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:	5,211
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
Germany	3478899
Hong Kong	42292	IMPROVED BETAMETHASONE DIPROPIONATE CREAM
Ireland	58042	Improved betamethasone dipropionate cream
Australia	565947
Israel	73626	BETAMETHASONE DIPROPIONATE CREAM
Denmark	582284

DIPROLENE AF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DIPROLENE AF

Introduction

DIPROLENE AF, a topical corticosteroid cream, is a significant player in the pharmaceutical market, particularly in the treatment of dermatological conditions such as psoriasis and atopic dermatitis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The global topical drug delivery market, which includes DIPROLENE AF, is projected to grow at a CAGR of 6.3% from 2024 to 2031, reaching a value of USD 177.97 billion by 2031 from USD 109.16 billion in 2024[3].

Product Profile

DIPROLENE AF Cream 0.05% contains betamethasone dipropionate, a high-potency corticosteroid. It is indicated for the treatment of corticosteroid-responsive dermatoses, including chronic plaque psoriasis and atopic dermatitis. The cream has shown efficacy in relieving the signs and symptoms of these conditions through clinical trials[4].

Market Drivers

Several factors drive the market for DIPROLENE AF:

Increasing Prevalence of Dermatological Conditions

The rising incidence of skin diseases such as psoriasis and atopic dermatitis is a significant driver. These conditions are becoming more prevalent, leading to an increased demand for effective treatments like DIPROLENE AF.

Technological Innovations

Advancements in topical drug delivery systems are enhancing the efficacy and safety of treatments. Innovations in formulation and delivery methods are making topical corticosteroids more appealing to both patients and healthcare providers[3].

Preference for Non-Invasive Treatments

There is a growing preference for non-invasive treatment methods, which topical creams like DIPROLENE AF cater to. Patients often prefer topical treatments over systemic medications due to fewer side effects and easier administration.

Market Restraints

Despite the drivers, there are several restraints that could impact the market for DIPROLENE AF:

Side Effects and Safety Concerns

Topical corticosteroids, including DIPROLENE AF, can cause side effects such as reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use or large treatment surface areas. These safety concerns can limit the use of the drug[4].

Alternative Treatments

The presence of alternative drugs and treatments can hinder the growth of DIPROLENE AF. For instance, other formulations like betamethasone acetate and newer treatments in the pipeline can compete with DIPROLENE AF[1].

Financial Trajectory

The financial performance of DIPROLENE AF is closely tied to the broader topical drug delivery market and the specific segment of corticosteroid creams.

Revenue Projections

While specific revenue figures for DIPROLENE AF are not readily available, the overall market for topical drug delivery is expected to grow significantly. Companies involved in the production and distribution of DIPROLENE AF, such as Merck & Co., Inc., are likely to benefit from this growth trend[1].

Key Players and Strategies

Companies like Merck & Co., Inc. and other key players in the market are focusing on inorganic strategies such as product launches and distribution network expansions. For example, Scilex Holding Company, a subsidiary of Sorrento Therapeutics, Inc., expanded its direct distribution network to national and regional wholesalers and pharmacies, which can positively impact the sales of DIPROLENE AF and similar products[1].

Geographical Performance

The market for DIPROLENE AF is influenced by geographical factors, particularly the demographics and healthcare needs of different regions.

Asia Pacific Region

The Asia Pacific region, with its large and aging population, presents a significant market opportunity. The increasing number of geriatric individuals in this region, who are more prone to skin conditions, drives the demand for topical corticosteroids like DIPROLENE AF[1].

Competitive Landscape

The competitive landscape for DIPROLENE AF includes other topical corticosteroids and alternative treatments.

Alternative Formulations

Betamethasone acetate and other corticosteroid formulations are alternatives that compete with DIPROLENE AF. Companies like Lupin have launched alternative products, such as betamethasone dipropionate ointment, which can compete directly with DIPROLENE AF[1].

Clinical and Regulatory Aspects

The efficacy and safety of DIPROLENE AF have been established through clinical trials.

Clinical Trials

DIPROLENE AF Cream has been evaluated in randomized and active-controlled trials for the treatment of chronic plaque psoriasis. These trials have demonstrated its effectiveness in relieving the signs and symptoms of the condition[4].

Regulatory Compliance

The drug must comply with regulatory requirements, including those related to safety, efficacy, and labeling. Adherence to these regulations is crucial for maintaining market presence and avoiding potential recalls or legal issues[4].

Key Takeaways

• Growing Market: The topical drug delivery market, including DIPROLENE AF, is expected to grow significantly due to increasing demand for localized treatment options.
• Technological Innovations: Advancements in formulation and delivery methods are enhancing the market for topical corticosteroids.
• Safety Concerns: Side effects such as HPA axis suppression are significant restraints that need careful management.
• Geographical Opportunities: The Asia Pacific region offers substantial market potential due to its large and aging population.
• Competitive Landscape: The market is competitive, with alternative formulations and treatments available.

Frequently Asked Questions (FAQs)

Q: What is DIPROLENE AF used for? A: DIPROLENE AF is used for the treatment of corticosteroid-responsive dermatoses, including chronic plaque psoriasis and atopic dermatitis.

Q: What are the potential side effects of DIPROLENE AF? A: Potential side effects include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use or large treatment surface areas.

Q: How does the market for DIPROLENE AF grow? A: The market for DIPROLENE AF grows due to the increasing prevalence of dermatological conditions, technological innovations, and a preference for non-invasive treatments.

Q: Who are the key players in the market for DIPROLENE AF? A: Key players include Merck & Co., Inc., and other pharmaceutical companies involved in the production and distribution of topical corticosteroids.

Q: What is the projected growth rate of the topical drug delivery market? A: The topical drug delivery market is projected to grow at a CAGR of 6.3% from 2024 to 2031.

Cited Sources

1. Coherent Market Insights: Betamethasone Acetate Market Size, Trends and Forecast to 2030.
2. Annual Reports: Perrigo 2020 Annual Report.
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. FDA: DIPROLENE AF Cream - accessdata.fda.gov.