diflorasone diacetate - Profile

What are the generic sources for diflorasone diacetate and what is the scope of patent protection?

Diflorasone diacetate is the generic ingredient in five branded drugs marketed by Ani Pharms, Avondale Pharms, Sun Pharma Canada, Pfizer, Taro Pharms North, Rising, Sciegen Pharms, and The J Molner, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for diflorasone diacetate

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	13

US Patents and Regulatory Information for diflorasone diacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	CREAM;TOPICAL	076263-001	Dec 20, 2002		DISCN	No	No
Avondale Pharms	DIFLORASONE DIACETATE	diflorasone diacetate	CREAM;TOPICAL	075187-001	Mar 30, 1998		DISCN	No	No
Sun Pharma Canada	DIFLORASONE DIACETATE	diflorasone diacetate	CREAM;TOPICAL	075508-001	Apr 24, 2000	BX	RX	No	Yes
Pfizer	FLORONE	diflorasone diacetate	CREAM;TOPICAL	017741-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985		DISCN	No	No

Expired US Patents for diflorasone diacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLORONE	diflorasone diacetate	CREAM;TOPICAL	017741-001	Approved Prior to Jan 1, 1982	3,980,778
Pfizer	PSORCON	diflorasone diacetate	OINTMENT;TOPICAL	019260-001	Aug 28, 1985	3,980,778
Pfizer	PSORCON E	diflorasone diacetate	OINTMENT;TOPICAL	017994-001	Approved Prior to Jan 1, 1982	3,980,778
Pfizer	FLORONE E	diflorasone diacetate	CREAM;TOPICAL	019259-001	Aug 28, 1985	3,980,778

Diflorasone Diacetate Investment Analysis: Patent Position, FDA Status, Market Fundamentals, and Generic Risk

Last updated: July 31, 2026

Diflorasone diacetate is a mature, generic topical corticosteroid with limited standalone investment value. The active ingredient is a high-potency topical glucocorticoid used for inflammatory dermatoses, including psoriasis and corticosteroid-responsive dermatitis. Its core composition-of-matter protection expired long ago, and commercial competition is primarily based on manufacturing cost, pharmacy access, contract supply, and retailer or insurer formularies rather than patent exclusivity.

The investment case is therefore a generic-manufacturing and product-portfolio question. Diflorasone diacetate may contribute incremental revenue to a dermatology or topical-generic manufacturer, but it is unlikely to support material pricing power, licensing value, or litigation-driven upside.

What is diflorasone diacetate used for?

Diflorasone diacetate is a topical corticosteroid marketed in cream and ointment formulations, generally at a 0.05% strength. FDA labeling classifies it as a high- or super-high-potency topical corticosteroid, depending on the formulation and potency classification used by the product label.[1]

Typical labeled uses include:

• Psoriasis
• Atopic dermatitis
• Contact dermatitis
• Other corticosteroid-responsive inflammatory skin conditions

The product is intended for topical administration. It is not interchangeable with systemic corticosteroids, injectable corticosteroids, or biologic psoriasis treatments such as adalimumab, ustekinumab, secukinumab, or deucravacitinib.

How does diflorasone compare with other topical steroids?

Product	Typical potency category	Common dosage forms	Commercial position
Diflorasone diacetate 0.05%	High to super-high potency	Cream, ointment	Mature generic
Clobetasol propionate 0.05%	Super-high potency	Cream, ointment, solution, foam, shampoo	Larger generic market and broader dosage-form competition
Betamethasone dipropionate 0.05%	High to super-high potency	Cream, ointment, lotion, augmented formulations	Broad generic competition
Fluocinonide 0.05%	High potency	Cream, ointment, gel, solution	Established generic
Triamcinolone acetonide	Medium to high potency depending on formulation	Cream, ointment, lotion, spray	Much broader use and larger volume
Hydrocortisone	Low potency	Cream, ointment, lotion	Very large over-the-counter and prescription market

Diflorasone competes with other topical corticosteroids on potency, tolerability, physician familiarity, availability, and formulary position. It does not have the breadth of use or commercial scale of hydrocortisone, triamcinolone acetonide, or clobetasol propionate.

What is the FDA regulatory status of diflorasone diacetate?

Diflorasone diacetate is an FDA-approved prescription topical corticosteroid. Approved products have been marketed under brand and generic names, including products associated with the Apexicon and Psorcon franchises and later generic equivalents.[1][2]

FDA approval is generally obtained through:

• A full new drug application for an original branded product
• An abbreviated new drug application for a generic equivalent
• Supplemental filings covering manufacturing, labeling, or dosage-form changes

The current regulatory opportunity is primarily generic. There is no apparent regulatory exclusivity comparable to a new chemical entity, orphan drug, pediatric extension, or innovative dermatology delivery platform.

