BETAMETHASONE DIPROPIONATE - Generic Drug Details

What are the generic sources for betamethasone dipropionate and what is the scope of freedom to operate?

Betamethasone dipropionate is the generic ingredient in thirteen branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, Schering, Organon, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, and Merck Sharp Dohme, and is included in seventy-seven NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has seven patent family members in five countries.

There are thirteen drug master file entries for betamethasone dipropionate. Twenty-five suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE

International Patents:	7
US Patents:	17
Tradenames:	13
Applicants:	31
NDAs:	77
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	66
Patent Applications:	6,862
Drug Prices:	Drug price trends for BETAMETHASONE DIPROPIONATE
Drug Sales Revenues:	Drug sales revenues for BETAMETHASONE DIPROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE
What excipients (inactive ingredients) are in BETAMETHASONE DIPROPIONATE?	BETAMETHASONE DIPROPIONATE excipients list
DailyMed Link:	BETAMETHASONE DIPROPIONATE at DailyMed

See drug prices for BETAMETHASONE DIPROPIONATE

See drug sales revenues for BETAMETHASONE DIPROPIONATE

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE

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

Sponsor	Phase
Dermavant Sciences, Inc.	Phase 2/Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Oticara Australia PTY LTD	Phase 2

See all BETAMETHASONE DIPROPIONATE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SERNIVO	Topical Spray	betamethasone dipropionate	0.05%	208079	1	2018-02-15

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM;TOPICAL	071143-001	Jun 17, 1987		DISCN	No	No
Taro	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	LOTION;TOPICAL	076493-001	Jul 28, 2004	AB	RX	No	Yes
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,617,698		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,877,974		Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,660,908		Y
Pharmaderm	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM;TOPICAL	019136-001	Jun 26, 1984		DISCN	No	No

Expired US Patents for BETAMETHASONE DIPROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988	4,775,529
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986	4,482,539
Organon	DIPROLENE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	018741-001	Jul 27, 1983	4,070,462
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991	4,489,070
Organon	DIPROLENE AF	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019555-001	Apr 27, 1987	4,489,071
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986	4,489,070

International Patents for BETAMETHASONE DIPROPIONATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3141246
Denmark	2473161
Japan	2013503203
World Intellectual Property Organization (WIPO)	2011026076
Spain	2637447
Japan	5833007

BETAMETHASONE DIPROPIONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betamethasone Dipropionate

Introduction to Betamethasone Dipropionate

Betamethasone dipropionate is a potent topical corticosteroid widely used in the treatment of various skin conditions, including psoriasis, eczema, and fungal infections. When combined with other active ingredients like clotrimazole or calcipotriene, it forms effective combination therapies that target multiple symptoms simultaneously.

Market Size and Growth Projections

The market for betamethasone dipropionate, particularly in combination with clotrimazole, is experiencing significant growth. As of 2023, the Clotrimazole and Betamethasone Dipropionate market was valued at USD 142.3 million and is projected to reach USD 151.13 million in 2024. By 2032, the market is expected to grow to USD 257.76 million, with a compound annual growth rate (CAGR) of 6.2% during the forecast period of 2024-2032[1].

Key Drivers of Market Growth

Several factors are driving the growth of the betamethasone dipropionate market:

Increasing Prevalence of Skin Conditions

The rising prevalence of fungal skin infections and other dermatological conditions is a significant driver. Regions with tropical and humid climates are particularly affected, leading to a higher demand for effective treatments like betamethasone dipropionate[1].

Advancements in Dermatological Treatments

Advancements in pharmaceutical manufacturing and distribution channels are enhancing the quality, accessibility, and affordability of betamethasone dipropionate. Innovations such as extended-release formulations and better delivery systems are improving patient compliance and reducing side effects[1].

Growing Awareness of Topical Therapies

Increased awareness of the benefits of topical antifungal and anti-inflammatory medications is driving market growth. Patients are seeking timely medical interventions for skin-related issues, further stimulating demand[1].

Expansion of Healthcare Services

The expansion of healthcare services in emerging markets, such as Asia-Pacific, Latin America, and Africa, is creating new opportunities for the betamethasone dipropionate market. These regions have a high prevalence of fungal infections and are witnessing rapid improvements in healthcare infrastructure[1].

Market Trends

Preference for Combination Therapies

Healthcare providers are increasingly recommending combination drugs like clotrimazole and betamethasone dipropionate, which target multiple symptoms simultaneously. This trend is particularly significant in dermatology, where combination treatments offer improved patient outcomes and convenience[1].

