TAPINAROF - Generic Drug Details

What are the generic drug sources for tapinarof and what is the scope of patent protection?

Tapinarof is the generic ingredient in one branded drug marketed by Dermavant Sci and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tapinarof has seventy-two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for TAPINAROF

International Patents:	72
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	13
Patent Applications:	211
What excipients (inactive ingredients) are in TAPINAROF?	TAPINAROF excipients list
DailyMed Link:	TAPINAROF at DailyMed

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

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.

Recent Clinical Trials for TAPINAROF

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 2/Phase 3
Dermavant Sciences, Inc.	Phase 2/Phase 3
Psoriasis Treatment Center of Central New Jersey	Phase 4

See all TAPINAROF clinical trials

Pharmacology for TAPINAROF

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

Anatomical Therapeutic Chemical (ATC) Classes for TAPINAROF

D05AX	Other antipsoriatics for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

US Patents and Regulatory Information for TAPINAROF

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
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes				Y
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes			Y
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes
Dermavant Sci	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes			Y

International Patents for TAPINAROF

Country	Patent Number	Title	Estimated Expiration
Chile	2023000154	Proceso para preparar tapinarof; compuestos intermediarios; solvato de tapinarof; forma cristalina y composición farmacéutica que la comprende (sol. div. 202001226).
China	107666902	局部药物组合物 (TOPICAL PHARMACEUTICAL COMPOSITIONS)
Slovenia	3297605
Japan	7166399
Hungary	E059066

TAPINAROF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tapinarof

Introduction

Tapinarof, a novel aryl hydrocarbon receptor modulating agent, has been making significant waves in the dermatology market, particularly for the treatment of plaque psoriasis and atopic dermatitis. Developed by Dermavant Sciences, this topical cream has faced various challenges but also shows promising potential. Here’s a detailed look at the market dynamics and financial trajectory of tapinarof.

Market Challenges

Competitive Landscape

The psoriasis market is highly competitive, dominated by biologics such as AbbVie’s Humira, Johnson & Johnson’s Remicade, and newer drugs like Skyrizi and Tremfya. This competitive environment poses a significant challenge for any new drug entry, including tapinarof[1].

COVID-19 Impact

The COVID-19 pandemic has added another layer of complexity to the launch of tapinarof. Many drug launches have been impacted by the pandemic, leading to disappointing results even for large biotech and pharma companies. This trend is expected to continue, affecting smaller companies like Dermavant[1].

Historical Topical Launches

Past launches of topical creams for psoriasis have shown mixed results. For example, Bausch Health’s Duobrii generated only $88 million in 2020, and Almirall/MC2’s Wynzora, approved in mid-2020, has yet to report full-year sales. This historical context suggests that tapinarof will need to overcome these precedents to achieve success[1].

Market Opportunities

Safety and Efficacy

Tapinarof's unique selling point lies in its safety profile. Unlike systemic biologics, which can have immune system-related side effects, tapinarof is a topical cream that is generally safer. This could be a significant advantage in a market where safety concerns are paramount[1].

Cosmetically Elegant and Steroid-Free

The cream is once-daily, cosmetically elegant, and steroid-free, making it an attractive option for both acute treatment and long-term management of psoriasis and atopic dermatitis. This profile could help tapinarof stand out in a crowded market[4].

Financial Trajectory

Initial Projections

Analysts at Jefferies initially projected that tapinarof could generate $10 million in revenue in the year of its launch, ramping up to $50 million in 2023 for its psoriasis label. These projections were based on a mid-2022 launch, which has since been realized[1].

Actual Revenue Performance

As of the fiscal year ended March 31, 2023, VTAMA (tapinarof) generated $28 million in net product revenue, with over 170,000 prescriptions written by approximately 11,000 unique prescribers since its launch. This performance indicates a steady start, though it still lags behind initial high-end projections[2].

Funding and Milestones

Dermavant secured significant funding to support the launch and commercialization of tapinarof. A $160 million revenue interest purchase and sale agreement, along with a $40 million senior secured credit facility, were key in financing milestone payments and commercial preparation[5].

International Approvals and Revenue

Tapinarof has received approval in Japan for both psoriasis and atopic dermatitis, with Dermavant set to receive a $28 million milestone payment. This international approval adds to the drug's revenue potential and underscores its global market viability[4].

Future Outlook

FDA Review for Atopic Dermatitis

The FDA has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof's use in atopic dermatitis, with a new target action date of March 12, 2025. If approved, this could significantly boost revenue, with Organon projecting approximately $125 million in revenue contribution for VTAMA in 2025[3].

Commercial Preparation

Dermavant is actively building out its sales team, adding 75 to 100 reps, and focusing on strengthening market access. This strategic effort is aimed at maximizing the drug's commercial potential once it gains additional approvals[1].

Key Takeaways

• Competitive Market: Tapinarof faces a competitive psoriasis market dominated by biologics.
• Safety Advantage: The drug's safety profile, being a topical and steroid-free cream, is a significant advantage.
• Financial Performance: Initial revenue has been steady but below high-end projections.
• International Approvals: Approval in Japan adds to the drug's global revenue potential.
• Future Growth: Potential approval for atopic dermatitis could significantly boost revenue in 2025.

FAQs

Q: What are the main challenges facing the launch of tapinarof? A: The main challenges include a competitive market dominated by biologics, the ongoing impact of the COVID-19 pandemic, and mixed results from past topical cream launches.

Q: What makes tapinarof unique in the market? A: Tapinarof is a once-daily, cosmetically elegant, and steroid-free topical cream with a safer profile compared to systemic biologics.

Q: How has tapinarof performed financially since its launch? A: As of March 31, 2023, VTAMA generated $28 million in net product revenue, with over 170,000 prescriptions written.

Q: What international approvals has tapinarof received? A: Tapinarof has been approved in Japan for both psoriasis and atopic dermatitis.

Q: What is the projected revenue for VTAMA in 2025 if it gains approval for atopic dermatitis? A: Organon projects approximately $125 million in revenue contribution for VTAMA in 2025 if it gains approval for atopic dermatitis.

Sources

1. FiercePharma - Dermavant faces a perfect storm of pressures for tapinarof, but there hope for psoriasis
2. Roivant - Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023
3. Organon - Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis
4. BioSpace - Dermavant Announces Approval of Tapinarof in both Psoriasis and Atopic Dermatitis in Japan
5. Dermavant - Dermavant Announces $200 Million of Financing