HALCINONIDE - Generic Drug Details

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

Halcinonide is the generic ingredient in three branded drugs marketed by Chartwell Rx, Mylan, Sun Pharm Inds Inc, Westwood Squibb, Bristol Myers Squibb, and Encube, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for halcinonide. Four suppliers are listed for this compound.

Summary for HALCINONIDE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	6,763
Drug Prices:	Drug price trends for HALCINONIDE
What excipients (inactive ingredients) are in HALCINONIDE?	HALCINONIDE excipients list
DailyMed Link:	HALCINONIDE at DailyMed

See drug prices for HALCINONIDE

Pharmacology for HALCINONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for HALCINONIDE

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for HALCINONIDE

D07AD	Corticosteroids, very potent (group IV)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for HALCINONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Westwood Squibb	HALOG	halcinonide	CREAM;TOPICAL	017818-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Inds Inc	HALOG-E	halcinonide	CREAM;TOPICAL	018234-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	HALCINONIDE	halcinonide	CREAM;TOPICAL	214723-001	Sep 8, 2021	AB	RX	No	No

HALCINONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Halcinonide

Introduction to Halcinonide

Halcinonide is a topical corticosteroid used for the management and symptomatic relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available in various formulations, including creams and ointments, and is marketed under the brand name Halog® among others[4].

Market Size and Growth

The global topical corticosteroids market, which includes halcinonide, has been experiencing significant growth. In 2023, the market was valued at USD 4,270.71 million and is projected to grow to USD 6,102.07 million by 2030, with a Compounded Annual Growth Rate (CAGR) of 5.2%[3].

Drivers of Market Growth

Several factors are driving the growth of the topical corticosteroids market, including:

Increasing Prevalence of Dermatological Conditions

The rising prevalence of skin disorders such as eczema, psoriasis, and dermatitis is a major driver. These conditions require effective anti-inflammatory treatments, making topical corticosteroids like halcinonide essential[3].

Growing Geriatric Population

The increasing geriatric population, which is more prone to skin-related issues, has further fueled the demand for topical corticosteroids[3].

Healthcare Awareness and Technological Advancements

Growing healthcare awareness and the emphasis on maintaining healthy skin, along with technological advancements in drug formulations, have led to the development of more effective and safer topical corticosteroids. This enhances therapeutic outcomes and patient compliance[3].

Market Segmentation

The global topical corticosteroids market is segmented by type of formulation, type of potency class, type of treatment, end user, and geography.

Formulation Types

Halcinonide is available in various formulations such as creams and ointments, catering to different patient needs and preferences[4].

Potency Classes

Halcinonide falls under the very potent (Group IV) corticosteroids category, which is crucial for managing severe dermatological conditions[4].

Geographical Distribution

The market is expanding across different regions, supported by robust marketing campaigns and improved healthcare infrastructure. Emerging markets in Asia and Latin America offer significant growth potential due to increasing disposable incomes and growing awareness about dermatological treatments[3].

Recent Developments and Regulatory Landscape

Competitive Generic Therapy (CGT) Designation

Encube Ethicals Private Limited was granted a CGT designation for Halcinonide Topical Solution USP, 0.1%, making it the first approved applicant. This designation comes with 180 days of CGT exclusivity, which begins from the date of the first commercial marketing of the product[1].

Approval and Bioequivalence

The FDA has determined that Halcinonide Topical Solution USP, 0.1% is bioequivalent and therapeutically equivalent to the reference listed drug, Halog Topical Solution, 0.1% by Sun Pharmaceutical Industries, Inc.[1].

Challenges and Restraints

Side Effects and Safety Concerns

Prolonged use of corticosteroids like halcinonide can lead to side effects such as skin thinning and hormonal imbalances. These concerns can impact market growth[3].

Regulatory Policies and High Treatment Costs

Strict regulatory policies and high treatment costs are additional barriers to market expansion. However, these challenges are being addressed through ongoing research and development aimed at introducing safer and more affordable products[3].

Financial Trajectory

The financial trajectory for halcinonide and the broader topical corticosteroids market is positive, driven by increasing demand and expanding market reach.

Revenue Projections

The market is expected to grow from USD 4,270.71 million in 2023 to USD 6,102.07 million by 2030, indicating a robust financial outlook[3].

Investments in Research and Development

Pharmaceutical companies are investing significantly in research and development to introduce innovative products with minimal side effects. This investment is expected to attract a larger customer base and drive revenue growth[3].

Key Takeaways

• The global topical corticosteroids market, including halcinonide, is growing significantly due to the increasing prevalence of dermatological conditions and a growing geriatric population.
• Technological advancements and healthcare awareness are driving market expansion.
• The market faces challenges such as side effects and regulatory policies, but ongoing research and development are addressing these issues.
• The financial trajectory is positive, with projected revenue growth from USD 4,270.71 million in 2023 to USD 6,102.07 million by 2030.

FAQs

What is Halcinonide used for?

Halcinonide is used for the management and symptomatic relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses[4].

What are the common formulations of Halcinonide?

Halcinonide is available in various formulations, including creams and ointments[4].

What is the Competitive Generic Therapy (CGT) designation for Halcinonide?

Encube Ethicals Private Limited was granted a CGT designation for Halcinonide Topical Solution USP, 0.1%, which includes 180 days of CGT exclusivity[1].

What are the potential side effects of using Halcinonide?

Prolonged use of halcinonide can lead to side effects such as skin thinning and hormonal imbalances[3].

What is the projected market size for topical corticosteroids by 2030?

The global topical corticosteroids market is expected to grow to USD 6,102.07 million by 2030[3].

Cited Sources

1. U.S. Food & Drug Administration, "Halcinonide Topical Solution - accessdata.fda.gov"
2. Oregon Drug Use Review / Pharmacy & Therapeutics Committee, "2020_12_03_PnT_Complete.pdf"
3. Reanin, "Topical Corticosteroids Market | Growth | Share | Size | Trends and Forecast"
4. DrugBank, "Halcinonide: Uses, Interactions, Mechanism of Action - DrugBank"