DIPROLENE Drug Patent Profile

When do Diprolene patents expire, and when can generic versions of Diprolene launch?

Diprolene is a drug marketed by Schering and Organon and is included in four NDAs.

The generic ingredient in DIPROLENE 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

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

Summary for DIPROLENE

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	2
Drug Prices:	Drug price information for DIPROLENE
What excipients (inactive ingredients) are in DIPROLENE?	DIPROLENE excipients list
DailyMed Link:	DIPROLENE at DailyMed

See drug prices for DIPROLENE

Recent Clinical Trials for DIPROLENE

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

Sponsor	Phase
Cairo University	N/A
LEO Pharma	Phase 1

See all DIPROLENE clinical trials

Pharmacology for DIPROLENE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for DIPROLENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986		DISCN	No	No
Organon	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983	AB	RX	Yes	Yes
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991		DISCN	No	No
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988		DISCN	Yes	No

Expired US Patents for DIPROLENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991

International Patents for DIPROLENE

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

Country	Patent Number	Title	Estimated Expiration
Finland	95350
United Kingdom	2140298
Hong Kong	91992	BETAMETHASONE DIPROPIONATE CREAM
Japan	S5356316	SURGICAL OINTMENT FOR TREATING SKIN DESEASE

Market Dynamics and Financial Trajectory for DIPROLENE

Last updated: July 29, 2025

Introduction

DIPROLENE (generic name: betamethasone dipropionate) is a potent topical corticosteroid primarily indicated for inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since its original approval, DIPROLENE has maintained a crucial role within dermatological therapy paradigms. Its market dynamics, influenced by regulatory, clinical, and competitive factors, shape its financial trajectory, offering insight into growth prospects and strategic risks for stakeholders.

Market Landscape and Demand Drivers

The dermatology sector drives significant demand for corticosteroids like DIPROLENE, responding to increasing prevalence of inflammatory skin conditions such as eczema, psoriasis, and dermatitis. The global dermatology market is projected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years, reinforced by rising awareness, aging populations, and expanding access in emerging markets [1].

DIPROLENE's position as a high-potency corticosteroid correlates with clinical efficacy in refractory conditions; however, concerns surrounding long-term use and potential side effects like skin atrophy influence prescribing patterns. Consequently, clinicians balance potency with safety, favoring formulations with favorable risk profiles.

Regulatory and Patent Landscape

DIPROLENE has faced a typical lifecycle pattern of patent protections and subsequent generic entry. Post patent expiry, generic manufacturers rapidly entered the market, intensifying price competition and reducing overall revenue potential for the original patent-holder. The entry of generics has historically driven down prices by 30-50%, impacting profit margins [2].

Recent regulatory updates, including the FDA’s continuous review process and potential new formulations with improved safety profiles, could influence market share dynamics. The absence of recent patent litigation suggests a relatively mature market environment stabilized by existing approvals and standard-of-care positions.

Competitive Dynamics

The corticosteroid segment features a mix of high- and low-potency agents, with competitors such as clobetasol propionate, fluocinonide, and triamcinolone acetonide vying for market share. Biosimilar and generic proliferation further compresses pricing. Additionally, non-steroidal anti-inflammatory topical agents, emollients, and immunomodulators expand therapeutic options, challenging DIPROLENE's dominance in certain indications.

The shift toward newer biologics and targeted therapies for inflammatory dermatoses—especially psoriasis—may indirectly influence DIPROLENE's demand, primarily constraining its use to less severe cases or specific indications.

Pricing Trends and Revenue Outlook

Pricing strategies have shifted due to increased generic competition, with average wholesale prices (AWPs) declining, translating into lower sales revenue per unit. For original manufacturers, this necessitates intensified marketing efforts and formulary positioning to sustain income streams.

Forecasts indicate a gradual decline in DIPROLENE's revenue over the next five years in mature markets due to generics. However, emerging markets present opportunities for growth, driven by expanding healthcare infrastructure and increased dermatologist awareness. Strategic partnerships and market penetration initiatives could augment revenues.

