VTAMA Drug Patent Profile

When do Vtama patents expire, and when can generic versions of Vtama launch?

Vtama is a drug marketed by Organon Llc and is included in one NDA. There are twelve patents protecting this drug.

This drug has eighty-one patent family members in thirty-nine countries.

The generic ingredient in VTAMA is tapinarof. One supplier is listed for this compound. Additional details are available on the tapinarof profile page.

DrugPatentWatch^® Generic Entry Outlook for Vtama

Vtama was eligible for patent challenges on May 23, 2026.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VTAMA

International Patents:	81
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	275
Drug Prices:	Drug price information for VTAMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VTAMA
What excipients (inactive ingredients) are in VTAMA?	VTAMA excipients list
DailyMed Link:	VTAMA at DailyMed

See drug prices for VTAMA

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

Constraining patent/regulatory exclusivity:

10,647,649

NDA:

215272

Dosage:

CREAM;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.

Pharmacology for VTAMA

Drug Class	Aryl Hydrocarbon Receptor Agonist
Mechanism of Action	Aryl Hydrocarbon Receptor Agonists

US Patents and Regulatory Information for VTAMA

VTAMA is protected by fourteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,647,649.

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
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	11,590,088
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	10,195,160		Y
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	12,569,453
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	11,458,108		Y

International Patents for VTAMA

When does loss-of-exclusivity occur for VTAMA?

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

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

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 VTAMA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	104699
Australia	2016263161
Australia	2019203627
Brazil	112017024934
Canada	2986251

VTAMA (tapinarof) market dynamics and financial trajectory: exclusivity, competition, pricing, and revenue risk

Last updated: June 1, 2026

What is VTAMA (tapinarof) and how is it performing commercially?

VTAMA is a topical aryl hydrocarbon receptor (AhR) modulator indicated for plaque psoriasis in adults. The branded launch created a high-priced, category-disruptive “non-steroid, non-calcipotriol” positioning versus topical corticosteroids and vitamin D analogs. The financial trajectory has been shaped by (1) rapid early uptake constrained by prescriber conversion and payer controls, (2) ongoing expansion of formulary coverage, and (3) competitive pressure from other topical and pipeline entrants targeting similar patient segments.

Commercial framing that drives revenue

Revenue trajectory in topical dermatology typically depends on:

• Net price and rebates tied to plan formularies and channel inventory practices
• Prescription demand driven by prescriber behavior and patient adherence to daily application
• Payer restriction dynamics, including step edits and prior authorization (PA)
• Share stability as new topical launches add “therapeutic switching” pressure

How does VTAMA’s patent and exclusivity timeline affect market share and revenue visibility?

VTAMA’s defensibility is driven by the combination of patent term and regulatory exclusivity periods for the small-molecule New Chemical Entity (NCE) and by any method-of-use and formulation protections (including process claims supporting manufacturing). These protections determine when generics can enter and how aggressively challengers can compete.

When does VTAMA lose exclusivity?

Featured-snippet level answer: VTAMA’s timeline is governed by the expiration of its last relevant U.S. patent(s) plus any applicable FDA exclusivity, with additional risk from paragraph IV litigation if the Orange Book lists multiple listed patents.

Key question for financial planning

• Does the Orange Book list multiple independent patent blocks (compound, formulation, method-of-use, and/or manufacturing/process)?
• Does any block have earlier expiration that enables “at-risk” generic competition even if other patents remain?

What patents protect VTAMA (tapinarof) in the U.S., and how many are listed for FDA approval?

Market impact is highly sensitive to how many patents appear on the FDA Orange Book for tapinarof and whether they are tied to:

• Strength and dosage form (formulation patents)
• Specific regimen or use (method-of-use patents)
• Manufacturing processes (process patents)

Patent estate mapping for risk scoring

A complete, litigation-grade mapping requires the Orange Book patent list with:

• patent numbers,
• assignees,
• expiration dates,
• exclusivity codes,
• and any listed patents tied to specific formulations/strengths.

No complete Orange Book-backed dataset is available in this prompt, so a precise count, patent numbers, and expiration dates cannot be produced.

What Orange Book status does VTAMA (tapinarof) have?

Orange Book status determines whether generics can file:

• ANDA with paragraph IV certifications against listed patents
• or section viii carve-outs if the generic can design around.

No Orange Book listing content (patent numbers, expiration dates, exclusivity codes) is included in this prompt, so Orange Book status cannot be stated with patent-grade specificity.

Which companies are challenging VTAMA, and what is the paragraph IV and litigation record?

Paragraph IV challenges are the leading indicator for:

• near-term competitive entry,
• settlement timing,
• and forecast step-down risk to peak sales assumptions.

This prompt does not include the identities of any ANDA challengers, any district court filings, or settlement dates. A litigation-grade answer cannot be produced without that record.

How does VTAMA compare with competing topical psoriasis therapies on the market?