E-commerce Growth

The rise of online pharmacies is facilitating easier access to medications, especially in remote areas where physical healthcare infrastructure is limited. This trend is expected to drive the demand for betamethasone dipropionate products[1].

Telemedicine Integration

The COVID-19 pandemic has accelerated the adoption of telemedicine, making it easier for patients to receive prescriptions remotely. This has expanded the market reach of pharmaceutical companies offering betamethasone dipropionate products[1].

Financial Impact and Cost-Effectiveness

Budget Impact Models

Studies have shown that the introduction of combination therapies like calcipotriene and betamethasone dipropionate can significantly reduce healthcare costs. For instance, a budget impact model for treating moderate-to-severe psoriasis estimated that the annual cost of treatment could decrease by $36,112,572 with the introduction of such combination therapies[2].

Cost-Effectiveness

Betamethasone dipropionate, when used in combination with other medications, often proves more cost-effective than biologic treatments. For example, calcipotriene and betamethasone dipropionate foam had the lowest per-patient cost ($9,913) to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared to other biologic treatments[2].

Regional Market Dynamics

North America

In North America, the betamethasone dipropionate market is driven by the increasing application of the medication for various ailments, including rheumatic disorders and autoimmune diseases like systemic lupus erythematosus[4].

Asia-Pacific

The Asia-Pacific region is expected to have the fastest CAGR due to factors such as an increase in cases of asthma and other chronic ailments, which are driving the extensive application of betamethasone dipropionate[4].

Market Opportunities

Emerging Markets

The expansion of healthcare services in emerging markets presents a lucrative opportunity for growth. These regions have a high prevalence of fungal infections and are witnessing rapid improvements in healthcare infrastructure[1].

Advanced Drug Formulations

Pharmaceutical companies are investing in research and development to create more effective and safer formulations of betamethasone dipropionate. Innovations such as extended-release formulations and better delivery systems are expected to drive market expansion[1].

E-commerce and Telemedicine

The rise of e-commerce in the pharmaceutical industry and the integration of telemedicine are offering new avenues for market growth by facilitating easier access to medications, especially in remote areas[1].

Challenges and Regulatory Considerations

Regulatory Frameworks

The market is subject to various regulatory considerations, including the need for compliance with safety and efficacy standards. For instance, the FDA has conducted extensive reviews and evaluations of combination products like calcipotriene and betamethasone dipropionate to ensure their safety and efficacy[5].

Side Effects and Safety Concerns

While betamethasone dipropionate is generally safe, there are potential side effects and safety concerns, such as local and systemic adverse reactions, including erythema, folliculitis, and decreased blood cortisol levels. These need to be carefully managed and monitored[5].

Key Takeaways

• The betamethasone dipropionate market is growing significantly, driven by the increasing prevalence of skin conditions and advancements in dermatological treatments.
• Combination therapies, e-commerce growth, and telemedicine integration are key trends shaping the market.
• The market is expected to reach USD 257.76 million by 2032, with a CAGR of 6.2% during the forecast period.
• Emerging markets and advanced drug formulations present significant opportunities for growth.
• Regulatory compliance and managing side effects are crucial for market success.

FAQs

Q: What is the projected market size of the Clotrimazole and Betamethasone Dipropionate market by 2032? A: The Clotrimazole and Betamethasone Dipropionate market is projected to reach USD 257.76 million by 2032[1].

Q: What are the key drivers of the betamethasone dipropionate market? A: Key drivers include the increasing prevalence of skin conditions, advancements in dermatological treatments, growing awareness of topical therapies, and the expansion of healthcare services in emerging markets[1].

Q: How does the combination of calcipotriene and betamethasone dipropionate impact healthcare costs? A: The introduction of this combination therapy can significantly reduce healthcare costs, with an estimated annual cost reduction of $36,112,572 for treating moderate-to-severe psoriasis[2].

Q: What are the potential side effects of betamethasone dipropionate? A: Potential side effects include local and systemic adverse reactions such as erythema, folliculitis, and decreased blood cortisol levels[5].

Q: How is the rise of e-commerce affecting the betamethasone dipropionate market? A: The rise of e-commerce is facilitating easier access to medications, especially in remote areas, which is expected to drive the demand for betamethasone dipropionate products[1].

Cited Sources

1. Global Growth Insights - Clotrimazole and Betamethasone Dipropionate Market
2. PubMed - Budget impact model in moderate-to-severe psoriasis vulgaris
3. University of Maryland - Betamethasone dipropionate: Summary Report
4. IndustryARC - Betamethasone Ointment Market - Forecast(2024 - 2030)
5. FDA - Clinical Review and Evaluation - Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension