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-six 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:	51
Clinical Trials:	2
Patent Applications:	4,859
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
Ireland	843002
Canada	1238276	CREME DE DIPROPIONATE DE BETAMETHASONE (BETAMETHASONE DIPROPIONATE CREAM)
Austria	44462
Denmark	582284
Germany	3478899
New Zealand	210356	TOPICAL WATER-IN-OIL COMPOSITION CONTAINING BETAMETHASONE
European Patent Office	0146065	IMPROVED BETAMETHASONE DIPROPIONATE CREAM

Market Dynamics and Financial Trajectory for DIPROLENE AF

Last updated: February 20, 2026

What is DIPROLENE AF?

DIPROLENE AF (clocortolone pivalate) is a topical corticosteroid indicated for inflammatory and pruritic conditions of the skin, including eczema, dermatitis, and psoriasis. It is marketed as a prescription medication primarily in the United States. The drug is known for its potency, delivering anti-inflammatory effects with a relatively favorable safety profile compared to more potent corticosteroids.

Current Market Position

DIPROLENE AF is marketed under the brand name Diplone, with formulations available as a cream and ointment. It is distributed through major pharmaceutical channels and prescribed by dermatologists and general practitioners. Its presence remains primarily in the North American market, with limited international distribution.

Market Size and Valuation

The global topical corticosteroid market was valued at approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) projected at 4.3% from 2023 to 2030 (Source: MarketsandMarkets [1]). North America accounts for around 45% of market revenue, driven by high prevalence of eczema and psoriasis, advanced healthcare infrastructure, and high drug utilization rates.

Within this segment, DIPROLENE AF has maintained a niche position due to its relatively moderate potency. The drug’s market share faces direct competition from steroids like hydrocortisone, clobetasol, and betamethasone.

Competitive Landscape

Drug/Brand	Potency	Formulations	Market Share (Estimated, 2022)	Key Competitors
DIPROLENE AF	Moderately high	Cream, ointment	5-8%	Elocon, Lidex, cutaneous steroids
Clobetasol Propionate	Very high	Ointment, foam	15-20%	Betamethasone, Triamcinolone
Hydrocortisone	Low	Cream, ointment, lotion	10-15%	Mometasone, Fluocinonide

DIPROLENE AF’s niche is impacted by the presence of high-potency steroids, which can deliver rapid symptom control but carry higher risks of side effects.

Regulatory and Patent Status

DIPROLENE AF received FDA approval in the early 1990s. As of 2023, the patent protection has expired, opening the market for generic formulations. The drug’s brand supply is declining, but generics maintain stable sales due to cost advantages.

Market Drivers

1. Prevalence of Skin Conditions: Eczema affects approximately 10-20% of children and 3% of adults globally [2].
2. Rising Awareness: Improved diagnosis and treatment access contribute to higher prescription rates.
3. Limited Competition in Moderate Potency: Few competitors focus solely on moderate potency corticosteroids, giving DIPROLENE AF a niche.
4. Emerging Biosimilars and Generics: Loss of patent exclusivity has increased competition, lowering prices.

Market Challenges

1. Safety Concerns: Corticosteroid use risks include skin atrophy and systemic absorption, particularly with prolonged use.
2. Preference Shifts: Growing emphasis on non-steroidal topical agents, such as calcineurin inhibitors, reduces reliance on steroids.
3. Pricing Pressure: Generics and biosimilars lower profit margins for branded products.

Financial Trajectory

Sales of DIPROLENE AF have declined gradually over the past five years. The primary revenue sources are prescription renewal and recurring demand from chronic skin condition patients. The expiration of patent protection in 2018 prompted a sharp decline in branded sales, replaced partially by generic versions.

Recent financial data reflects:

Year	Estimated Global Sales (USD millions)	Change YoY	Remarks
2018	50	-15%	Patent expiration led to generic entry
2019	42	-16%	Increased generic competition
2020	38	-10%	Pandemic impact on prescription volumes
2021	35	-8%	Stabilization seen with generics
2022	34	-3%	Market saturation persists

The ongoing trend indicates a plateauing or slight decline. Revenues are likely to stabilize unless new formulations or indications extend market life.

Future Outlook

Possible growth paths involve:

• New Formulations: Development of non-steroidal topical agents that can replace corticosteroids.
• Expanded Indications: Investigating DIPROLENE AF for other dermatological conditions (e.g., lichen planus).
• Regional Expansion: Entering emerging markets where skin disease prevalence is rising and corticosteroid prescriptions are increasing.

Given the saturation and patent expiry, sales are expected to remain flat or decline modestly without significant innovation or market expansion strategies.

Key Takeaways

• DIPROLENE AF holds a niche market among moderate potency topical corticosteroids.
• The expiration of patent rights in 2018 led to price competition from generics.
• The market is mature, with sales stabilized at a reduced level.
• Growth hinges on innovation, expanding indications, or regional penetration.
• Competitive threats include safety concerns and shifting preference toward steroid-sparing agents.

FAQs

Q1: Will DIPROLENE AF gain market share with new formulations?
A1: Unlikely; unless new formulations demonstrate superior safety or efficacy, market share gains are limited due to existing competition and safety preferences.

Q2: How does the sale of DIPROLENE AF compare to high-potency corticosteroids?
A2: Its sales are lower, attributed to a smaller niche focus, as high-potency steroids dominate for severe cases.

Q3: What impact does patent expiry have on DIPROLENE AF sales?
A3: It increases price competition from generics, leading to a decline in branded sales and lower profit margins.

Q4: Are biosimilars relevant for topical corticosteroids like DIPROLENE AF?
A4: Biosimilars are less relevant; topical corticosteroids are small-molecule drugs, and biosimilars generally apply to biologics.

Q5: Which regions offer growth opportunities for corticosteroid products?
A5: Emerging markets in Asia-Pacific, Latin America, and parts of Africa show increasing demand due to rising skin condition prevalence.

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References

[1] MarketsandMarkets. (2023). Topical Corticosteroids Market by Type and Region: Global Forecast 2023–2030.

[2] National Eczema Association. (2022). Facts and Statistics about Eczema.