ENSTILAR Drug Patent Profile

When do Enstilar patents expire, and what generic alternatives are available?

Enstilar is a drug marketed by Leo Pharma As and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-five countries.

The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

DrugPatentWatch^® Generic Entry Outlook for Enstilar

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ENSTILAR

International Patents:	36
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	17
Patent Applications:	121
Drug Prices:	Drug price information for ENSTILAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENSTILAR
What excipients (inactive ingredients) are in ENSTILAR?	ENSTILAR excipients list
DailyMed Link:	ENSTILAR at DailyMed

See drug prices for ENSTILAR

Recent Clinical Trials for ENSTILAR

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

Sponsor	Phase
Psoriasis Treatment Center of Central New Jersey	PHASE4
Lipidor AB	Phase 3
Aarhus University Hospital	Phase 4

See all ENSTILAR clinical trials

Pharmacology for ENSTILAR

Drug Class	Corticosteroid Vitamin D Analog
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ENSTILAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENSTILAR	Topical Foam	betamethasone dipropionate; calcipotriene	0.005%/0.064%	207589	1	2020-06-22

US Patents and Regulatory Information for ENSTILAR

ENSTILAR is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,688,108
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	9,119,781*PED				Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,617,698		Y

Expired US Patents for ENSTILAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	6,753,013

International Patents for ENSTILAR

When does loss-of-exclusivity occur for ENSTILAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ENSTILAR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011264198
Brazil	112012030653
Canada	2800181

Last updated: July 20, 2026

ENSTILAR market dynamics and financial trajectory

ENSTILAR (tacrolimus topical solution, 0.1 mg/mL) is priced and promoted around steroid-sparing, topical calcineurin inhibition for plaque psoriasis, with revenue driven primarily by dermatology channel penetration and payer formulary access. Financial trajectory is constrained by limited prescriber familiarity versus topical corticosteroids and by label-specific uptake that narrows the addressable population compared with broader topical/emollient portfolios.

What is ENSTILAR (tacrolimus topical solution) and how is it positioned in plaque psoriasis?

ENSTILAR is an FDA-approved topical calcineurin inhibitor product for the treatment of plaque psoriasis in non-immunocompromised adults and children (age eligibility varies by label language by region; US labeling is the reference point for US market dynamics). The product competes in a crowded plaque psoriasis topical market where typical comparators include:

• Topical corticosteroids (low cost, broad prescriber habits, fast onset)
• Vitamin D analogs (calcipotriene, calcipotriol)
• Topical calcineurin inhibitors (tacrolimus ointment/cream in other forms, off-label use for psoriasis where applicable)
• Targeted systemics and biologics for patients escalated from topical failure

Positioning logic: ENSTILAR’s differentiation is a steroid-sparing approach that can reduce steroid-related adverse effects and regimen fatigue for patients on chronic topical therapy, especially where clinicians want non-steroidal options.

Which market dynamics matter most for ENSTILAR adoption?

1) Dermatology prescribing inertia Topical psoriasis care is entrenched in corticosteroid-first algorithms. ENSTILAR adoption depends on:

• Dermatologists’ willingness to switch stable patients from steroids to a non-steroidal regimen
• Clinical workflow fit (vehicle, application time, tolerability expectations)
• Patient adherence support (solution application differs from ointment/cream habits)

2) Payer coverage and step therapy Topical psoriasis coverage is often shaped by:

• Step edits requiring failure of preferred low-cost topicals (especially generics)
• Prior authorization thresholds that restrict use to certain severities or refractory disease
• Quantity limits for long-term management

ENSTILAR’s financial performance is therefore sensitive to formulary tier placement and pharmacy benefit manager contracting.

3) Safety and tolerability perceptions Tacrolimus class products drive adoption around:

• Stinging/burning expectations early in therapy
• Continued use once tolerability stabilizes
• Patient education to reduce drop-off in the initial weeks

4) Competitor mix shifts Even if ENSTILAR gains within topical subsegments, overall plaque psoriasis growth can be diluted by systemic and biologic channel share. As payer and guideline emphasis shift toward agents with higher clearance rates, the topical addressable base can plateau.

How does ENSTILAR compare with branded and generic topical plaque psoriasis options?

ENSTILAR’s competitive set is mainly branded/generic topicals plus tacrolimus-containing alternatives in other dosage forms where covered.

Comparison at a high level (commercial impact):

• Versus topical corticosteroids: ENSTILAR is typically less preferred economically, but can win in chronic use cases where steroid safety drives preference.
• Versus vitamin D analogs: ENSTILAR can be an alternative when irritation limits vitamin D analog adherence.
• Versus other tacrolimus formats: ENSTILAR’s solution formulation and its label positioning determine whether it is perceived as more convenient or more tolerable in real-world use.

Featured snippet answer: ENSTILAR wins on steroid-sparing differentiation, but loses on baseline cost and clinician inertia versus corticosteroids in most payer-driven workflows.

What is the revenue trajectory risk profile for ENSTILAR?

Revenue tailwind sources

• Increased dermatologist comfort with calcineurin inhibitors for plaque psoriasis
• Expansion of covered indications (if any in the future) or improved payer access
• Patient retention on long-term non-steroidal topical regimens where steroid avoidance matters

Revenue headwind sources

• Formulary pressure that caps share at a non-preferred tier
• Therapeutic switching to systemic therapies for patients who escalate
• Competitors with cheaper generic availability and stronger payer contracts

Key risk: ENSTILAR’s growth is likely not linear with market category growth because a portion of plaque psoriasis demand shifts to high-cost systemic/biologic therapy as severity rises. That shifts the “plaque psoriasis treating” market away from topical-only management.

When does ENSTILAR face exclusivity or competitive generic pressure?

ENSTILAR’s exclusivity and patent-driven competitive timeline depends on its Orange Book record for the specific US NDA, including:

• Regulatory exclusivity end dates (data exclusivity and any pediatric exclusivity where applicable)
• Patent term and listed patents covering the active ingredient, formulation, or method of use
• Whether any Paragraph IV challenges exist or are anticipated by ANDA filers

Featured snippet answer: The practical generic entry risk is governed by Orange Book-listed patents and the timing of their expiration, not by the overall topical market cycle.

What patent estate issues typically govern ENSTILAR’s generic entry risk?

For topical psoriasis products, generic entry risk is usually constrained by:

• Formulation-specific patents (solvent system, vehicle, stability)
• Delivery and dosing patents (application method, dosing regimen)
• Method-of-use patents (specific treatment regimens, age- or severity-defined indications)
• Combination coverage (if any packaging/device components are patented)

Commercial implication: If the patent estate includes formulation or method-of-use coverage, generic applicants may be forced into design-arounds or litigation, delaying effective launch even after some exclusivity ends.

How strong is ENSTILAR’s patent coverage versus generic threat?

Patent strength for a niche topical depends on:

• How many listed patents remain unexpired after regulatory exclusivity ends
• Litigation history (if any)
• Whether patents are broadly enabling or depend on narrow claim elements

Featured snippet answer: The generic “effective date” is typically the later of (a) expiration of relevant Orange Book patents tied to the proposed ANDA ANDA claims and (b) final resolution of any litigation preventing entry.

What is the Orange Book status of ENSTILAR?

Orange Book status is determinative for:

• Listed patents (numbers and expiration dates)
• Exclusivity codes and end dates
• Which patents are “relevant” for generic applicants filing with paragraph IV certifications

Featured snippet answer: Orange Book listings define the legally actionable patent and exclusivity landscape for ANDA/505(b)(2) competitors targeting tacrolimus topical solution.

What generic entry risks exist for ENSTILAR?

Generic entry risks typically come in two phases:

1. ANDAs filed during exclusivity, pending patent resolution
2. Launch after patents/exclusivity that block entry expire or are cleared

Commercial consequence: Even if exclusivity ends, brand erosion depends on whether competitors can launch lawfully and whether payers move to preferred status quickly.

What Paragraph IV challenges or patent litigation affect ENSTILAR?

Patent litigation affects market dynamics through:

• Automatic stay (if Paragraph IV is successful in delaying approvals)
• Settlement terms that can delay launch via agreed “effective dates”
• Design-around strategies that can create non-interchangeable products

Featured snippet answer: ENSTILAR’s downside scenario for revenue is driven by any Paragraph IV-based challenge outcomes and settlement-triggered launch calendars.

How do FDA regulatory milestones shape ENSTILAR’s financial trajectory?

Key determinants include:

• Post-approval label expansions (if any)
• Safety communications or labeling changes that influence prescriber adoption
• Changes in manufacturing or supply chain stability

For topical products, supply continuity can be a direct revenue factor because dermatology demand can be sensitive to intermittent shortages or backorders, especially for chronic use patients.

How do manufacturing/IP barriers influence ENSTILAR supply and launch economics?

For topical calcineurin inhibitors, manufacturing barriers include:

• Consistency of vehicle and dosing uniformity
• Stability of tacrolimus within the solution matrix
• Container closure system performance and compatibility

These factors drive COGS and risk for generic developers. If formulation replication is technically harder, it can increase launch delay and legal exposure.

Which companies are likely competitors or challengers to ENSTILAR in US dermatology topical care?

In the topical psoriasis arena, competitive pressure is broad:

• Established topical psoriasis brands and their authorized generics
• Generic manufacturers with dermatology portfolios
• Brands in overlapping topical/dermatology categories that buy formulary space with rebate strength

Featured snippet answer: The biggest commercial threat usually comes from the lowest net-price topical that wins payer preference, not necessarily from the most clinically similar product.

What commercial KPIs would indicate whether ENSTILAR is gaining share?

For a topical psoriasis product, real trajectory is typically evidenced by:

• Pharmacy claims growth (Rx volume) versus category totals
• Net-to-gross (rebate intensity) changes reflecting payer competitiveness
• Persistence and re-fill behavior for chronic topical regimens
• Share of prescriptions versus steroid/tacrolimus alternative formats
• Share within payer segment cohorts (commercial vs Medicare Part D)

ENSTILAR revenue exposure: what drives upside vs downside?

Upside scenario

• Better payer placement and expanded prescriber comfort in steroid-refractory or steroid-avoidant patients
• Increased penetration into psoriasis treatment lines where dermatologists prefer steroid-sparing topical regimens
• Sustained supply and predictable ordering

Downside scenario

• Intensified step edits that push it down payer tiers
• Competitive replacement by generic corticosteroids and generic vitamin D analogs at lower net prices
• Escalation of systemic therapy share for eligible patients

Key takeaways

• ENSTILAR’s market dynamics are dominated by dermatology prescribing inertia and payer access more than by clinical differentiation alone.
• Financial trajectory is sensitive to formulary tiering, prior authorization patterns, and net-price erosion relative to low-cost topical generics.
• Generic entry timing depends on Orange Book-listed patents and exclusivity, not on the general psoriasis market cycle.
• The largest revenue risks are payer-driven restriction and shifts from topical management to systemic/biologic therapy for patients with higher severity.

FAQs

1) Does ENSTILAR compete primarily with topical corticosteroids or with systemic psoriasis therapies?

Predominantly with topical corticosteroids and other topical classes within dermatologist-prescribed regimens, with systemic therapies indirectly influencing overall patient pool movement as severity escalates.

2) What payer levers most affect ENSTILAR net revenue?

Formulary tier status, step edits requiring prior treatment failures, prior authorization frequency, and rebate structures tied to volume.

3) What dosage-form or formulation factors could delay tacrolimus topical generic entry?

Vehicle composition, tacrolimus stability, dosing uniformity, and container closure system performance that affects bioavailability and product reproducibility.

4) How do settlement agreements typically change the effective date of generic ENSTILAR products?

They can define a contractually agreed “launch” date even where some exclusivity has expired, preventing immediate entry and preserving brand exclusivity beyond statutory end points.

5) What would signal that ENSTILAR is being displaced by generics in practice?

A faster-than-category decline in Rx volume share, increasing net-to-gross rebates, and formulary removals or tighter step therapy requiring documented failure of preferred generics.

References

1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drug Approval Package and label information for ENSTILAR (tacrolimus topical solution), NDA records.

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