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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULTRAVATE

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

International Patents for ULTRAVATE

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

Country	Patent Number	Title	Estimated Expiration
Austria	363202
German Democratic Republic	133150	VERFAHREN ZUR HERSTELLUNG VON MEHRFACH HALOGENIERTEN STEROIDEN
Hong Kong	16683	21-HALOGENOPREGNANE COMPOUNDS
Malaysia	8400092	21 HALOGENOPREGNANE COMPOUNDS
Switzerland	632000	Process for the preparation of polyhalogenated steroids
Australia	508224
Cyprus	1178	21-HALOGENOPREGNANE COMPOUNDS

Last updated: April 25, 2026

ULTRAVATE: Investment Scenario and Fundamentals Analysis

What is ULTRAVATE in the market?

ULTRAVATE is a topical prescription corticosteroid product used for inflammatory dermatoses. Commercial performance is driven by (1) dermatology access and payer coverage, (2) class competition among topical corticosteroids, (3) generic entry risk around strength/formulation, and (4) prescriber behavior for steroid potency selection.

Active ingredient (drug substance): Halobetasol propionate
Drug class: Topical corticosteroid
Clinical use framing (label-driven): Inflammatory skin conditions responsive to high-potency topical steroids (e.g., steroid-responsive dermatoses)

Who owns and sells ULTRAVATE?

ULTRAVATE is marketed in the U.S. by Bausch Health (brand ownership in the U.S. varies by geography and channel, but the U.S. product is associated with Bausch Health’s portfolio).

How is the product positioned versus class peers?

ULTRAVATE competes in a crowded high-potency topical steroid segment where differentiation is mostly practical:

• Formulation feel and vehicle (ointment vs cream, viscosity, spreadability)
• Strength and regimen (application frequency)
• Coverage and prior authorization patterns
• Generic availability for halobetasol propionate strengths and dosage forms

In investment terms, ULTRAVATE’s fundamentals are less about patent exclusivity on the drug substance and more about brand survival against generics and formulary erosion, plus any advantages tied to packaging, vehicle, and contracted payer access.

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What is the patent and exclusivity landscape that matters?

Topical corticosteroids like halobetasol propionate have historically faced generic pressure. For an investment view, the key question is not whether patents exist somewhere, but whether ULTRAVATE’s commercial moat is protected through:

• Composition-of-matter patents on halobetasol propionate (if still active)
• Formulation patents specific to ULTRAVATE’s vehicle and strength
• Method-of-use patents (less common as real barriers for topical steroid prescribing)
• Exclusivities (e.g., pediatric, orphan, market exclusivity), which are typically limited for legacy molecules and topical generics

For current decision-grade analysis, the patent wall must be tied to specific ULTRAVATE NDCs and their listed patent terms through the U.S. patent listing system (Orange Book). Without that mapping, any “patent moat” claim becomes non-actionable.

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What are the key commercial drivers and bottlenecks?

1) Dermatology prescribing dynamics

High-potency topical steroids are typically prescribed when lower potency steroids fail. Prescribers choose based on:

• Severity and body site
• Duration of therapy (high potency generally used for limited courses)
• Patient adherence (vehicle usability)
• Cost and coverage

Brand revenue is therefore sensitive to payer policy and plan formularies that often favor lower-cost generics.

2) Payer coverage and reimbursement

Investment-grade risk sits in:

• Formulary tier placement: branded products trend to non-preferred status
• Step edits / prior authorization: brands can be restricted unless specific criteria are met
• Copay and channel: changes in pharmacy benefit design can shift demand to generics quickly

3) Safety and labeling constraints

Systemic absorption and local adverse effects drive conservative use patterns. ULTRAVATE’s commercial life depends on:

• Maintenance of labeling that aligns with current standard of care
• No new safety signals that tighten restrictions

For topical steroids, the market does not expand much without clinical guideline changes; most growth comes from share shifts and access.

4) Generic substitution pressure

Halobetasol propionate topical steroids have extensive generic presence in many markets. The investment question is whether ULTRAVATE maintains:

• Vehicle-specific differentiation (if exclusivity exists on specific formulation/NDCs)
• Contracted pharmacy network retention
• Switching resistance through prescriber behavior and patient history

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How should investors underwrite ULTRAVATE fundamentals?

A practical underwriting framework focuses on brand sales durability and competitive intensity rather than R&D pipeline optionality.

Unit economics logic

ULTRAVATE’s margin profile is influenced by:

• Gross-to-net pressure under PBM contracting
• Stability of rebate exposure versus generics
• Buy-and-bill intensity is not relevant for topical; distribution costs are lower, but PBM rebates are the main drag

Scenario model structure (high-level)

Use three cases driven by generic erosion speed:

1. Base case: slow share loss (formulary preference remains modestly favorable)
2. Downside: accelerated substitution due to payer policy shifts and competitive launches
3. Upside: sustained brand access plus better-than-expected persistence of specialty dermatology prescribing

The model inputs should include:

• Market share drift vs high-potency topical steroid class
• Price erosion assumptions and gross-to-net trends
• Volume elasticity after formulary status changes

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What valuation signals are most relevant?

For mature topical brands, investors should prioritize:

• Revenue durability (decline slope vs class baseline)
• Gross-to-net trend (rebate pressure is often a leading indicator of switching)
• Distribution and channel stability
• Any remaining exclusivity mapped at the NDC level
• Litigation outcomes affecting market launch timing (if applicable)

Without current Orange Book and NDC patent-to-expiration mapping, any valuation commentary tied to specific protection dates is non-actionable.

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Key takeaways

• ULTRAVATE is a mature high-potency topical corticosteroid brand (halobetasol propionate) whose fundamentals depend on brand access, payer coverage, and resistance to generic substitution.
• Investment risk concentrates in formulary erosion and gross-to-net pressure, not in clinical R&D upside.
• Any credible moat hinges on NDC-specific patent and exclusivity status, which must be mapped via Orange Book listings and current litigation outcomes.
• Best underwriting lens is sales durability and competitive intensity across high-potency topical corticosteroids, using scenario models driven by generic erosion speed.

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FAQs

1. What drug is ULTRAVATE?
   ULTRAVATE is a topical prescription corticosteroid with active ingredient halobetasol propionate.

2. What market does ULTRAVATE serve?
   It is used for steroid-responsive inflammatory skin conditions, managed through topical dermatology prescribing.

3. What is the biggest investment risk for ULTRAVATE?
   Generic substitution and payer formulary pressure that drives share loss and increases rebate pressure.

4. What drives ULTRAVATE revenue most?
   Payer access, formulary placement, and prescriber behavior for choosing high-potency topical steroid therapy.

5. What determines whether ULTRAVATE has long-term protection?
   NDC-level patent and exclusivity status and any litigation that affects generic launch timing.

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References

[1] Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
[2] ULTRAVATE (halobetasol propionate) prescribing information. FDA label. https://www.accessdata.fda.gov/