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

S01AB	Sulfonamides
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

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; SULFACETAMIDE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	FML-S	fluorometholone; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	019525-001	Sep 29, 1989		DISCN	No	No

Fluorometholone and Sulfacetamide Sodium Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 6, 2026

Fluorometholone and sulfacetamide sodium are mature, low-cost prescription medicines with limited remaining intellectual-property protection. Fluorometholone is concentrated in ophthalmic corticosteroid products, while sulfacetamide sodium is sold across ophthalmic, dermatologic, and acne indications. Both markets are generic-driven, price sensitive, and fragmented. Public filings generally do not report product-level revenue, so financial analysis relies on market structure, prescription demand, product availability, manufacturer participation, and reimbursement dynamics.

What are the principal products and indications for fluorometholone and sulfacetamide sodium?

Fluorometholone is a topical ophthalmic corticosteroid used to treat steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. Products include ophthalmic suspension and ophthalmic ointment formulations.

Sulfacetamide sodium is a sulfonamide antibacterial. It is used in ophthalmic solutions and in topical dermatology products for acne vulgaris, seborrheic dermatitis, and related skin conditions.

Active ingredient	Main dosage forms	Principal indications	Commercial position
Fluorometholone	Ophthalmic suspension, ophthalmic ointment	Ocular inflammation and steroid-responsive disease	Mature ophthalmic generic
Sulfacetamide sodium	Ophthalmic solution, lotion, cleanser, cream, suspension	Eye infections, acne, seborrheic dermatitis	Mature ophthalmic and dermatology generic
Fluorometholone combinations	Ophthalmic suspension with anti-infective agents	Inflammation with suspected or confirmed bacterial infection	Smaller combination-product segment
Sulfacetamide sodium and sulfur	Lotion, cleanser, suspension	Acne and seborrheic dermatitis	Branded-generic dermatology segment

Historical branded products include FML and FML Forte for fluorometholone and Klaron, Ovace, Plexion, and related products for sulfacetamide sodium formulations. Brand ownership and commercialization have changed over time through acquisitions, divestitures, and licensing transactions.

What is the FDA regulatory status of fluorometholone and sulfacetamide sodium?

Both active ingredients are established prescription drugs with long FDA histories. Generic versions are generally approved through abbreviated new drug applications, or ANDAs, when the applicant demonstrates pharmaceutical equivalence and bioequivalence or meets the applicable product-specific requirements.

Fluorometholone FDA status

Fluorometholone ophthalmic products are prescription products regulated under the ophthalmic drug framework. Generic products include 0.1% ophthalmic suspension and, depending on market availability, other strengths and dosage forms.

The key regulatory issues are:

• Sterility and microbiological quality.
• Particle size and suspension uniformity.
• Dose delivery from the container.
• Preservative performance.
• In-use stability.
• Container-closure compatibility.
• Demonstration of equivalence to the reference product.

Ophthalmic suspensions can be more difficult to manufacture consistently than simple ophthalmic solutions. That creates a modest technical barrier, but it does not create durable exclusivity once multiple approved suppliers are available.

Sulfacetamide sodium FDA status

Sulfacetamide sodium ophthalmic solutions are typically approved as generic prescription products. Dermatology products may be approved under ANDAs or older new drug applications, depending on the product and regulatory history.

The market includes:

• Ophthalmic solution.
• Topical lotion.
• Facial cleanser.
• Cream.
• Gel or suspension.
• Combination products containing sulfur.

Topical dermatology products can face greater formulation complexity than ophthalmic solutions because vehicle composition, spreadability, residue, odor, pH, and skin tolerability affect substitution and prescribing behavior.

What patents protect fluorometholone products?

The principal patent protection for fluorometholone products has expired. Fluorometholone was commercialized decades ago, and the basic active-ingredient and original product protection is no longer an effective barrier to generic entry.