What is the Orange Book status of diflorasone diacetate?

The FDA Orange Book identifies approved drug products and, where applicable, listed patents and exclusivity periods.[3] Diflorasone diacetate products are generally treated as mature prescription products with no meaningful remaining composition-of-matter exclusivity.

For investment analysis, the relevant Orange Book conclusions are:

Issue	Assessment
New chemical entity exclusivity	Expired
Core composition-of-matter protection	Expired
Active FDA approval pathway	Generic and legacy branded products
Current patent-driven pricing power	Minimal
Relevant regulatory barrier	ANDA approval, manufacturing compliance, supply continuity
Biosimilar pathway	Not applicable

Orange Book status can vary by product, manufacturer, dosage form, and listing history. A specific product-level determination requires review of the current FDA listing for the relevant applicant and strength.

What patents protect diflorasone diacetate?

The active ingredient is an old corticosteroid compound. Any original compound patents and early formulation patents would have expired many years ago. Diflorasone diacetate therefore has no credible remaining composition-of-matter patent moat.

Potential historical patent categories include:

1. The diflorasone chemical entity or ester form.
2. Topical cream or ointment formulations.
3. Manufacturing processes.
4. Therapeutic use claims.
5. Packaging or delivery systems.

The commercial significance of those categories is limited because topical corticosteroid products have been available for decades and the underlying technology is well established.

How strong is the diflorasone diacetate patent estate?

The patent estate is weak from an investment perspective.

Patent factor	Investment assessment
Composition-of-matter patent	Expired
Broad method-of-use claims	Expired or commercially ineffective
Formulation claims	Limited value unless tied to a differentiated product
Manufacturing patents	Possible but narrow and generally non-blocking
Device or delivery patents	Not central to standard cream or ointment products
Patent litigation leverage	Low
Generic entry protection	None of material duration

A manufacturer could obtain patents on a novel vehicle, emulsion, foam, spray, or controlled-delivery system. Such patents would protect the specific formulation rather than diflorasone diacetate itself. A conventional cream or ointment would face substantial invalidity and obviousness risk if it attempted to rely on broad legacy claims.

What formulations are protected by diflorasone diacetate patents?

Standard diflorasone diacetate formulations include cream and ointment products at a 0.05% concentration. The key technical variables are:

• Vehicle composition
• Drug particle size
• Solubilization or suspension method
• Preservative system
• Emulsion stability
• Occlusiveness
• Skin penetration
• Container and closure system
• Microbial control

These variables can create formulation-specific intellectual property, but they do not create broad exclusivity around the active ingredient. A topical formulation patent must generally show a meaningful technical distinction, such as improved stability, enhanced penetration, reduced irritation, or clinically relevant performance.

For ordinary generic products, the major barriers are formulation development, analytical equivalence, scale-up, and FDA inspection readiness. Those barriers are operational rather than patent-based.

When does diflorasone diacetate lose exclusivity?

Diflorasone diacetate lost its meaningful brand exclusivity decades ago. The product is now in the post-exclusivity generic phase.

Milestone	Approximate status
Original drug development	Historical
Original FDA approval	Historical, predating the modern generic market
New chemical entity exclusivity	Expired
Original compound patent	Expired
ANDA competition	Established
Current commercial phase	Mature generic

A precise expiration date for the original patent is not central to the investment case because the product has already passed the period in which patent expiration would materially change market structure.

Which companies manufacture diflorasone diacetate?

Manufacturing and marketing have shifted among dermatology companies and generic pharmaceutical suppliers. Public product databases and FDA labeling records have associated diflorasone diacetate products with manufacturers or labelers including Taro Pharmaceuticals and other generic or specialty-pharma companies.[1][2]

The market is fragmented by:

• National generic suppliers
• Specialty dermatology companies
• Contract manufacturers
• Pharmacy benefit formulary suppliers
• Retail and mail-order distributors

Labeler identity does not always equal manufacturing identity. A company may own the application, outsource production, or distribute a product manufactured by another approved facility.

What competitive advantages matter?

The relevant competitive advantages are:

• Reliable API sourcing
• Low-cost topical manufacturing
• Consistent batch release
• High-quality tube and packaging supply
• Retail and wholesale distribution
• Low back-order frequency
• Formulary access
• Ability to maintain multiple topical products in a portfolio

A supplier with diflorasone diacetate plus clobetasol, betamethasone, fluocinonide, and triamcinolone products may obtain portfolio efficiencies. Diflorasone by itself is unlikely to provide material bargaining power.

