Halobetasol propionate - Generic Drug Details

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

Halobetasol propionate is the generic ingredient in five branded drugs marketed by Padagis Israel, Mayne Pharma, Cosette, Fougera Pharms, Taro, Sun Pharm Inds Inc, Bausch, Lacer Pharma, Encube, and Quagen, and is included in nineteen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate has seventy-five patent family members in twenty-seven countries.

There are nine drug master file entries for halobetasol propionate. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for halobetasol propionate

International Patents:	75
US Patents:	13
Tradenames:	5
Applicants:	10
NDAs:	19
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	21
Patent Applications:	6,957
Drug Prices:	Drug price trends for halobetasol propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for halobetasol propionate
What excipients (inactive ingredients) are in halobetasol propionate?	halobetasol propionate excipients list
DailyMed Link:	halobetasol propionate at DailyMed

See drug prices for halobetasol propionate

Recent Clinical Trials for halobetasol propionate

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

Sponsor	Phase
Dermatology Consulting Services, PLLC	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 3
Citius Pharmaceuticals, Inc.	Phase 2

See all halobetasol propionate clinical trials

Generic filers with tentative approvals for HALOBETASOL PROPIONATE

Applicant	Application No.	Strength	Dosage Form
		UNKNOWN	UNKNOWN
		0.01%;0.045%	LOTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for halobetasol propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXETTE	Topical Foam	halobetasol propionate	0.05%	210566	1	2021-01-28
BRYHALI	Lotion	halobetasol propionate	0.01%	209355	1	2019-05-15
ULTRAVATE	Lotion	halobetasol propionate	0.05%	208183	1	2018-01-24

US Patents and Regulatory Information for halobetasol propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	11,839,656
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	10,857,159*PED				Y
Encube	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	209978-001	Mar 20, 2018		DISCN	No	No
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	8,809,307		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,986,527
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	8,809,307		Y
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990		DISCN	Yes	No

Expired US Patents for halobetasol propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990	4,619,921
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018	6,517,847
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990	4,619,921

International Patents for halobetasol propionate

Country	Patent Number	Title	Estimated Expiration
Philippines	12018501278	HALOBETASOL FOAM COMPOSITION AND METHOD OF USE THEREOF
South Korea	20180098300	할로베타솔 발포체 조성물 및 이의 사용 방법
Eurasian Patent Organization	201891352	ВСПЕНИВАЮЩИЕСЯ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД, И СПОСОБ ИХ ПРОИЗВОДСТВА
European Patent Office	2643002	FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
World Intellectual Property Organization (WIPO)	2012087443
Brazil	112013012476	formulações farmacêuticas contendo corticosteróides para administração tópica
South Korea	20150069005	국소 스테로이드 조성물 및 방법 (TOPICAL STEROID COMPOSITION AND METHOD)

Market Dynamics and Financial Trajectory of Halobetasol Propionate

Market Overview

Halobetasol propionate, a potent topical corticosteroid, is used primarily for the treatment of plaque psoriasis and other skin conditions. The market for this drug is experiencing significant growth, driven by increasing demand for effective treatments for dermatological conditions.

Market Size and Growth

The global halobetasol propionate market was valued at US$ 39 million in 2023 and is projected to reach US$ 54 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.9% during the forecast period of 2024-2030[1][4].

Segmentation

The market is segmented based on type and application. The types include 15g, 30g, and other formulations, while the applications are categorized into hospital, clinic, and other settings[1][4].

Geographical Distribution

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region is experiencing varying growth rates, with Asia-Pacific showing significant potential due to a large patient population and increasing healthcare expenditure[4].

Key Players

The market is dominated by several key players, including ULTRAVATE, LEXETTE, Glenmark Pharma, Sun Pharma, BRYHALI, PERRIGO, Duobrii, STERLING, Midas Pharma, Pfizer, Taro Pharmaceuticals, Glenwood Pharmaceuticals, and Fougera Pharmaceuticals. These companies are investing heavily in research and development, marketing, and distribution to capture a larger market share[1][4].

