ULTRAVATE Drug Patent Profile

Which patents cover Ultravate, and what generic alternatives are available?

Ultravate is a drug marketed by Sun Pharm Inds Inc and Lacer Pharma and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in eighteen countries.

The generic ingredient in ULTRAVATE is halobetasol propionate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultravate

A generic version of ULTRAVATE was approved as halobetasol propionate by FOUGERA PHARMS on December 16^th, 2004.

Summary for ULTRAVATE

International Patents:	22
US Patents:	1
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	8
Patent Applications:	4,964
Drug Prices:	Drug price information for ULTRAVATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULTRAVATE
What excipients (inactive ingredients) are in ULTRAVATE?	ULTRAVATE excipients list
DailyMed Link:	ULTRAVATE at DailyMed

See drug prices for ULTRAVATE

Recent Clinical Trials for ULTRAVATE

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 2
Bausch Health Americas, Inc.	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 1

See all ULTRAVATE clinical trials

Paragraph IV (Patent) Challenges for ULTRAVATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTRAVATE	Lotion	halobetasol propionate	0.05%	208183	1	2018-01-24

US Patents and Regulatory Information for ULTRAVATE

ULTRAVATE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990		DISCN	Yes	No
Lacer Pharma	ULTRAVATE	halobetasol propionate	LOTION;TOPICAL	208183-001	Nov 6, 2015		DISCN	Yes	No	8,962,028		Y
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990		DISCN	Yes	No

Expired US Patents for ULTRAVATE

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
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990	4,619,921

International Patents for ULTRAVATE

See the table below for patents covering ULTRAVATE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	462763
South Korea	101832041
United Kingdom	1563638
Australia	2013331271	Topical steroid composition and method
Canada	1056371	STEROIDES POLYHALOGENES ET PROCEDE DE FABRICATION (POLYHALOGENO-STEROIDS AND PROCESSES FOR THEIR MANUFACTURE)
Belgium	859120
Austria	363204

Market Dynamics and Financial Trajectory of ULTRAVATE (Halobetasol Propionate)

Market Overview

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

Market Size and Growth

The global halobetasol propionate market, which includes ULTRAVATE, was valued at US$ 39 million in 2023. It 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].

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. ULTRAVATE is available in various formulations such as cream, lotion, and ointment, each with a strength of 0.05%[4].

Geographical Distribution

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. North America is a major market for ULTRAVATE, 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[1].

Key Players

ULTRAVATE is one of the key products in the halobetasol propionate market, which is dominated by several major pharmaceutical companies. These include Sun Pharma, Glenmark Pharma, Pfizer, Taro Pharmaceuticals, and others. These companies are investing heavily in research and development, marketing, and distribution to capture a larger market share[1].

Product Launches and Innovations

Recent product launches and innovations have significantly contributed to the market's growth. For example, the launch of LEXETTE™ (halobetasol propionate) Foam 0.05% by Mayne Pharma in 2019 marked a significant milestone. Although not directly related to ULTRAVATE, such innovations in the halobetasol propionate market enhance overall market growth and patient compliance[1].

Market Drivers

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

Increasing Prevalence of Dermatological Conditions

Plaque psoriasis affects approximately 7.5 million Americans, and potent topical corticosteroids like ULTRAVATE are prescribed to about 80% of these patients[1].

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[1].

Market Restraints

Despite the growth, there are several restraints to consider:

Regulatory Hurdles

Regulatory challenges can impact the approval and launch of new formulations.

Side Effects

Topical corticosteroids like ULTRAVATE can have side effects, which may limit their use in some patients[1].

Future Outlook

The future outlook for the halobetasol propionate market, including ULTRAVATE, is positive. 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.

Financial Performance of Key Players

Companies like Sun Pharma, which manufactures ULTRAVATE, are experiencing steady financial performance. For instance, Sun Pharma's overall revenue and market presence continue to grow, supported by a diverse portfolio of pharmaceutical products, including topical corticosteroids like ULTRAVATE[4].

Competitive Landscape

The competitive landscape is intense, with multiple players vying for market share. ULTRAVATE competes with other branded and generic versions of halobetasol propionate, such as LEXETTE and BRYHALI. The competition is driven by factors like product innovation, pricing, and marketing strategies[1].

Regional Growth

North America remains a significant market for ULTRAVATE due to the high prevalence of skin conditions. However, the Asia-Pacific region is expected to show substantial growth, driven by increasing healthcare awareness and expenditure[1].

North America

This region is characterized by a high prevalence of psoriasis and other skin conditions, making it a major market for ULTRAVATE.

Asia-Pacific

This region is expected to grow significantly due to a large patient population and increasing healthcare expenditure.

Product Availability and Formulations

ULTRAVATE is available in various formulations, including cream, lotion, and ointment, each with a strength of 0.05%. These formulations are approved by the FDA and are widely used in the treatment of plaque psoriasis and other skin conditions[4].

Regulatory Approvals

ULTRAVATE has been approved by the FDA in several formulations. For example, the cream and ointment formulations were approved on December 27, 1990, and the lotion formulation was approved on November 6, 2015[4].

Market Impact of Generic Versions

The availability of generic versions of halobetasol propionate can impact the market share of branded products like ULTRAVATE. However, the brand loyalty and the specific formulations offered by ULTRAVATE help it maintain a significant market presence[1].

Conclusion

The market for ULTRAVATE, driven by the demand for halobetasol propionate, is poised for sustained growth. Key factors such as increasing prevalence of dermatological conditions, advancements in formulations, and growing healthcare expenditure are driving this growth.

Key Takeaways

• The global halobetasol propionate market, including ULTRAVATE, 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 Sun Pharma, Glenmark Pharma, and others.
• New product launches and innovations 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. 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].

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[1].

Sources

1. DrugPatentWatch: Halobetasol propionate - Generic Drug Details[1].
2. Ultragenyx: Ultragenyx Reports Preliminary 2023 Revenue; Guidance for 2024 Revenue and Cash Usage; Pipeline Updates and 2024 Milestones[2].
3. Annual Reports: Teligent, Inc. - Annual Reports[3].
4. Drugs.com: Generic Ultravate Availability[4].
5. Ultragenyx: Ultragenyx Reports First Quarter 2024 Financial Results and Reaffirms 2024 Guidance[5].