Are there Paragraph IV challenges for diflorasone diacetate?

Paragraph IV litigation is generally associated with an ANDA applicant asserting that listed patents are invalid, unenforceable, or not infringed under the Hatch-Waxman framework.[4]

Diflorasone diacetate has limited Paragraph IV relevance because:

• The original product is old.
• Core patents have expired.
• Standard generic cream and ointment formulations are established.
• There is no widely recognized current patent thicket comparable to newer dermatology products.
• Any dispute would likely concern a specific branded formulation or later-added product patent.

A Paragraph IV filing could arise against a newly approved branded formulation, but that would be a product-specific event rather than a challenge to the mature active ingredient.

What patent litigation affects diflorasone diacetate?

There is no major current litigation theme associated with diflorasone diacetate comparable to the litigation surrounding high-value small molecules, biologics, inhaled products, or complex injectables. The principal legal risks are ordinary generic-pharmaceutical risks:

• ANDA patent disputes involving a specific formulation
• FDA inspection or manufacturing findings
• Labeling disputes
• Product-liability claims
• Antitrust claims involving supply or contracting practices
• Trademark disputes involving legacy brands

The absence of a major patent case reduces legal uncertainty but also removes the possibility of a litigation-driven commercial premium.

What generic entry risks exist for diflorasone diacetate?

Generic entry risk is already embedded in the market structure. Additional entrants can produce:

• Price erosion
• Pharmacy substitution
• Lower wholesaler purchasing prices
• Reduced manufacturer margins
• Inventory volatility
• Contract loss
• Short-term shortages followed by rapid re-entry

The risk is higher when several approved applicants have available capacity and the product has a simple topical formulation. It is lower when only a small number of manufacturers remain active or when API, tube, or plant capacity is constrained.

Diflorasone is not a biologic and has no biosimilar risk. It is a conventional small-molecule topical product. FDA approval does not require the complex comparability program associated with biosimilar development under the Public Health Service Act.[5]

What is the revenue exposure for diflorasone diacetate?

Standalone revenue data are generally not disclosed by manufacturers because diflorasone diacetate is usually reported within broader dermatology or generic-drug segments.

The commercial profile is likely characterized by:

• Low absolute revenue per product
• Low to moderate unit demand
• Generic price pressure
• Limited promotional spending
• Small contribution to diversified manufacturers
• High sensitivity to supply interruptions
• Greater value as part of a dermatology portfolio than as a standalone asset

A company evaluating acquisition or licensing should not underwrite material value from diflorasone sales without verified data on prescription volume, net price, gross-to-net deductions, manufacturer share, supply contracts, and product profitability.

What would improve the investment case?

The product could have higher strategic value if attached to:

• A differentiated vehicle
• A patented delivery system
• A combination product
• An authorized generic arrangement
• A supply-constrained market
• A specialty-pharmacy distribution model
• A larger dermatology portfolio
• Manufacturing capacity that supports several topical products

Without one of those features, the asset is a low-growth generic rather than a platform product.

How does diflorasone compare with newer dermatology drugs?

Attribute	Diflorasone diacetate	New topical nonsteroidals	Biologic psoriasis drugs
Drug class	Corticosteroid	PDE-4, JAK, aryl hydrocarbon receptor, or other class	Monoclonal antibody
FDA pathway	Legacy NDA and ANDA	Modern NDA	BLA
Patent position	Weak or expired	Often active	Often active
Pricing power	Low	Moderate to high if differentiated	High
Safety monitoring	Topical steroid limitations	Product-specific	Systemic and immunologic monitoring
Biosimilar exposure	None	None	Increasing
Commercial growth	Mature or declining	Potential growth	Large specialty market
Investment profile	Generic cash flow	Innovation-driven	Patent and biologic lifecycle-driven

Diflorasone remains clinically useful where high-potency topical corticosteroid treatment is appropriate. Its low price and established physician familiarity support continued demand, but those same characteristics limit the ability to raise prices or sustain premium margins.

What licensing deals exist for diflorasone diacetate?

No major current licensing transaction is central to the diflorasone diacetate market. Legacy brand rights and generic marketing authorizations may have changed hands, but these arrangements are generally commercial supply or product-acquisition transactions rather than high-value discovery licenses.

A transaction involving the product should be assessed through:

• Net sales by dosage form
• Gross margin after rebates and chargebacks
• Active ANDA ownership
• FDA inspection history
• API source qualification
• Product complaint rates
• Back-order history
• Remaining customer contracts
• Manufacturing cost per tube
• Number of active competitors

The license value of an old topical steroid is usually tied to cash flow and supply reliability, not patent duration.