VTAMA’s competitive set spans multiple treatment classes that differentially influence payer behavior and prescriber switching:

Competitive axes

• Class positioning: AhR modulator vs topical corticosteroids, vitamin D analogs, and combination regimens
• Payer and guideline alignment: formulary placement vs step edits
• Efficacy and tolerability: adoption depends on rapid onset and patient-perceived skin improvement
• User behavior: once-daily regimen tends to support adherence

What matters for market share capture

In topical psoriasis, branded share gains tend to slow when:

• patient populations saturate,
• cost-sharing barriers rise,
• and competing products improve formulary access or deliver similar outcomes with lower co-pays.

What generic entry risks exist for VTAMA, including at-risk timelines?

Generic entry risk is determined by:

• earliest expiration of any Orange Book listed patent block,
• strength-specific formulation protections,
• and whether any patent block is actively litigated or subject to FDA forfeiture triggers.

Because no Orange Book data and no litigation record is included, a time-bounded at-risk scenario cannot be stated.

How do manufacturing and formulation patents for tapinarof create IP barriers?

For topical small molecules, IP barriers can include:

• formulation composition (vehicle, stabilizers, concentration),
• process controls (mixing, milling, sterilization or handling steps as applicable),
• and stability claims for shelf-life.

Without the specific formulation and process patent list for tapinarof, the magnitude of manufacturing IP barriers cannot be quantified.

What regulatory pathway milestones affect VTAMA’s market access and growth?

For a marketed topical product already approved, the regulatory levers that influence financial trajectory are usually:

• label expansions that broaden eligible populations,
• REMS changes (rare for topical small molecules),
• and ongoing FDA safety updates.

This prompt contains no FDA milestone table (supplement approvals, label expansion dates). A regulatory milestone-driven revenue forecast cannot be produced.

What financial trajectory metrics matter most for VTAMA (tapinarof) in quarterly reporting?

For a branded topical dermatology asset, market dynamics typically show up first in:

• U.S. net sales trend (and seasonality if relevant)
• Prescription and script growth (often proxied by pharmacy data)
• Gross-to-net rate (rebates and chargebacks)
• Channel inventory and re-order cadence

How to read VTAMA’s market trajectory in practice

• If script growth outpaces net sales growth: pricing/rebate pressure is rising.
• If net sales fall without script declines: payer mix and formulary access have worsened.
• If both scripts and net sales decline: competitive switching or adherence issues are likely.

No VTAMA financial statements or segment disclosures are provided in this prompt, so numeric net sales, growth rates, and gross-to-net trends cannot be stated.

How sensitive is VTAMA revenue to payer coverage and formulary dynamics?

Topical psoriasis payers often implement:

• PA requirements,
• quantity limits,
• step therapy between topical non-steroid options and corticosteroids,
• and preferred formulary positioning.

A revenue model therefore needs:

• historical formulary adoption by plan type,
• net price by channel,
• and Medicare Part D impact (if applicable to the product’s patient mix).

This prompt provides no claims, payer mix, or formulary adoption data.

What settlement or licensing deals could change VTAMA’s competitive timetable?

Brand manufacturers sometimes settle ANDA litigation to:

• delay launch of generic challengers,
• define “design-around” boundaries,
• and sometimes pay royalties or enter licensing agreements.

Because no litigation docket, settlement agreements, or royalty terms are included here, settlement-driven timetable changes cannot be quantified.

Key timeline: exclusivity, patent expiration, and plausible market entry scenarios

A financial trajectory depends on the earliest “clean” launch date available to competitors. A correct timeline must be anchored to:

• Orange Book patent expiration dates,
• FDA exclusivity expiration dates,
• and litigation-triggered launch offsets.

This prompt lacks the Orange Book patent expiration and exclusivity dataset, so a factual timeline cannot be constructed.

Key Takeaways

• VTAMA’s market dynamics hinge on payer formularies, script demand, and gross-to-net compression typical of branded topical dermatology.
• Financial trajectory risk is most sensitive to the Orange Book patent estate and any paragraph IV litigation that accelerates generic entry.
• This prompt does not include Orange Book listings, patent numbers, exclusivity dates, litigation records, or financial disclosures needed to produce a patent-grade exclusivity timetable or quantified revenue trajectory.

FAQs

1. How does an Orange Book “first-expiration” patent block determine when a generic can launch?
2. What is the difference between NCE exclusivity and patent term in forecasting branded topical revenue?
3. How do gross-to-net and rebate pressure typically evolve after initial uptake for branded topical dermatology drugs?
4. What litigation events most often shift settlement timelines in ANDA paragraph IV cases for topical drugs?
5. Which formulary tactics (PA, step edits, quantity limits) most directly impact branded topical psoriasis market share?

References

No sources were provided in the prompt, and no Orange Book, litigation, or financial statement citations can be generated from the information given.

DrugChatter Q&A for VTAMA

Vtama cost with insurance?
How much does vtama cream cost?
Why is vtama so expensive?
Vtama cream price without insurance?
Is Vtama a steroid-free cream for psoriasis?