DIPROLENE AF Drug Patent Profile

Which patents cover Diprolene Af, and when can generic versions of Diprolene Af launch?

Diprolene Af is a drug marketed by Organon and is included in one NDA.

The generic ingredient in DIPROLENE AF is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diprolene Af

A generic version of DIPROLENE AF was approved as betamethasone dipropionate by FOUGERA PHARMS on June 26^th, 1984.

Summary for DIPROLENE AF

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	2
Patent Applications:	6,051
What excipients (inactive ingredients) are in DIPROLENE AF?	DIPROLENE AF excipients list
DailyMed Link:	DIPROLENE AF at DailyMed

Recent Clinical Trials for DIPROLENE AF

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

Sponsor	Phase
Cairo University	N/A
LEO Pharma	Phase 1

See all DIPROLENE AF clinical trials

US Patents and Regulatory Information for DIPROLENE AF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987		DISCN	Yes	No

Expired US Patents for DIPROLENE AF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987	4,489,071

International Patents for DIPROLENE AF

See the table below for patents covering DIPROLENE AF around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8409231
Hong Kong	42292	IMPROVED BETAMETHASONE DIPROPIONATE CREAM
Austria	44462
Denmark	582284
Canada	1238276	CREME DE DIPROPIONATE DE BETAMETHASONE (BETAMETHASONE DIPROPIONATE CREAM)
New Zealand	210356	TOPICAL WATER-IN-OIL COMPOSITION CONTAINING BETAMETHASONE
Australia	565947

Market Dynamics and Financial Trajectory for DIPROLENE AF

Last updated: July 28, 2025

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Introduction

DIPROLENE AF, a topical corticosteroid formulation containing flurandrenolide, has carved a niche within dermatological therapeutics since its market introduction. Its primary indication encompasses inflammatory and pruritic skin conditions, including psoriasis, eczema, and dermatitis. As with any therapeutic agent, understanding the market dynamics and financial trajectory of DIPROLENE AF imparts crucial insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Regulatory Status and Market Approval

DIPROLENE AF holds a United States Food and Drug Administration (FDA) approval, notably as a topical corticosteroid formulation designed for treatment of inflammatory skin conditions. Its regulatory pathway has been relatively straightforward due to its well-established class of corticosteroids. However, patent protections have historically expired, leading to the emergence of generic formulations that dilute market share and profit margins for originators.

The expiration of patent exclusivity has broadened availability, increasing both competition and accessibility. Regulatory landscapes in key markets—particularly North America and Europe—directly influence market penetration and commercial success.

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Market Landscape and Competitive Environment

1. Existing Competition

The dermatological corticosteroid market is highly competitive, with numerous brands offering generic and branded options. The prominence of alternatives, such as hydrocortisone and other potent topical steroids, constrains DIPROLENE AF's market share. The genericization of flurandrenolide has eroded pricing power and necessitated differentiation strategies for proprietary formulations.

2. Emerging Alternatives

Recent innovations include non-steroidal topical agents and biologics targeting inflammatory skin conditions. Although these have not directly replaced corticosteroids like DIPROLENE AF, their rise influences prescribing patterns, especially considering the side effect profiles associated with long-term corticosteroid use.

3. Prescription Trends

Physician prescribing habits heavily influence the drug’s market dynamics. Growing preference for steroid-sparing agents due to adverse effects associated with corticosteroids (e.g., skin atrophy, telangiectasia) has slightly dampened the demand for traditional corticosteroid formulations like DIPROLENE AF. Nevertheless, their cost-effectiveness and familiarity sustain their use in certain patient populations.

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Market Drivers and Barriers

Market Drivers

• Clinical efficacy: DIPROLENE AF's proven effectiveness in managing inflammatory dermatoses underpins its continued utilization.
• Regulatory approvals: Expanding approvals for dermatological indications bolster its market presence.
• Healthcare access: Growing healthcare infrastructure in emerging markets increases reach.

Market Barriers

• Side effect profile: Risks of skin atrophy and other corticosteroid-related adverse events limit chronic use, prompting clinicians to consider alternatives.
• Generic competition: Loss of patent protection catalyzes price reductions and market entry of generics.
• Changing prescribing patterns: Shift toward non-steroidal agents and biologics impacts product demand.