Research and Development Trajectory

While DIPROLENE itself does not currently feature prominent R&D investments, ongoing research into formulations with improved safety profiles, alternative delivery mechanisms (e.g., foam or gel), and combination products could influence its market position. These innovations may command premium pricing and extend lifecycle advantages.

Market Challenges and Opportunities

Key challenges include:

• Safety concerns: Long-term use risks necessitate careful prescribing, limiting broader application.
• Market saturation: Generic competition constrains revenue potential.
• Regulatory pressures: Stringent approval processes for new formulations.

Opportunities involve:

• Formulation innovations: Developing targeted delivery systems or combination therapy options.
• Expanding in emerging markets: Tailored marketing strategies can enhance market share.
• Patient adherence programs: As topical treatments require consistent application, adherence initiatives can boost therapeutic outcomes and market loyalty.

Financial Trajectory Analysis

The revenue lifecycle of DIPROLENE reflects typical patent expiry effects, with initial high-margin sales followed by gradual declines. The original brand’s revenues historically peaked within the first 2-3 years post-launch, then plateaued before declining due to generics. Future financial performance hinges on:

• Market penetration in developing regions.
• Innovations extending product lifecycle.
• Pricing adjustments amidst fierce competition.
• Diversification into novel formulations or combination therapies.

The overall outlook remains cautious; declining revenues are expected as generic competition intensifies. However, strategic diversification and market diversification offer pathways to mitigate revenue erosion.

Conclusion

DIPROLENE's market and financial trajectory exemplifies a mature pharmaceutical product navigating a competitive landscape shaped by patent expiration, safety considerations, and evolving therapeutic alternatives. Its sustained relevance depends on innovation, geographic market expansion, and strategic positioning within dermatological treatment paradigms.

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Key Takeaways

• Market Demographics: Rising dermatological conditions and aging populations sustain demand, but growth is moderated by safety concerns and competition.
• Patent and Competition: Patent expiry led to rapid generic entry, significantly reducing revenue margins.
• Emerging Opportunities: Developing formulations with improved safety profiles and expanding into emerging markets can bolster future revenues.
• Revenue Outlook: Expect a gradual decline in developed markets; diversification efforts are crucial for sustained profitability.
• Innovation and Differentiation: Investment in new formulations and combination therapies critical to extending market relevance.

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FAQs

1. How does the patent status of DIPROLENE affect its market share?
Post-patent expiration, generic manufacturers quickly entered the market, leading to increased competition, lower prices, and reduced brand revenue. Patent protections historically provided a temporary market monopoly, but their expiry facilitates price erosion and market share redistribution.

2. What are the primary clinical considerations influencing DIPROLENE’s demand?
Clinicians prioritize safety due to corticosteroids' side effects like skin atrophy, particularly with high-potency formulations. As a result, DIPROLENE’s use is targeted toward specific severe cases, with safer or less potent agents preferred for long-term management.

3. How do emerging therapies impact DIPROLENE's market potential?
The advent of biologics and targeted immunomodulators offers alternative options for severe inflammatory skin conditions, potentially reducing reliance on topical corticosteroids like DIPROLENE in certain indications.

4. What strategies can manufacturers pursue to maintain profitability?
Innovative formulation development, expanding into emerging markets, strategic marketing, and patient adherence programs are vital. Additionally, pursuing combination therapies or new delivery mechanisms can create differentiation.

5. What is the long-term growth outlook for DIPROLENE?
While sales are expected to decline in mature markets due to generic competition, expanding into developing economies and product line extensions present growth avenues, albeit limited by regulatory and safety considerations.

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Sources
[1] MarketsandMarkets. "Dermatology Drugs Market by Application," 2022.
[2] IQVIA. "Pharmaceutical Pricing and Market Trends," 2022.