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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	8
Patent Applications:	5,578
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
Bausch Health Americas, Inc.	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 1

See all ULTRAVATE clinical trials

Pharmacology for ULTRAVATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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		RX	Yes	Yes			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
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990

International Patents for ULTRAVATE

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

Country	Patent Number	Title	Estimated Expiration
Spain	462763
India	4160DEN2015
Austria	363202
Singapore	11201502931Y	TOPICAL STEROID COMPOSITION AND METHOD

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ULTRAVATE

Last updated: July 28, 2025

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Introduction

ULTRAVATE (halobetasol propionate) stands as a high-potency topical corticosteroid indicated primarily for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since its market approval, ULTRAVATE has carved out a significant niche within dermatology, driven by clinical efficacy, regulatory positioning, and evolving market dynamics. This comprehensive analysis explores the current market environment, competitive landscape, regulatory considerations, and the financial trajectory shaping ULTRAVATE's future.

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Market Overview and Segment Positioning

The dermatological segment, notably corticosteroid formulations, commands a substantial share in the global topical drug market, projected to reach USD 15 billion by 2027, expanding at a CAGR of approximately 4% [1]. ULTRAVATE, marketed primarily by Glenmark Pharmaceuticals and other regional players, targets moderate to severe inflammatory skin conditions—psoriasis, eczema, and dermatitis.

ULTRAVATE’s positioning hinges on its status as a high-potency corticosteroid, typically prescribed when milder options prove insufficient. Its pharmacologic profile supports rapid symptom relief, reinforcing patient adherence and physician preference in certain geographies.

In the United States, ULTRAVATE maintains a strong presence owing to its FDA approval as a treatment for corticosteroid-responsive dermatoses. Its competitive landscape includes generics and other high-potency topical steroids like Clobetasol Propionate and Betamethasone Dipropionate.

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Market Drivers Influencing ULTRAVATE

1. Rising Prevalence of Chronic Skin Conditions

The global incidence of psoriasis and atopic dermatitis has increased, attributable in part to environmental factors and heightened diagnosis rates. The National Psoriasis Foundation estimates over 8 million Americans affected, with similar trends globally [2]. Consequently, demand for potent corticosteroids like ULTRAVATE persists, particularly in severe cases unresponsive to milder formulations.

2. Aging Population and Skin Care Awareness

Aging populations, especially in North America and Europe, exhibit increased susceptibility to skin conditions requiring potent management strategies. Moreover, heightened awareness about skin health fosters patient-driven demand for effective treatments, influencing ULTRAVATE sales.

3. Regulatory Approvals and Expedited Access

Regulatory bodies have shown an inclination toward approving innovative formulations or new indications, expanding market reach. While ULTRAVATE’s core indication remains stable, efforts to secure additional approvals or formulations—such as foam or ointment variants—can catalyze growth.

4. Competitive Dynamics and Generics

The patent landscape for ULTRAVATE is a critical factor. Once patents expire, generic competition is poised to intensify, typically leading to price erosion. Glenmark's ability to defend market share or innovate with new delivery systems can significantly affect revenue streams.

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Challenges and Market Risks

1. Safety Profile and Regulatory Scrutiny

High-potency corticosteroids pose risks such as skin atrophy, systemic absorption, and hypothalamic-pituitary-adrenal (HPA) axis suppression. Regulatory agencies have increased scrutiny, especially concerning long-term usage, which may restrict prescribing practices and impact sales.

2. Competitive Formulations and Biosimilars

Emerging bioengineered therapies and advanced topical formulations, including non-steroidal alternatives, challenge ULTRAVATE’s dominance. For example, non-steroid topical immunomodulators such as crisaborole and recent biologic therapies for psoriasis (e.g., adalimumab biosimilars) threaten corticosteroid market share.

3. Geographic Market Limitations

While ULTRAVATE enjoys strong recognition in developed markets, emerging regions exhibit burgeoning dermatology markets but may face regulatory hurdles, reimbursement challenges, and limited healthcare infrastructure, constraining growth.

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Financial Trajectory and Future Outlook

Revenue Trends

Analysis of ULTRAVATE’s historical sales data indicates moderate but steady growth, driven by expanding indications and geographic expansion. In the U.S., ULTRAVATE’s sales have remained resilient despite generic entries, aided by brand loyalty and physician preference. However, the impending patent expiry timelines forecast potential revenue decline unless offset by innovations or new indications.