Product Launches and Innovations

Recent product launches have contributed significantly to the market's growth. For example, Mayne Pharma's launch of LEXETTE™ (halobetasol propionate) Foam 0.05% in the United States in 2019 marked a significant milestone. LEXETTE received FDA approval with three years of marketing exclusivity, positioning it strongly in the US$600 million potent topical corticosteroid market[2].

Market Drivers

Several factors are driving the growth of the halobetasol propionate market:

• Increasing Prevalence of Dermatological Conditions: Plaque psoriasis affects approximately 7.5 million Americans, and potent topical corticosteroids are prescribed to about 80% of these patients[2].
• Advancements in Formulations: New formulations such as foams and lotions are enhancing patient compliance and efficacy, contributing to market growth.
• Growing Healthcare Expenditure: Increasing healthcare spending in various regions is enabling more patients to access these treatments.

Market Restraints

Despite the growth, there are several restraints to consider:

• Side Effects and Safety Concerns: Topical corticosteroids, including halobetasol propionate, can have adverse effects such as skin thinning, adrenal suppression, and systemic exposure, which may limit their use[5].
• Regulatory Hurdles: Strict regulatory approvals and the need for extensive clinical trials can slow down the introduction of new products.

Competitive Landscape

The competitive landscape is intense, with multiple players vying for market share. Companies are focusing on innovative formulations, direct-to-consumer advertising, and expanding their sales force capabilities to stay competitive. For instance, Bausch Health is investing in direct-to-consumer advertising and new sales force capabilities, leveraging artificial intelligence and machine learning to enhance their market presence[3].

Financial Performance

The financial performance of companies involved in the halobetasol propionate market is robust. For example, the potent topical corticosteroid market, which includes halobetasol propionate, generates significant revenue, with 8 million prescriptions written annually in the United States alone[2].

Regional Growth

North America is a major market for halobetasol propionate, driven by the high prevalence of psoriasis and other skin conditions. However, the Asia-Pacific region is expected to show substantial growth due to increasing healthcare awareness and expenditure[4].

Future Outlook

The future outlook for the halobetasol propionate market is positive, with sustained growth expected through 2030. The market will continue to be driven by the increasing demand for effective treatments for dermatological conditions, advancements in formulations, and expanding healthcare access in various regions.

Key Takeaways

• The global halobetasol propionate market is projected to grow from US$ 39 million in 2023 to US$ 54 million by 2030 at a CAGR of 4.9%.
• The market is segmented by type (15g, 30g, other) and application (hospital, clinic, other).
• Key players include ULTRAVATE, LEXETTE, Glenmark Pharma, and others.
• New product launches and innovations, such as LEXETTE Foam, are driving market growth.
• Increasing prevalence of dermatological conditions and advancements in formulations are major market drivers.
• Regulatory hurdles and side effects are significant restraints.

Frequently Asked Questions (FAQs)

1. What is the current market size of halobetasol propionate?

The global halobetasol propionate market was valued at US$ 39 million in 2023[1].

2. What is the expected growth rate of the halobetasol propionate market?

The market is expected to grow at a CAGR of 4.9% from 2024 to 2030[1].

3. Who are the key players in the halobetasol propionate market?

Key players include ULTRAVATE, LEXETTE, Glenmark Pharma, Sun Pharma, BRYHALI, PERRIGO, Duobrii, STERLING, Midas Pharma, Pfizer, Taro Pharmaceuticals, Glenwood Pharmaceuticals, and Fougera Pharmaceuticals[1][4].

4. What are the primary applications of halobetasol propionate?

The primary applications are in the treatment of plaque psoriasis and other skin conditions, with usage in hospitals, clinics, and other settings[1][4].

5. What are the major drivers of the halobetasol propionate market?

Major drivers include the increasing prevalence of dermatological conditions, advancements in formulations, and growing healthcare expenditure[2][4].

Last updated: 2024-12-16