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 is one drug master file entry for this compound. Twenty-seven 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 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
Patent Applications:	6,432
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
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987		DISCN	Yes	No

Expired US Patents for DIPROLENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Organon	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986

International Patents for DIPROLENE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2999177
Australia	509635
Belgium	860071
Switzerland	627652	Topical ointment
Germany	2747631
Denmark	152171

Market Dynamics and Financial Trajectory for Diprolene

Last updated: March 13, 2026

What is the current market positioning of Diprolene?

Diprolene (fluocinonide) is a high-potency topical corticosteroid indicated for treating inflammatory and pruritic conditions such as psoriasis, eczema, and dermatitis. Its global market is driven by increasing prevalence of dermatological conditions, especially in aging populations.

Key Data:

• Indications: Psoriasis, eczema, dermatitis.
• Formulation strengths: 0.05% cream, ointment, and gel.
• Market size estimates: The global corticosteroid market was valued at approximately USD 5.8 billion in 2022, projected to grow at a Compound Annual Growth Rate (CAGR) of 4.2% through 2030 [1].

What factors influence Diprolene’s market growth?

Increasing dermatology disease prevalence

Rising cases of psoriasis and atopic dermatitis globally. The National Psoriasis Foundation reports over 8 million Americans affected [2].

Competitive landscape

Diprolene faces competition from:

• Generic corticosteroids (e.g., clobetasol, betamethasone).
• Fixed-dose combination products.
• Emerging biologics for severe cases, such as adalimumab.

Regulatory environment

• US FDA approvals for new formulations or indications can expand market share.
• Biosimilar and generic entry exert downward pressure on prices.

Pricing and reimbursement

• Pricing varies regionally; premium prices are maintained in developed markets.
• Reimbursement policies influence prescription patterns and sales volume.

How are sales and revenue trends expected to evolve?

While specific Diprolene sales figures are not publicly disclosed, industry reports suggest:

• The corticosteroid segment's growth correlates with dermatology market trends.
• Brands with strong physician preference and patent protection maintain higher margins.
• Price erosion occurs due to generic competition, a typical trajectory within 3–5 years of patent expiry.

Sales pattern assumptions:

Year	Estimated global sales (USD millions)	Remarks
2022	150-200	Steady demand in developed markets
2023	140-190	Slight decline due to generics
2024	130-180	Increased generic competition
2025+	Stabilization or decline	Market saturation, biosimilars

What future development opportunities exist for Diprolene?

• Novel formulations: Extended-release or combination therapies.
• Indication expansion: Potential for use in other inflammatory skin conditions.
• Geographic growth: Asia-Pacific and Latin America show increasing dermatology disease burden and insurance coverage improvements.

What risks could impact Diprolene's financial trajectory?

• Patent expiration: Leads to increased generic competition and reduced pricing.
• Regulatory hurdles: Delays or rejections for new formulations or indications.
• Market saturation: High existing penetration limits growth potential.
• Pricing pressures: Payers negotiate discounts or favor biosimilars.

Summary

Diprolene maintains a position within the corticosteroid market driven by dermatology disease prevalence. Its revenue trajectory faces decline post-patent expiry due to generic competition but can be offset through formulation innovation, indication expansion, and growth in emerging markets. The overall corticosteroid sector is expected to grow moderately, influenced by new product developments and regional health trends.

Key Takeaways

• Diprolene holds a significant share in the topical corticosteroid segment but faces patent cliffs.
• Market expansion hinges on dermatology disease trends and regulatory actions.
• Price competition and generics exert downward pressure on revenue.
• Future growth opportunities lie in formulation improvements and geographically expanding beyond mature markets.
• Risks include patent expiry, regulatory delays, and market saturation.

FAQs

1. When does Diprolene's patent expire?
   Patent patents for the original formulation expired or are nearing expiry in key markets, generally between 2023–2025, depending on jurisdiction.

2. How does generic competition affect Diprolene sales?
   Generics typically enter within three to five years after patent expiration, reducing brand sales and pressure on pricing.

3. Are there biosimilars or biologics competing with Diprolene?
   No, biosimilars target biologics, while Diprolene is a topical corticosteroid; competition from biologics is limited to systemic treatments.

4. What are potential markets for expansion?
   Asia-Pacific and Latin America are emerging markets with increasing dermatological condition prevalence and improving healthcare infrastructure.

5. What recent approvals could impact Diprolene's market?
   No recent major approvals have been announced; future approvals could influence formulations or indications, affecting competitive positioning.

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References:

[1] MarketsandMarkets. (2022). Corticosteroids Market Analysis.
[2] National Psoriasis Foundation. (2022). Psoriasis Prevalence Data.

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