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

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

There are nine drug master file entries for halobetasol propionate. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for halobetasol propionate

International Patents:	77
US Patents:	13
Tradenames:	6
Applicants:	10
NDAs:	20
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	21
Patent Applications:	7,833
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

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
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	077123-001	Dec 16, 2004	AB	RX	No	No
Sun Pharma Canada	HALOBETASOL PROPIONATE	halobetasol propionate	OINTMENT;TOPICAL	076994-001	Dec 16, 2004		DISCN	No	No
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes			Y

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
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018

International Patents for halobetasol propionate

Country	Patent Number	Title	Estimated Expiration
Mexico	375152
South Korea	101967121
European Patent Office	2919753	PROCÉDÉ ET COMPOSITION DE STÉROÏDE TOPIQUE (TOPICAL STEROID COMPOSITION AND METHOD)

Market Dynamics and Financial Trajectory for HALOBETASOL PROPIONATE

Last updated: July 28, 2025

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Introduction

Halobetasol Propionate is a potent topical corticosteroid widely used for treating inflammatory skin conditions, including psoriasis, eczema, and dermatitis. The drug’s robust anti-inflammatory properties make it a mainstay in dermatology, but its market growth is influenced by multifaceted factors spanning regulatory landscapes, competitive dynamics, innovative developments, and regional demand variations.

This article evaluates the underlying market dynamics and forecasts the financial trajectory of Halobetasol Propionate, providing strategic insights essential for stakeholders and investors.

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Pharmacological Profile and Therapeutic Applications

Halobetasol Propionate offers high corticosteroid potency (Class I), primarily addressing severe inflammatory dermatoses. Its efficacy is balanced against the risk profile, as high potency corticosteroids can cause adverse effects like skin atrophy, prompting cautious prescription and usage guidelines.

The drug is predominantly formulated for topical application—creams, ointments, and gels—serving dermatological needs worldwide. Regulatory agencies like the FDA approve formulations with strict usage parameters, which impacts market penetration and growth potential.

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Market Landscape and Competitive Environment

Existing Pipeline and Market Share:
Currently, Halobetasol Propionate is marketed by major pharma players such as Teva Pharmaceuticals and Mylan, often under generic formulations. The dominance of generics has led to a commoditized price environment, reducing revenue margins for manufacturers compared to branded alternatives.

Competitive Dynamics:
The corticosteroid segment faces intense competition from alternative therapies, including non-steroidal agents (calcineurin inhibitors) and biologics for specific indications like psoriasis. The introduction of new formulations, such as foam or ultra-potent topical steroids with improved safety profiles, influences market share shifts and pricing strategies.

Regulation and Reimbursement:
Stringent regulatory oversight restricts overuse and long-term application—particularly relevant given the potency of Halobetasol Propionate. Insurance coverage and reimbursement policies vary across regions, impacting patient accessibility and market expansion.

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Regulatory and Safety Considerations

Regulatory Enforcements:
Global regulatory agencies enforce guidelines on potency limits, duration of use, and contraindications. These regulations influence the development and marketing of Halobetasol Propionate, often constraining its growth to specific clinical niches.

Safety Profile and Prescriber's Preference:
Potential adverse effects associated with high-potency steroids limit prolonged use, favoring newer, safer alternatives. Consequently, pharmaceutical companies invest in reformulation or combination therapies to mitigate safety concerns and extend market viability.

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Regional Market Dynamics

North America:
The U.S. remains the largest market, driven by high prevalence of dermatological disorders, robust healthcare infrastructure, and aggressive marketing by key players. However, strict prescribing guidelines and concerns over side effects impact long-term market growth.

Europe:
Market growth is tempered by stringent regulations and emphasis on safety. Europe's focus on dermatology treatment protocols favors innovative formulations that balance efficacy and safety.

Asia-Pacific:
This region exhibits significant growth potential due to rising dermatology disease prevalence, increasing disposable income, and expanding healthcare access. Local manufacturing and price sensitivity facilitate the penetration of generic formulations of Halobetasol Propionate.

Emerging Markets:
markets such as Latin America and parts of Africa show increased demand driven by expanding pharmaceutical infrastructure and rising awareness, though regulatory and logistical challenges persist.

