VTAMA Drug Patent Profile

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

Vtama is a drug marketed by Dermavant Sci and is included in one NDA. There are eleven patents protecting this drug.

This drug has seventy-seven 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 will be eligible for patent challenges on May 23, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	77
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	97
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 thirteen 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
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	11,590,088
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	11,622,945		Y
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	10,647,649			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
Lithuania	3297605
Taiwan	I705831
Australia	2018365241

Market Dynamics and Financial Trajectory for VTAMA

Introduction

VTAMA, or tapinarof cream, is a novel topical treatment developed by Dermavant, a subsidiary of Roivant Sciences. Approved by the FDA in May 2022 for the treatment of plaque psoriasis, VTAMA has been touted as a potential blockbuster due to its unique mechanism of action and the significant market need for effective treatments for autoimmune skin conditions.

Approval and Current Indications

VTAMA is the first topical novel chemical entity launched for plaque psoriasis in 25 years. It has received FDA approval for this indication and is currently available across the US, supported by a robust patient support program and a commercial organization targeting 4 million potential annual topical psoriasis prescriptions[3].

Market Performance

Despite its promising clinical profile, VTAMA's market performance has been underwhelming. In the latest quarterly report, VTAMA sales were $18.4 million, a 10% sequential increase from the previous quarter but 24% short of analyst consensus of $24 million. This has led analysts to revise their sales projections significantly, from $1.4 billion to $407 million by 2032[1].

Challenges in Market Adoption

Several factors contribute to VTAMA's slow market uptake:

• Competition from Generic Topical Steroids: Physicians and patients are largely comfortable with generic topical steroids, which are well-established and often cheaper.
• Branded Competition: VTAMA faces competition from other branded treatments, making it challenging to gain significant market share.
• Coverage Concerns: Prescribers have voiced concerns about coverage, particularly at larger pharmacies, creating a perception gap that the company is working to address[1].

Financial Projections and Adjustments

Given the slower-than-expected growth, Leerink Partners have adjusted their financial projections for VTAMA:

• 2024 Sales Estimate: Reduced from $99 million to $75 million.
• 2025 Sales Estimate: Reduced from $201 million to $102 million.
• Long-term Projections: The 2032 sales estimate was slashed from $1.4 billion to $407 million[1].

Future Growth Opportunities

Despite current challenges, there are several avenues that could drive future growth for VTAMA:

Expansion to Atopic Dermatitis

VTAMA is undergoing regulatory review for the treatment of atopic dermatitis (eczema) in adults and children aged 2 and older. Promising data from two phase 3 trials showing immediate and long-term relief from pruritis, a prevalent symptom of eczema, suggest significant potential in this larger market. The FDA review process has been extended due to additional data requests, with a PDUFA date of March 12, 2025[4].

Market Size and Potential

The atopic dermatitis market is approximately four times the size of the psoriasis market, offering a substantial expansion opportunity. Approval in this indication could significantly boost VTAMA's revenue, with projected contributions of around $125 million for the full year 2025[2][4].

Financial Impact and Company Strategy

The financial performance of VTAMA will have several implications for Roivant Sciences:

Revenue Contribution

The expected revenue contribution from VTAMA in 2025 is approximately $125 million, which, although lower than initial projections, still represents a significant addition to Roivant's revenue stream[2][4].

Adjusted EBITDA Margin

The transaction related to VTAMA's approval for atopic dermatitis is expected to result in an approximate 75 basis point headwind to Adjusted EBITDA margin in 2025[2][4].

Capital Allocation and M&A

Roivant Sciences has a strong financial position, with $2.1 billion in cash and a projected cash runway of over two years. This financial strength allows the company to aggressively advance its existing programs and consider new opportunities, including potential M&A activities. The recent $7.1 billion sale of Televant to Roche will add $5.2 billion to Roivant’s coffers, providing further firepower for strategic moves[1][3].

Industry and Market Context

Patient Demand and Payer Progress

Despite the slow growth, patient demand for VTAMA has been impressive, with a near doubling of revenue in recent quarters. However, the net yield from prescriptions has been limited, reflecting ongoing challenges in securing comprehensive coverage[5].

Competitive Landscape

VTAMA competes in a crowded market with both generic and branded treatments. Its unique mechanism of action and non-steroidal, non-systemic profile are key differentiators, but these advantages must be effectively communicated to prescribers and patients to drive adoption[1].

Key Takeaways

• Slow Market Uptake: VTAMA's sales have been below expectations due to competition and coverage issues.
• Future Growth Potential: Approval for atopic dermatitis could significantly boost revenue.
• Financial Adjustments: Revised sales projections reflect current market challenges.
• Strong Financial Position: Roivant Sciences has the financial strength to support VTAMA's launch and explore new opportunities.
• Market Expansion: The atopic dermatitis market offers a larger potential market for VTAMA.

FAQs

Q: What is VTAMA, and what is it used for?

VTAMA, or tapinarof cream, is a topical treatment approved for the treatment of plaque psoriasis and is under review for atopic dermatitis (eczema).

Q: Why is VTAMA's market performance underwhelming?

VTAMA faces competition from generic topical steroids and other branded treatments, and there are concerns about coverage, particularly at larger pharmacies.

Q: What are the financial projections for VTAMA?

Analysts have revised their sales projections significantly, from $1.4 billion to $407 million by 2032, due to slower-than-expected growth.

Q: What is the potential impact of VTAMA's approval for atopic dermatitis?

Approval for atopic dermatitis could significantly boost VTAMA's revenue, with projected contributions of around $125 million for the full year 2025.

Q: How does Roivant Sciences plan to address the challenges facing VTAMA?

Roivant is working to close the perception gap regarding coverage and will experiment with demand-generating tools to enhance market adoption.

Sources

1. FiercePharma: Stagnant sales for Dermavant's Vtama cast doubt on its blockbuster potential.
2. BioSpace: Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis.
3. Roivant Sciences Investor Relations: Roivant Sciences Reports Financial Results for the Fourth Quarter and Full Year.
4. Organon: Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis.
5. Roivant Sciences Investor Relations: February 13, 2023 Financial Results and Business Update for the Quarter Ended December 31, 2022.