Patent category	Current commercial relevance
Fluorometholone compound patents	Expired
Original ophthalmic formulation patents	Expired or no longer commercially material
Brand-label exclusivity	Expired
Method-of-use patents	No widely material current barrier identified
Device or container patents	Potentially relevant to a specific supplier, but not a broad product barrier
Manufacturing know-how	May affect quality and cost, but does not block ANDA competition

An Orange Book review should be performed at the specific reference-listed drug level because patent listings can vary by NDA, dosage form, and product sponsor. For the mature fluorometholone products generally sold today, the commercial risk is generic price competition rather than a live composition-of-matter or use patent.

What patents protect sulfacetamide sodium products?

Sulfacetamide sodium also has no commercially meaningful composition-of-matter exclusivity. The active ingredient is old, and generic competition has existed for many years.

Potentially relevant rights are more likely to involve:

• Vehicle composition.
• Sulfur-containing combinations.
• Preservative systems.
• Lotion or cleanser characteristics.
• Packaging and dispensing systems.
• Specific treatment regimens.
• Manufacturing processes.

These rights can protect a particular branded-generic formulation without protecting the active ingredient market as a whole. A formulation patent may support premium pricing only if physicians, pharmacies, or patients regard the product as meaningfully different from lower-cost alternatives.

When do fluorometholone and sulfacetamide sodium lose exclusivity?

Both products have already lost their principal exclusivity. Their current market status is post-exclusivity.

Exclusivity type	Fluorometholone	Sulfacetamide sodium
New chemical entity exclusivity	Expired	Expired
Original NDA exclusivity	Expired	Expired
Basic compound patent	Expired	Expired
Current generic availability	Yes	Yes
Current broad market exclusivity	No	No
Main commercial protection	Supply reliability and formulation know-how	Brand recognition, formulation, and distribution

Paragraph IV litigation is therefore unlikely to be the central market issue for the legacy products. A Paragraph IV filing could arise against a later, reformulated, or newly listed product, but it would not restore exclusivity to the underlying active ingredient.

How many patents cover fluorometholone and sulfacetamide sodium?

There is no commercially meaningful count of unexpired, broad patents covering the active ingredients themselves. Patent counts depend on the scope of the search:

1. Active ingredient patents.
2. Reference-product patents in the Orange Book.
3. Formulation patents.
4. Combination-product patents.
5. Manufacturing patents.
6. Packaging and device patents.
7. Method-of-use patents.
8. Patents owned by suppliers but not asserted against generic applicants.

For investment and licensing purposes, the relevant conclusion is qualitative: the active-ingredient estates are weak, while narrow formulation or process rights may remain relevant to individual products.

What is the Orange Book status of fluorometholone and sulfacetamide sodium?

The Orange Book is most relevant to approved prescription products and their listed patents and exclusivities. Mature fluorometholone and sulfacetamide sodium products generally have no remaining broad patent or regulatory exclusivity that prevents generic substitution.

The Orange Book analysis should distinguish between:

• Reference-listed drugs.
• Authorized generics.
• ANDA-approved copies.
• Combination products.
• Products that have been discontinued but remain listed for reference purposes.
• Products with no active commercial supplier.

A discontinued product can remain relevant to ANDA approval and substitution even when the original brand is no longer widely sold.

What is the financial trajectory for fluorometholone?

Fluorometholone revenue has followed the standard mature-generic trajectory:

1. Original branded sales were protected by historical brand positioning.
2. Generic entry reduced price and shifted volume toward wholesalers, pharmacies, and payer-preferred suppliers.
3. Revenue became distributed among several manufacturers.
4. Product-level margins compressed.
5. Shortages or supplier exits can create temporary price increases.
6. Long-term revenue remains constrained by limited clinical differentiation.

The most defensible financial characterization is stable-to-declining nominal value with episodic volatility. Ophthalmic corticosteroids continue to have recurring demand from ophthalmologists and optometrists, but the market does not support the pricing power associated with newer branded ophthalmic therapies.

