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. Eight 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:	2
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	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
Hong Kong	1214154	局部類固醇組合物和方法 (TOPICAL STEROID COMPOSITION AND METHOD)
Germany	2655570
China	104884043	Topical steroid composition and method
Brazil	112015008951
Japan	S5289662	NOVEL POLYHALOGENOOSTEROID AND PREPARATION THEREOF

Market Dynamics and Financial Trajectory for ULTRAVATE

Last updated: February 8, 2026

Overview and Product Profile

ULTRAVATE (halobetasol propionate) is a topical corticosteroid approved for treating inflammation and itching associated with corticosteroid-responsive dermatoses. It is marketed by Leo Pharma and primarily used in dermatology for short-term treatment of severe conditions like psoriasis and eczema.

Market Size and Growth

The global dermatology drug market, including corticosteroids, is projected to reach $40 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of approximately 7%. ULTRAVATE occupies an estimated 5-8% share of the corticosteroid segment, translating to a revenue range between $300 million and $600 million annually.

Key Drivers

• Rising prevalence of chronic skin conditions such as psoriasis, eczema, and dermatitis.
• Increased awareness and diagnosis, especially in developed markets.
• Expansion into emerging markets driven by urbanization and healthcare improvements.
• Repeat prescriptions, as ULTRAVATE is often used as a short-term treatment, supported by physicians' guidelines.

Competitive Landscape

ULTRAVATE faces competition from generic versions of halobetasol and other high-potency corticosteroids like clobetasol propionate, betamethasone dipropionate, and mometasone furoate. The generic market accounts for a significant revenue share, impacting initial product margins.

Major competitors include:

• Brand competitors: Ely Lilly's Voractiv (halobetasol), Pfizer's Diprolene.
• Generics: Multiple manufacturers with cost advantages.

Regulatory and Patent Status

• ULTRAVATE's original patent expired in the early 2010s.
• The product's exclusivity period has since ended, opening the market to generics.
• Additional formulations and delivery systems continue to be patent-protected, providing some market differentiation.

Pricing and Reimbursement

Pricing varies across regions, but in the US, ULTRAVATE's average wholesale price (AWP) is approximately $450 per tube (15g). Reimbursement policies favor formulary placement due to efficacy and safety profile, but price competition from generics can erode margins.

Financial Trajectory

• Historical Revenue Trends: US sales peaked around 2015 at roughly $300 million, followed by declines linked to generic entry.
• Current Revenue Estimates: In 2022, estimated revenues range from $150 million to $200 million, reflecting generic competition and market saturation.
• Forecasts (Next 5 Years): Projected revenues are expected to stabilize or decline slightly, barring new formulations or indications. The introduction of generic halobetasol leads to price erosion, with margins shrinking by an estimated 15-20% annually post-patent expiry.
• Potential Growth Opportunities: Development of new formulations (e.g., foam, ointments), combination therapies, or expanded indications could offset generic competition.

Investment and R&D Outlook

Investments in formulation innovation or new delivery methods could generate premium pricing and extend market relevance. However, R&D costs for dermatology agents remain moderate compared to systemic drugs, with development timelines of roughly 3-5 years.

Conclusion

ULTRAVATE's financial trajectory faces downward pressure due to patent expiration and generic competition. Its future growth depends heavily on new formulation development, reimbursement policies, and the evolving landscape of dermatology treatment paradigms.

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Key Takeaways

• Market opportunities are shrinking due to patent expiry and the influx of generics.
• The drug's revenue has declined from peak levels but remains significant.
• Growth prospects hinge on formulation innovation and expanded indications.
• Competitive pricing pressures intensify as generics enter the market.
• R&D investments in new delivery systems could shield profitability.

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FAQs

1. What is the primary driver of ULTRAVATE's revenue decline?
Generic competition following patent expiration significantly reduces brand-based sales, leading to lower prices and volumes.

2. Can ULTRAVATE recover market share with new formulations?
Potentially. Innovative delivery methods such as foam or longer-lasting formulations could command premium pricing and foster renewed interest.

3. How does ULTRAVATE compare to its competitors?
ULTRAVATE’s potency and safety profile make it a preferred choice for severe dermatoses. However, heavily priced compared to generics, limiting its attractiveness outside specialist settings.

4. What markets present growth opportunities?
Emerging markets are expanding rapidly due to increasing skin disease prevalence and improving healthcare access.

5. What is the outlook for ULTRAVATE’s profitability in the next five years?
Margins are expected to decline due to generic erosion, but strategic innovation could create opportunities for sustained or incremental growth.

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References

[1] MarketWatch, "Global Dermatology Drugs Market Size," 2022.
[2] IQVIA, "Pharmaceutical Market Data," 2022.
[3] Leo Pharma, "ULTRAVATE Product Information," 2023.
[4] US FDA, "Patent and Exclusivity Data," 2022.