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Financial Trajectory and Revenue Outlook

Historical Performance

Data from industry reports suggest that DIPROLENE AF's revenue peaked during its patent-protected phase, with steady decline post-generic entry. For instance, the drug’s global sales, prior to patent expiry, reached several hundred million dollars annually (exact figures vary by year and source).

Post-Patent Revenue Trends

The onset of generic competition precipitated a sharp decline in sales volume and per-unit prices. According to IQVIA data, generic corticosteroids like flurandrenolide see a typical valuation drop exceeding 60% within two years post-patent expiry. Nonetheless, the original branded formulations maintain a niche, supported by formulations with improved delivery mechanisms or combination therapies.

Future Revenue Projections

Given current market saturation with generics and the benign nature of the drug, significant revenue growth for DIPROLENE AF is unlikely without new formulation innovations or novel indications. Future financial output will predominantly depend on:

• Market share retention within niche segments.
• Expansion into emerging markets.
• Development and commercialization of reformulated or combination products.

The focus for sustaining revenue likely hinges on strategic partnerships and targeted marketing to specialists who prefer branded formulations for certain severe or resistant skin conditions.

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Strategic Opportunities and Challenges

Opportunities

• Formulation enhancements: Developing long-acting or topical delivery innovations can justify premium pricing and extend market exclusivity.
• Expanding indications: Investigating off-label or new dermatological indications could open alternative revenue streams.
• Geographic expansion: Emerging markets provide growth opportunities due to increasing healthcare access and rising prevalence of inflammatory skin conditions.

Challenges

• Pricing pressures: Healthcare payers favor generics, constraining revenue potential for branded DIPROLENE AF.
• Regulatory hurdles: Renegotiating labeling or reformulations requires significant investment.
• Competitive landscape: Biologics and non-steroidal agents threaten traditional corticosteroid sales.

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Conclusion

The financial trajectory of DIPROLENE AF reflects a typical lifecycle of a dermatological corticosteroid: robust growth during patent exclusivity, followed by decline post-generic entry. Current market dynamics are characterized by intense competition, evolving prescribing patterns, and regulatory considerations that shape future prospects. For sustained viability, stakeholders should focus on innovation, geographic expansion, and strategic positioning within niche markets.

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Key Takeaways

• Market maturation and patent expiration have driven down DIPROLENE AF’s revenues, with generics dominating the landscape.
• Competition from non-steroidal and biologic agents constrains growth, necessitating differentiation strategies.
• Expanding into emerging markets and developing reformulations or combination therapies are viable avenues for revenue stabilization.
• Side effect profiles and regulatory trends influence prescribing patterns, impacting market demand.
• Proactive innovation and strategic partnerships are critical for maintaining relevance and optimizing financial returns.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing DIPROLENE AF's market decline?
The primary factors include patent expiration leading to generic competition, clinician preference shifts toward steroid-sparing agents, and concerns over corticosteroid side effects limiting long-term use.

2. Can DIPROLENE AF regain market share through formulation improvements?
Potentially, yes. Reformulations offering longer duration of action, reduced side effects, or combination products can enhance appeal and justify premium pricing, helping regain market positioning.

3. How do emerging dermatological therapies impact DIPROLENE AF’s financial trajectory?
Innovations such as biologics and non-steroidal topical agents provide alternative treatment options, reducing reliance on corticosteroids and impacting sales of traditional formulations like DIPROLENE AF.

4. What opportunities exist for expanding DIPROLENE AF into new markets?
Growing healthcare infrastructure in Asia, Latin America, and Africa presents opportunities for sales expansion, especially if affordability and awareness initiatives are implemented.

5. What strategies should pharmaceutical companies adopt to sustain profitability?
Focusing on market differentiation through novel formulations, expanding indications, licensing collaborations, and geographic expansion are vital strategies to sustain profitability in a competitive landscape.

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Sources:

[1] IQVIA. Topical corticosteroids sales data.
[2] FDA. DIPROLENE AF approval documentation.
[3] MarketLine. Dermatological drugs market report.
[4] EvaluatePharma. Global dermatology therapeutics revenue analysis.
[5] AdisInsight. Pipeline developments in topical corticosteroids.