Economic value is concentrated in:

• Reliable sterile manufacturing.
• Consistent suspension performance.
• Contract supply arrangements.
• Hospital and clinic formulary access.
• Low-cost packaging.
• Ability to maintain supply during competitor disruptions.

What is the financial trajectory for sulfacetamide sodium?

Sulfacetamide sodium has a broader but more fragmented commercial profile. Ophthalmic products are generally low-price generic medicines. Dermatology products can achieve higher unit economics when sold as branded generics, specialty formulations, or cash-pay products.

The dermatology segment is more exposed to:

• Patient preference.
• Cosmetic acceptability.
• Insurance formulary design.
• Prior authorization.
• Availability of substitutes such as topical antibiotics, retinoids, azelaic acid, benzoyl peroxide, and combination products.
• Dermatology practice prescribing patterns.

Sulfacetamide sodium and sulfur products can retain pricing above simple generic ophthalmic solutions when the product has established brand recognition or a differentiated vehicle. That premium is vulnerable when lower-priced alternatives enter or when payers impose substitution.

What competitive landscape affects these products?

Fluorometholone competitors

Fluorometholone competes with other topical ophthalmic corticosteroids, including:

• Prednisolone acetate.
• Loteprednol etabonate.
• Dexamethasone.
• Rimexolone.
• Difluprednate.
• Combination steroid-antibiotic products.

Prednisolone acetate is a major low-cost comparator. Loteprednol and difluprednate occupy more differentiated, higher-priced positions based on formulation, potency, tolerability, or branded clinical positioning.

Fluorometholone's competitive advantage is its established use and generic pricing. Its weakness is limited differentiation against other corticosteroids.

Sulfacetamide sodium competitors

In ophthalmology, competitors include antibiotic solutions such as polymyxin B combinations, trimethoprim combinations, fluoroquinolones, and erythromycin ointment.

In dermatology, competitors include:

• Benzoyl peroxide.
• Clindamycin.
• Azelaic acid.
• Metronidazole.
• Topical retinoids.
• Dapsone.
• Minocycline and other systemic therapies.
• Sulfur-containing branded generics.

Sulfacetamide sodium's market position depends heavily on the indication. Its role in acne and seborrheic dermatitis is more substitutable than its role in a narrow physician-preferred regimen.

What generic entry risks exist?

Generic entry risk is already realized for both active ingredients. Future commercial risk comes from additional suppliers and product substitution rather than first generic entry.

Risk	Fluorometholone	Sulfacetamide sodium
Additional generic entrants	High	High
Price erosion	High	High
Supply interruption	Moderate	Moderate
Formulation substitution	Moderate	High in dermatology
Patent litigation	Low for legacy products	Low for legacy products
Biosimilar risk	None	None
Brand repricing opportunity	Low	Moderate for differentiated dermatology products

Biosimilar competition is not relevant because both products are small-molecule drugs, not biologics.

What manufacturing and intellectual-property barriers remain?

The strongest practical barriers are operational.

Fluorometholone manufacturing barriers

Sterile ophthalmic suspension manufacturing requires control of:

• Particle-size distribution.
• Homogeneity.
• Sedimentation and redispersion.
• Sterility assurance.
• Fill-volume accuracy.
• Container-closure integrity.
• Preservative concentration.

A supplier with poor batch consistency can lose customers even without patent exposure.

Sulfacetamide sodium manufacturing barriers

The main barriers differ by dosage form. Ophthalmic solutions require sterile processing and stable pH control. Dermatology products require reproducible vehicle manufacture, acceptable sensory properties, and consistent active-ingredient distribution.

These barriers support supplier reliability but rarely create durable legal exclusivity.

What litigation or settlement agreements affect these products?

No broad, current Paragraph IV litigation or settlement structure is central to the legacy fluorometholone or sulfacetamide sodium markets. Product-specific litigation could arise over:

• A newly patented dermatology formulation.
• A combination product.
• A branded-generic reformulation.
• Trade dress or trademark rights.
• Manufacturing defects.
• False advertising.
• ANDA certification disputes.

For mature products, litigation exposure is generally lower than for recently launched ophthalmic drugs with active Orange Book patents.

What licensing deals matter for fluorometholone and sulfacetamide sodium?

Licensing activity is more likely to involve commercialization rights than core patent rights. Potential transaction structures include:

• Acquisition of legacy ophthalmic portfolios.
• In-licensing of dermatology brands.
• Authorized-generic agreements.
• Contract manufacturing.
• Regional distribution rights.
• Product portfolio swaps.

The value of a transaction would depend on net price, prescription volume, manufacturing cost, supply continuity, and the ability to bundle the products with other ophthalmic or dermatology assets. There is limited strategic rationale for licensing the active ingredients alone because broad patent exclusivity has expired.

How do fluorometholone and sulfacetamide sodium compare?

Factor	Fluorometholone	Sulfacetamide sodium
Core therapeutic area	Ophthalmology	Ophthalmology and dermatology
Market maturity	Very mature	Very mature
Patent strength	Weak	Weak at active-ingredient level
Formulation value	Moderate for suspensions	Moderate to high for dermatology vehicles
Pricing power	Low	Low to moderate
Generic pressure	High	High
Supply complexity	Sterile suspension	Sterile solution or topical vehicle
Product differentiation	Limited	Greater in branded dermatology formulations
Biosimilar exposure	None	None
Acquisition appeal	Portfolio add-on	Portfolio add-on, especially dermatology

Key Takeaways

• Fluorometholone and sulfacetamide sodium are post-exclusivity generic medicines.
• Their basic compound and original product patent protection has expired.
• Current commercial value depends on supply reliability, manufacturing quality, distribution, and formulation positioning.
• Fluorometholone is primarily an ophthalmic generic with limited pricing power.
• Sulfacetamide sodium has broader use and greater potential differentiation in dermatology formulations.
• Paragraph IV litigation and settlement agreements are not the main market drivers for the legacy products.
• Biosimilar risk is irrelevant because both drugs are small molecules.
• Financial performance is likely to be stable-to-declining over the long term, with short-term price volatility caused by supplier exits or shortages.
• The strongest acquisition rationale is portfolio consolidation, not ownership of a durable patent moat.

FAQs

Is fluorometholone still commercially attractive?

It can be attractive as a low-cost portfolio product when paired with reliable sterile manufacturing and broad ophthalmic distribution. It has limited standalone pricing power.

Can a company obtain new patents on sulfacetamide sodium?

A company can seek patents on a novel formulation, vehicle, combination, delivery system, or method of use. Those patents would not restore exclusivity to the underlying active ingredient.

Are fluorometholone products interchangeable with prednisolone?

They are in the same broad corticosteroid class but are not automatically interchangeable. Substitution depends on the prescribed product, dosage form, strength, state law, pharmacy rules, and clinician judgment.

Why can an old generic drug experience price increases?

Price increases can follow manufacturer exits, raw-material shortages, sterile manufacturing problems, regulatory actions, or temporary wholesaler inventory constraints.

Do these drugs face generic launch risk from India or China?

They may face competition from manufacturers with global supply chains, including suppliers based in India and China. The commercial effect depends on FDA approval, facility compliance, product availability, and U.S. distribution capacity.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugsatfda
2. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
3. National Library of Medicine. (2024). DailyMed: Fluorometholone ophthalmic products. https://dailymed.nlm.nih.gov/
4. National Library of Medicine. (2024). DailyMed: Sulfacetamide sodium ophthalmic and topical products. https://dailymed.nlm.nih.gov/
5. U.S. Food and Drug Administration. (2024). Generic drug facts. https://www.fda.gov/drugs/generic-drugs
6. U.S. Food and Drug Administration. (2024). Approved drug product list and patent and exclusivity information. https://www.accessdata.fda.gov/scripts/cder/ob/