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Last Updated: December 22, 2024

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE - Generic Drug Details


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What are the generic drug sources for betamethasone dipropionate; clotrimazole and what is the scope of patent protection?

Betamethasone dipropionate; clotrimazole is the generic ingredient in two branded drugs marketed by Actavis Mid Atlantic, Fougera Pharms, Glenmark Speclt, Taro, Organon, and Merck Sharp Dohme, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Recent Clinical Trials for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

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

SponsorPhase
Ache Laboratorios Farmaceuticos S.A.Phase 3

See all BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
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
D01AC Imidazole and triazole derivatives
D01A ANTIFUNGALS FOR TOPICAL USE
D01 ANTIFUNGALS FOR DERMATOLOGICAL USE
D Dermatologicals
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
G01AF Imidazole derivatives
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
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

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 075673-001 May 29, 2001 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Organon LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Mid Atlantic CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 076002-001 Aug 2, 2002 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076493-001 Jul 28, 2004 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Speclt CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 202894-001 Oct 30, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076516-001 Jun 16, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 3,660,577 ⤷  Subscribe
Organon LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 4,298,604 ⤷  Subscribe
Organon LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 3,839,573 ⤷  Subscribe
Organon LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 3,705,172 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betamethasone Dipropionate; Clotrimazole

Market Overview

The combination drug Betamethasone Dipropionate and Clotrimazole, commonly known by the brand name Lotrisone, is a topical antifungal and anti-inflammatory medication. This market is driven by several key factors that influence its growth and financial trajectory.

Market Size and Growth

The market for Clotrimazole and Betamethasone Dipropionate was valued at USD 142.3 million in 2023 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].

Drivers of Market Growth

Increasing Prevalence of Fungal Infections

The rising incidence of fungal skin infections, particularly in tropical and humid regions, is a significant driver of the market. Conditions such as athlete's foot and ringworm contribute to the heightened demand for effective topical treatments like Clotrimazole and Betamethasone Dipropionate[1].

Growing Awareness and Focus on Skin Care

The growing awareness among healthcare professionals and patients about the efficacy of combination therapies in treating multiple symptoms simultaneously is another key driver. Additionally, the increasing focus on personal healthcare and skin hygiene further boosts the market for these medications[1].

Advancements in Pharmaceutical Manufacturing

Innovations in pharmaceutical manufacturing, such as improved formulations that allow for longer shelf life, enhanced efficacy, and better patient compliance, are crucial factors expected to boost market growth. The expansion of online pharmaceutical platforms also facilitates easier access to these medications, especially in remote areas[1].

Market Challenges

High Development and Commercialization Costs

One of the significant challenges facing the market is the high cost of drug development and commercialization. Pharmaceutical companies must invest substantial resources in clinical trials, regulatory approvals, and marketing efforts, which can be prohibitive for smaller companies[1].

Drug Resistance

The growing issue of drug resistance, particularly to antifungal medications like Clotrimazole, poses a challenge. As fungi become more resistant to commonly used drugs, the efficacy of existing treatments may decline, necessitating the development of new and more potent medications[1].

Adverse Effects and Cost-Effectiveness

The combination of Clotrimazole and Betamethasone Dipropionate has been criticized for its potential to induce steroid-related side effects and for being less cost-effective compared to antifungal monotherapy. This includes concerns about treatment failure, striae distensae, hirsutism, and growth retardation, especially in children[2].

Investment Opportunities

Research and Development

Investing in research and development (R&D) is a key area of opportunity. Pharmaceutical companies are focusing on developing new formulations and delivery mechanisms for combination therapies, such as slow-release formulations and advanced topical applications. These innovations can provide patients with longer-lasting relief and enhance therapeutic efficacy and patient compliance[1].

Regulatory Compliance and Strategic Partnerships

Companies that can navigate the regulatory landscape effectively and establish strong partnerships with healthcare providers and regulatory bodies are well-positioned for long-term success. Collaborations with research institutions and contract research organizations (CROs) can accelerate the development and approval of new products in this market[1].

Regional Analysis

US Market

The US market for Clotrimazole and Betamethasone Dipropionate is expected to witness steady growth, driven by the rising prevalence of fungal skin infections and the increasing demand for effective combination treatments. The growing awareness of topical antifungal therapies and advancements in dermatological treatments also contribute to this growth[1].