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Innovations and R&D Trajectories

The pharmaceutical industry is shifting towards developing next-generation topical steroids with enhanced safety profiles. Innovations include:

• Combination therapies: Pairing Halobetasol Propionate with other agents (e.g., antihistamines) for improved efficacy.
• Alternative delivery mechanisms: Foam or patch formulations to optimize drug absorption and reduce side effects.
• Molecular modifications: Derivatives of Halobetasol Propionate with reduced potency but enhanced safety, catering to long-term management.

These advancements influence the future financial trajectory by potentially expanding indications and improving patient adherence.

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Financial Trajectory and Market Projections

Current Revenue and Market Share:
Most revenues are derived from generic formulations, with global sales estimated at hundreds of millions USD annually. As a mature product, growth primarily stems from market expansion and regional diversification.

Forecasted Growth:
The global topical corticosteroids market, estimated to reach USD 4 billion by 2027 (CAGR ~4-5%), influences the segment of high-potency corticosteroids like Halobetasol Propionate. Market growth hinges on increasing dermatological condition prevalence, regulatory approvals for new formulations, and shifts towards combination therapies.

Key Drivers:

• Rising incidence of chronic skin conditions.
• Increased awareness and diagnosis, especially in aging populations.
• Expansion into emerging markets.
• Innovations leading to better safety and efficacy profiles.

Key Challenges:

• Regulatory limitations due to safety concerns.
• Intense competition from generics and emerging therapies.
• Pricing pressures in commoditized markets.
• Prescriber caution regarding potent steroids.

Scenario Analysis:
In a favorable regulatory environment with increased regional penetration, Halobetasol Propionate could see annual growth rates of 3–4%. Conversely, safety concerns and regulatory restrictions might constrain long-term expansion, emphasizing the importance of innovation and targeted marketing.

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Strategic Outlook

Pharmaceutical companies investing in Halobetasol Propionate should prioritize:

• R&D to develop safer, more patient-friendly formulations.
• Geographical expansion into underserved markets with increasing dermatology burdens.
• Partnerships with healthcare providers to optimize prescribing practices.
• Brand differentiation through education and outcome-based evidence.

Balance between safety, efficacy, and regulatory compliance will shape the product's financial trajectory over the next decade.

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Key Takeaways

• Market maturity and commoditization of Halobetasol Propionate limit growth potential but open opportunities in emerging markets through price-sensitive innovation.
• Regulatory constraints stemming from safety concerns influence both formulation development and prescribing practices.
• Innovation-driven formulations and combination therapies are critical for extending market relevance.
• Regional disparities necessitate tailored market entry strategies, with Asia-Pacific and Latin America offering significant upside.
• Insurance and reimbursement policies will significantly influence access, prescribing, and ultimately, revenue streams.

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FAQs

1. What are the primary therapeutic applications of Halobetasol Propionate?
It is primarily used to treat severe inflammatory skin conditions like psoriasis, eczema, and dermatitis due to its potent anti-inflammatory effects.

2. How does regulation impact the market for Halobetasol Propionate?
Regulatory agencies enforce strict guidelines on potency, usage duration, and safety, affecting prescribing practices, formulation development, and market access.

3. Who are the key market players for Halobetasol Propionate?
Major players include Teva Pharmaceuticals, Mylan, and other generic manufacturers, mainly offering formulations across global markets.

4. What are the main challenges facing the growth of Halobetasol Propionate?
Safety concerns, regulatory restrictions, competition from alternative therapies, and pricing pressures hinder expansion.

5. What future innovations might influence the market trajectory?
Development of safer formulations, combination therapies, new delivery mechanisms (foam/patch), and molecular modifications are poised to reshape the landscape.

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References

1. [1] Market Watch. “Topical Corticosteroids Market Size & Share.” (2022).
2. [2] FDA. “Guidance for the Industry: Topical Corticosteroids.” (2021).
3. [3] Grand View Research. “Dermatology Drugs Market Analysis.” (2022).
4. [4] European Medicines Agency. “Regulatory Framework for Topical Corticosteroids.” (2022).
5. [5] Pharmaceutical Technology. “Innovations in Topical Corticosteroid Formulations.” (2023).