PICATO Drug Patent Profile

Which patents cover Picato, and when can generic versions of Picato launch?

Picato is a drug marketed by Leo Labs and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.

DrugPatentWatch^® Generic Entry Outlook for Picato

Picato was eligible for patent challenges on January 23, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2027. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases 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.

There is one tentative approval for the generic drug (ingenol mebutate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for PICATO

International Patents:	35
US Patents:	12
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	19
Patent Applications:	1,045
Drug Prices:	Drug price information for PICATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PICATO
What excipients (inactive ingredients) are in PICATO?	PICATO excipients list
DailyMed Link:	PICATO at DailyMed

See drug prices for PICATO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PICATO

NDA:

202833

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PICATO

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

Sponsor	Phase
Instituto Nacional de Cancer, Brazil	Phase 1/Phase 2
Center for Clinical Studies, Texas	Early Phase 1
LEO Pharma	Early Phase 1

See all PICATO clinical trials

Paragraph IV (Patent) Challenges for PICATO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PICATO	Gel	ingenol mebutate	0.05%	202833	2	2016-01-27

US Patents and Regulatory Information for PICATO

PICATO is protected by twelve US patents.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y

Expired US Patents for PICATO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012

EU/EMA Drug Approvals for PICATO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LEO Laboratories Ltd.	Picato	ingenol mebutate	EMEA/H/C/002275Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.	Withdrawn	no	no	no	2012-11-15

International Patents for PICATO

When does loss-of-exclusivity occur for PICATO?

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

Australia

Brazil

Canada

Cyprus

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

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 PICATO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	397580
Australia	736230
Australia	8721798
Australia	PO864097
Brazil	9811327

Supplementary Protection Certificates for PICATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	C300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877	PA2014030	Lithuania		PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
1988877	CA 2014 00042	Denmark		PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121119
1988877	C20140025 00111	Estonia		PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1015413	C300592	Netherlands		PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115

Last updated: July 22, 2026

PICATO (ingenol mebutate) market dynamics and financial trajectory

PICATO (ingenol mebutate) is a niche, dermatology-focused product with declining commercial relevance driven by limited label scope, competitive branded alternatives in actinic keratosis (AK) and seborrheic variants, and execution risk tied to dosing/field-of-use specificity. From a patent and regulatory exclusivity perspective, the product is effectively past peak life-cycle leverage, leaving revenue more exposed to generic and private-label substitution dynamics in primary care dermatology flows where payer and formulary decisions dominate.

What matters commercially

• Primary indication: actinic keratosis (AK) lesions, with a discrete dosing schedule and lesion treatment window.
• Revenue driver: lesion volumes in outpatient dermatology, constrained by treatment adherence and lesion count/treatment-area fit.
• Downstream pressure: shifting prescriber preference toward newer topical regimens with broader perceived convenience and durability in real-world use.
• Financial trajectory: mature branded profile with material downside risk from substitution once payers broaden tier placement.

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How has PICATO performed financially since launch?

Answer (directional): PICATO is in late life-cycle commercialization, with revenue trending down rather than scaling. Market positioning has narrowed as competitors expanded dermatology AK portfolios and as insurers favored alternative regimens under formulary management.

Revenue trajectory drivers

1. Niche usage pattern
   • AK is common, but PICATO’s differentiation is tied to topical application workflows (field size fit and time-to-application), which affects adoption.
2. Prescriber switching
   • Dermatology treatment decisions increasingly incorporate office practice protocols and payer-preferred “step edits” for topical AK therapy.
3. Payer pressure
   • Topical dermatology brands face tiering based on net price. When net reimbursement erodes, uptake declines even if gross demand remains stable.
4. Product lifecycle
   • Engineering brand value around short-course topical therapy often works early, but long-term share retention depends on sustained outcomes, tolerability differentiation, and payer stability. Over time, economics usually favor lower-cost equivalents.

Commercial KPIs to monitor

• TRx and prescriptions by geography (U.S. outpatient trends).
• Channel mix (retail vs specialty pharmacy distribution patterns).
• Net price and rebate compression (systematically predicts share erosion).
• Formulary status (tier placement, prior authorization criteria).

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What market forces drive PICATO demand in actinic keratosis treatment?

Answer (directional): Demand is driven by lesion incidence and dermatology visit volumes, then constrained by treatment protocol fit, tolerability outcomes, and payer coverage.

Competitive dynamics in topical AK

• Branded-to-branded substitution: in-office and community dermatology often switches within topical AK classes based on regimen simplicity and patient tolerance.
• Payer-led switching: formulary moves away from higher cost per course once alternatives are preferred by managed care.
• Real-world adherence: short-course products still face adherence failure if patients dislike local skin reactions or if clinician follow-up is inconsistent.

Key demand sensitivities

• Lesion count distribution among treated patients (field vs lesion-by-lesion approach affects match).
• Seasonality and sun exposure patterns (AK diagnosis cycles).
• Patient comorbidity profile (tolerability and risk of dermatitis can shift treatment selection).

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What is the Orange Book status of PICATO and what does it imply for future competition?

Answer (directional): PICATO is not expected to sustain new exclusivity-based pricing power; availability risk for generic alternatives and therapeutic substitutes increases as branded patents age out and regulatory exclusivity periods expire.

How to map PICATO to exclusivity risk

• Patent estate aging: as primary patents reach expiry, Paragraph IV filing risk rises for any chemistry/manufacturing or formulation blocking patents still active.
• Regulatory substitution: even without direct AB-generic launch parity, class switching can erode brand demand.

(No Orange Book listing or patent identifiers are provided in the available input, so the timeline and specific listings cannot be enumerated here.)

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Which patents protect PICATO and how strong is the patent estate?

Answer (directional): PICATO’s patent protection is consistent with a mature branded topical product in a crowded topical AK landscape. Estate value typically concentrates in specific formulations, dosing regimens, or manufacturing controls, which may delay but not fully prevent market erosion once the core compound and early composition claims expire.

Patent estate components that matter commercially

• Formulation and delivery system patents
  • Controls around topical stability, gel characteristics, and dosing uniformity.
• Manufacturing and process patents
  • If still active, can create IP barriers to generic scale-up or changes in manufacturing controls.
• Method-of-use claims
  • If active, can drive litigation risk for generic labeling carve-outs and “skin reaction” endpoints.

(No patent numbers or assignees are provided in the available input, so specific claim-by-claim strength cannot be compiled.)

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Is PICATO exposed to Paragraph IV challenges or biosimilar risk?

Answer (directional): Biosimilar risk is not applicable to PICATO because it is a small-molecule topical drug, not a biologic. The relevant competitive litigation pathway is generic small-molecule substitution risk, including Paragraph IV challenges where a generic application targets protected claims.

What to check for generic entry risk

• Whether active patents are listed in the FDA Orange Book for PICATO.
• Whether any follow-on patents still have enforceable term covering formulation, method of use, or manufacturing.
• Whether ANDA sponsors have initiated litigation (case dockets for PICATO-related disputes).

(No litigation case list or Orange Book patent identifiers are provided in the available input.)

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When does PICATO lose exclusivity and what is the launch timing risk for generics?

Answer (directional): PICATO’s exclusivity-based leverage is largely exhausted in late life-cycle, so generic launch timing risk depends more on remaining formulation/process/method patents (if any) than on broad compound exclusivity.

Timing framework

• Compound and primary composition expiry: usually early in lifecycle for older dermatology agents.
• Secondary patents: formulation/process and specific instructions extend, but typically do not stop competition indefinitely.
• Regulatory data exclusivity: applies mainly at initial approval and is often already fully elapsed for a mature product.

(No specific expiry dates or exclusivity end dates are included in the available input.)

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What formulations are protected for PICATO and how does that affect generic switching?

Answer (directional): Formulation protection (topical gel characteristics) can affect generic acceptability and delay entry if controlled claims remain enforceable. Even when generics can be approved on bioequivalence, patent carve-outs or litigation can shape time-to-market and payer adoption.

Practical impact on payers and prescribers

• Skin reaction profile and tolerability expectations are often used by clinicians to select a topical AK regimen.
• Dosing schedule fit determines “course completeness,” which influences clinician preference and patient follow-through.
• Equivalent appearance and spreading properties affect perceived efficacy.

(No PICATO-specific patent/formulation list is available in the provided input.)

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How does PICATO compare with competing topical actinic keratosis treatments on market positioning?

Answer (directional): PICATO competes in a topical AK bundle where prescribers often select based on local protocols, tolerability, and dosing experience. Market share shifts when competitors introduce smoother patient journeys, broader regimen flexibility, or stronger payer coverage.

Competitive comparison dimensions

• Course length and application convenience
• Expected local skin reactions
• Patient persistence and treatment completion
• Payer coverage and net price
• Clinical protocol alignment (dermatology practices standardize workflows)

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What settlement or litigation outcomes could reshape PICATO revenue?

Answer (directional): For mature topical products, settlements and non-infringement outcomes primarily affect the calendar timing of generic entry and the label scope. Earlier-than-expected resolution compresses brand net price, while delayed resolution preserves tighter competition for longer.

Litigation levers

• Carve-out design in settlement agreements
• Launch date commitments
• Dismissal terms
• Bundled licensing for authorized generics

(No PICATO litigation docket details are provided in the available input.)

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How sensitive is PICATO revenue to payer formulary and reimbursement changes?

Answer (directional): High. Topical branded dermatology products are strongly impacted by formulary tiering, prior authorization criteria, and rebate dynamics because prescribers can switch therapies within the same class during prescribing decisions.

What usually changes net revenue fastest

• Formulary down-tiering (commercial and Medicare Part D impact)
• Prior authorization tightening
• Contract re-trading that lowers net price
• Step therapy adoption that delays access for “non-preferred” products

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Where can PICATO still win commercially despite late life-cycle competition?

Answer (directional): PICATO can sustain revenue only where it retains formulary positioning and where clinician behavior favors its dosing experience and patient outcomes over alternatives.

Commercial niches

• Practices with established AK protocols that already incorporate PICATO
• Patients who tolerate the local skin reaction profile better than alternatives
• Regions with stable payer coverage and limited use of step edits

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Key Takeaways

• PICATO is a mature topical dermatology product with demand tied to AK lesion volumes and constrained by regimen fit, tolerability expectations, and payer coverage.
• Financial trajectory is late life-cycle and downside-biased, driven by branded-to-branded and payer-led substitution.
• Generic and competitive risk is primarily about remaining patent life for formulation/process/method claims and the calendar timing of generic entry, not biosimilar pathways.
• Revenue sensitivity is high to formulary placement and net price compression, which typically accelerates decline once payers down-tier.

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FAQs

1. What payer patterns most affect PICATO net sales in dermatology?
2. How do real-world treatment completion and local skin reaction rates influence PICATO persistence versus other topical AK regimens?
3. What labeling and dosing constraints limit PICATO adoption in actinic keratosis treatment pathways?
4. How do settlement terms in small-molecule topical AK ANDA cases typically impact launch timing and brand price erosion?
5. What competitive strategies help late life-cycle topical brands defend formulary placement?

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References (APA)

1. [No source citations were provided in the available input.]

DrugChatter Q&A for PICATO

What are the side effects of Picato?