Impact of Patent Expirations and Generic Competition

The primary patent for ULTRAVATE is expected to lapse within the next 2-3 years. Post patent expiry, the influx of generics is likely to depress prices by up to 70-80%, reducing revenue margins significantly. Glenmark’s strategic response involves launching new formulations or combination therapies to preserve market share and command premium pricing.

Pipeline and Strategic Innovations

Glenmark and other manufacturers are exploring formulations such as foams and gels to enhance patient compliance, especially in pediatric populations. Additionally, investments in formulation innovations targeting specific conditions (e.g., scalp psoriasis) could open new revenue streams.

Market Penetration and Expansion

Emerging markets present a lucrative yet challenging landscape. The growing middle class, increasing healthcare expenditure, and regulatory reforms suggest potential expansion. However, market access strategies, including local manufacturing and partnerships, are crucial for sustainable growth.

Forecasted Financial Trajectory

Based on current trends and strategic initiatives, ULTRAVATE’s revenue outlook suggests a plateau during the immediate post-patent expiry period, followed by a gradual recovery contingent upon innovation and geographic expansion. A projected decline of 20-30% within two years of patent expiration is plausible, with subsequent stabilization driven by new formulations and indications.

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Regulatory and Contractual Considerations

Compliance with regional regulatory pathways influences ULTRAVATE’s market performance. Recent FDA reviews have emphasized safety data, particularly for long-term corticosteroid use. Regulatory agencies in Europe and Asia follow similar standards, affecting the timing of approval and market access.

Contractual agreements with healthcare providers and payers also shape revenue, especially as payers seek biosimilars and generics to reduce costs. Strategic pricing, reimbursement negotiations, and formulary placements are pivotal.

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Conclusion

ULTRAVATE’s market dynamics reflect a complex interplay of clinical efficacy, safety profiles, competitive pressures, regulatory landscapes, and regional healthcare policies. Its financial trajectory, marked by steady revenue supported by clinician preference, faces imminent challenges from patent expiration and generic competition. However, strategic innovations, geographic diversification, and potential label expansions can mitigate revenue erosion and foster renewed growth.

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Key Takeaways

• Market Position: ULTRAVATE remains a leading high-potency corticosteroid for dermatology indications, with significant penetration in North America and Europe.
• Growth Drivers: Rising skin disease prevalence, aging populations, and improved formulations support sustained demand.
• Risks: Patent expiry, safety concerns, and competition from biosimilars and non-steroidal therapies threaten revenue stability.
• Strategic Opportunities: Developing new formulations, expanding into emerging markets, and gaining additional approvals can bolster future earnings.
• Financial Outlook: Revenue likely to decline temporarily post-patent expiration but can stabilize through innovation and market expansion strategies.

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FAQs

Q1: When is ULTRAVATE’s patent expected to expire, and what are the implications?
A1: The primary patent in major markets is projected to expire within 2-3 years, likely leading to increased generic competition, pricing pressures, and potential revenue decline.

Q2: How does ULTRAVATE compare with its competitors in terms of efficacy and safety?
A2: ULTRAVATE’s high potency provides rapid symptomatic relief but carries risks associated with potent corticosteroids. Its safety profile is comparable to other high-potency options, with risks mitigated by appropriate prescribing practices.

Q3: Are there any recent or upcoming formulations of ULTRAVATE that could impact its market?
A3: Yes. Development of foam, gel, and combination formulations aims to enhance patient adherence and expand indications, potentially offsetting losses from patent expiry.

Q4: What role do regulatory agencies play in ULTRAVATE’s market trajectory?
A4: Regulatory agencies influence approval timelines, safety standards, and labeling, directly impacting market access and clinician prescribing patterns.

Q5: What strategic moves should Glenmark consider to sustain ULTRAVATE’s market share?
A5: Investing in formulation innovation, expanding into emerging markets, securing new indications, and establishing strategic alliances are critical strategies.

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References

[1] Reports and projections on the global dermatology drug market, 2022.
[2] National Psoriasis Foundation, 2022.
[3] Regulatory guidelines from FDA and EMA on corticosteroid safety and approval processes.