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-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

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
Patent Applications:	5,211
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

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

International Patents for DIPROLENE

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	91992	BETAMETHASONE DIPROPIONATE CREAM
Sweden	432052	FORFARANDE FOR FRAMSTELLNING AV EN TOPISK SALVA FOR BEHANDLING AV DERMATOLOGISKA AKOMMOR SAMT SALVBAS TILL ANVENDNING SOM MEDEL VID FORFARANDET
Japan	2572124

DIPROLENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DIPROLENE

Introduction to DIPROLENE

DIPROLENE, known by its generic name as augmented betamethasone dipropionate, is a super-high potency topical corticosteroid used to treat various skin conditions characterized by inflammation and itching, such as eczema, psoriasis, and atopic dermatitis[4,.

Market Overview

The topical drug delivery market, which includes products like DIPROLENE, is experiencing significant growth driven by several key factors.

Increasing Incidences of Skin Diseases

The rising prevalence of skin diseases such as psoriasis, eczema, and atopic dermatitis is a major driver for the demand of topical corticosteroids like DIPROLENE. As the global population ages and urbanizes, the incidence of these conditions is expected to increase, thereby boosting the market for topical treatments[3].

Rising Preference for Non-Invasive Therapeutics

There is a growing preference for non-invasive treatment methods, which has led to an increased demand for topical drug delivery systems. Patients and healthcare providers are opting for treatments that are less invasive and have fewer systemic side effects, making topical corticosteroids like DIPROLENE more appealing[3].

Technological Advancements

Advancements in drug formulations and delivery systems are enhancing the efficacy and safety of topical corticosteroids. For example, the augmented formulation of DIPROLENE, which includes propylene glycol, helps the drug penetrate the skin more quickly and be absorbed more effectively[4].

Market Size and Growth Projections

The global topical drug delivery market, which includes DIPROLENE, was valued at USD 109.16 billion in 2024 and is projected to reach USD 177.97 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.3% from 2024 to 2031. This growth is driven by the increasing demand for localized treatment options and the advancements in drug delivery technologies[3].

Competitive Landscape

The market for topical corticosteroids is competitive, with several key players including Hisamitsu Pharmaceuticals, Bayer AG, Novartis AG, Galderma Holding SA, GlaxoSmithKline PLC, Johnson & Johnson Private Limited, Bausch Health Companies Inc., Cipla Limited, and 3M Company. These companies are involved in strategic collaborations, product innovations, and market expansions to maintain their market share[3].

Regional Analysis

The market for topical drug delivery systems is geographically diverse, with high-growth regions including North America, Europe, and the Asia-Pacific (APAC) region. The APAC region is particularly significant due to its large population and increasing healthcare expenditure, which drives the demand for advanced topical treatments[3].

Regulatory Landscape

The regulatory environment plays a crucial role in the development and market expansion of topical corticosteroids. Regulatory bodies such as the FDA closely monitor the safety and efficacy of these products. For DIPROLENE, regulatory guidelines emphasize the need for careful patient monitoring, especially in pediatric patients, due to the risk of HPA axis suppression and other systemic side effects[5].

Financial Implications

Cost and Pricing

The cost of DIPROLENE can vary depending on the formulation (cream, ointment, or gel) and the region. However, it is generally considered a high-potency corticosteroid that requires a prescription, which can impact its pricing. The financial strain on patients can be significant, especially for those without adequate health insurance coverage[2].

Savings Through Generic Versions

DIPROLENE cream is available as a generic under the name augmented betamethasone propionate cream, which can offer cost savings for patients. Generic versions often have lower prices compared to brand-name products, making them more accessible to a wider population[4].

Impact on Healthcare Systems

The use of topical corticosteroids like DIPROLENE can have downstream economic consequences on healthcare systems. While these treatments can reduce the need for more invasive and costly procedures, they also require careful monitoring and potential adjustments in treatment plans to avoid systemic side effects. This can influence healthcare resource allocation and overall healthcare costs[2].

Patient and Healthcare Provider Perspectives

Efficacy and Safety

Healthcare providers and patients appreciate the efficacy of DIPROLENE in treating skin conditions. However, there is a need for careful monitoring due to the potential for systemic side effects, particularly in pediatric patients. The risk of HPA axis suppression and adrenal insufficiency is higher in younger age groups, necessitating cautious use and regular follow-ups[1][5].

Patient Counseling

Patients using DIPROLENE need to be informed about the potential side effects, such as skin atrophy, stinging, and systemic effects like Cushing's syndrome. They must also be advised on the proper use and duration of treatment to minimize risks[5].

Key Takeaways

• Growing Market: The topical drug delivery market, including DIPROLENE, is expected to grow significantly due to increasing skin disease incidence and a preference for non-invasive treatments.
• Competitive Landscape: The market is competitive with several major pharmaceutical companies involved.
• Regulatory Considerations: Strict regulatory guidelines are in place to ensure safety and efficacy.
• Financial Implications: The cost of DIPROLENE can be significant, but generic versions offer cost savings.
• Patient Safety: Careful monitoring is necessary to avoid systemic side effects, especially in pediatric patients.

Frequently Asked Questions (FAQs)

Q: What is DIPROLENE used for? A: DIPROLENE is used to treat skin conditions characterized by inflammation and itching, such as eczema, psoriasis, and atopic dermatitis.

Q: What are the potential side effects of DIPROLENE? A: Potential side effects include skin atrophy, stinging, and systemic effects like HPA axis suppression, Cushing's syndrome, and hyperglycemia.

Q: Can DIPROLENE be used in children? A: DIPROLENE should not be used in children under the age of 13 due to the high risk of HPA axis suppression and adrenal insufficiency.

Q: How long can DIPROLENE be used? A: DIPROLENE should only be used for the minimum time necessary and no more than 2 consecutive weeks, with a total dosage not exceeding 50 g per week.

Q: Is DIPROLENE available as a generic? A: Yes, DIPROLENE cream is available as a generic under the name augmented betamethasone propionate cream.

Cited Sources

1. RxList: Diprolene AF (Betamethasone): Side Effects, Uses, Dosage...
2. CT.gov: Prescription Drug Reimportation in Connecticut
3. Globenewswire: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 Globally at 6.3% CAGR
4. Drugs.com: Diprolene: 7 things you should know
5. FDA: DIPROLENE AF Cream - accessdata.fda.gov