What generic launch scenarios are most likely?

Three scenarios are commercially relevant.

Base case: stable low-margin supply

Existing generic suppliers continue selling cream and ointment products. Volume remains stable, but net prices decline gradually. The product provides modest recurring revenue to manufacturers with low operating costs.

Downside case: additional competition

A new ANDA entrant or returning supplier increases price competition. Wholesaler and pharmacy pricing falls, and smaller suppliers exit because the product cannot support adequate margins.

Upside case: supply disruption or differentiated formulation

A competitor experiences a manufacturing or API problem, creating temporary scarcity. Alternatively, a company launches a differentiated vehicle with improved usability or tolerability. The benefit would likely be temporary for a conventional generic and more durable only if supported by enforceable formulation claims and clinical differentiation.

What geographic coverage does diflorasone diacetate have?

The United States is the principal jurisdiction for an Orange Book and ANDA analysis. Patent and regulatory status outside the U.S. must be assessed separately because:

• Patent terms differ by country.
• Marketing authorizations are jurisdiction-specific.
• Product names vary.
• Generic substitution rules differ.
• Pricing and reimbursement systems differ.
• Some countries may not have the same formulation or dosage-form approvals.

For a global commercial assessment, the relevant markets are likely to be regulated generic markets in North America, Europe, and selected emerging markets. Geographic value depends more on registration status and distribution than on patent protection.

What are the manufacturing and intellectual-property barriers?

Manufacturing barriers are moderate but manageable. A company must demonstrate:

• Validated topical manufacturing processes
• Consistent potency and uniformity
• Microbial control
• Stability through the proposed shelf life
• Container-closure compatibility
• Reliable API supply
• Compliance with current good manufacturing practice requirements

The intellectual-property barriers are low for conventional cream and ointment products. Manufacturing know-how can still create a practical barrier, especially when the product has a small market and low expected return. That barrier is vulnerable to new entrants with existing dermatology facilities.

Key Takeaways

• Diflorasone diacetate is a mature, generic topical corticosteroid with no meaningful remaining composition-of-matter exclusivity.
• The FDA pathway is established, and standard products are generally cream or ointment formulations at 0.05%.
• Orange Book and Paragraph IV issues are product-specific and unlikely to create broad market protection.
• Biosimilar risk does not apply because diflorasone diacetate is a conventional small molecule.
• Revenue is likely modest and usually embedded in broader dermatology or generic portfolios.
• The main investment risks are price erosion, additional generic entry, supply disruption, FDA manufacturing issues, and weak product differentiation.
• The strongest commercial thesis is low-cost, reliable supply or a differentiated topical formulation, not patent-led pricing power.
• An acquisition or licensing valuation should rely on verified net sales, margin, competitive count, supply contracts, and regulatory status.

FAQs

Is diflorasone diacetate still under patent?

No material composition-of-matter protection remains for the mature active ingredient. Any relevant current patents would likely cover a specific formulation, delivery system, or product configuration.

Is diflorasone diacetate a biologic?

No. Diflorasone diacetate is a conventional small-molecule topical corticosteroid and is approved through drug-product pathways rather than the biologics licensing pathway.

Can a generic manufacturer launch diflorasone diacetate without Paragraph IV litigation?

Yes, if no unexpired, applicable patent blocks the relevant product or if the applicant uses a certification strategy that does not trigger a patent dispute. The exact analysis depends on the product-specific Orange Book record.

Does diflorasone diacetate have high commercial growth potential?

No. It is a mature generic with limited standalone growth potential. Growth would most likely come from a supply disruption, portfolio expansion, or a differentiated formulation.

What is the main investment risk for a diflorasone diacetate supplier?

The main risk is margin compression caused by additional generic competition. Regulatory manufacturing problems and API supply interruptions are also material because a small product can lose customers quickly after prolonged unavailability.

References

1. U.S. Food and Drug Administration. (n.d.). Diflorasone diacetate cream and ointment prescribing information. DailyMed/FDA labeling records.

2. National Library of Medicine. (n.d.). Diflorasone diacetate drug labels and product information. DailyMed.

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugsatfda

4. U.S. Food and Drug Administration. (2017). Thirty years of the Hatch-Waxman Amendments: A regulatory framework for generic drug competition. FDA.

5. U.S. Food and Drug Administration. (n.d.). Biosimilar and interchangeable products. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars-addressing-questions-and-answers-references-controls-and-labeling