Global Perspective

While the US market is significant, the global market for Betamethasone Dipropionate, in various formulations, also shows promising growth. For instance, the global Betamethasone Acetate market, which includes different applications such as dermatological diseases, is expected to exhibit a CAGR of 4.8% between 2022 and 2030, with North America dominating the market share[3].

Prescribing Trends and Usage

Common Prescriptions

Clotrimazole-Betamethasone Dipropionate is the most commonly prescribed topical antifungal-corticosteroid medication in the US, particularly for treating inflammatory dermatophytosis (ringworm). However, it is not recommended for use in persons younger than 17 years or intravaginally due to the high-potency corticosteroid component[4].

Non-Fungal Skin Conditions

A significant portion of prescriptions for Clotrimazole-Betamethasone Dipropionate are for non-fungal skin conditions such as noninfectious dermatitis, eczema, and nonspecific rashes. This indicates a need for physician education to ensure appropriate prescribing practices[4].

Regulatory Considerations

The FDA has specific guidelines for the development and approval of generic versions of Betamethasone Dipropionate and Clotrimazole creams. These guidelines include recommendations for clinical endpoint bioequivalence studies to ensure the efficacy and safety of generic products[5].

Financial Trajectory

The financial trajectory of the Clotrimazole and Betamethasone Dipropionate market is positive, with projected growth driven by increasing demand and advancements in pharmaceutical manufacturing. Here are some key financial highlights:

  • Market Size: Projected to grow from USD 142.3 million in 2023 to USD 257.76 million by 2032.
  • CAGR: Expected to be 6.2% during the forecast period of 2024-2032.
  • Investment Opportunities: Significant opportunities in R&D, regulatory compliance, and strategic partnerships.

Key Takeaways

  • The Clotrimazole and Betamethasone Dipropionate market is driven by the rising prevalence of fungal skin infections and the increasing demand for effective combination treatments.
  • Advancements in pharmaceutical manufacturing and the expansion of online pharmaceutical platforms are key growth factors.
  • The market faces challenges such as high development costs, drug resistance, and adverse effects.
  • Investment opportunities exist in R&D, regulatory compliance, and strategic partnerships.
  • The US market is significant, but global markets also show promising growth.

FAQs

What is the projected market size for Clotrimazole and Betamethasone Dipropionate by 2032?

The market is projected to reach USD 257.76 million by 2032, growing at a CAGR of 6.2% during the forecast period of 2024-2032[1].

What are the main drivers of the Clotrimazole and Betamethasone Dipropionate market?

The main drivers include the increasing prevalence of fungal skin infections, growing awareness of topical antifungal therapies, and advancements in pharmaceutical manufacturing[1].

What are the challenges facing the Clotrimazole and Betamethasone Dipropionate market?

Challenges include high development and commercialization costs, the growing issue of drug resistance, and concerns about adverse effects and cost-effectiveness[1][2].

What investment opportunities exist in the Clotrimazole and Betamethasone Dipropionate market?

Investment opportunities exist in research and development (R&D), regulatory compliance, and strategic partnerships with healthcare providers and regulatory bodies[1].

Is Clotrimazole-Betamethasone Dipropionate commonly prescribed for non-fungal skin conditions?

Yes, a significant portion of prescriptions for Clotrimazole-Betamethasone Dipropionate are for non-fungal skin conditions, indicating a need for physician education to ensure appropriate prescribing practices[4].

What are the regulatory considerations for Clotrimazole and Betamethasone Dipropionate?

The FDA has specific guidelines for the development and approval of generic versions, including recommendations for clinical endpoint bioequivalence studies to ensure efficacy and safety[5].

Sources

  1. Global Growth Insights: Clotrimazole and Betamethasone Dipropionate Market Report.
  2. PubMed: Clotrimazole/betamethasone diproprionate: a review of costs and complications in the treatment of common cutaneous fungal infections.
  3. Coherent Market Insights: Betamethasone Acetate Market Size, Trends and Forecast to 2030.
  4. JAMA Network Open: Clotrimazole-Betamethasone Prescribing for Nonfungal Skin Conditions.
  5. FDA: Draft Guidance on Betamethasone Dipropionate; Clotrimazole Cream.

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