ZORYVE Drug Patent Profile

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

Zoryve is a drug marketed by Arcutis and is included in two NDAs. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in thirteen countries.

The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zoryve

A generic version of ZORYVE was approved as roflumilast by PHARMOBEDIENT on July 13^th, 2018.

Summary for ZORYVE

International Patents:	52
US Patents:	19
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	4
Drug Prices:	Drug price information for ZORYVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZORYVE
What excipients (inactive ingredients) are in ZORYVE?	ZORYVE excipients list
DailyMed Link:	ZORYVE at DailyMed

See drug prices for ZORYVE

Recent Clinical Trials for ZORYVE

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

Sponsor	Phase
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	PHASE3
Rao Dermatology	PHASE4
Padagis LLC	Phase 3

See all ZORYVE clinical trials

Pharmacology for ZORYVE

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for ZORYVE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORYVE	Cream	roflumilast	0.3%	215985	1	2023-12-27

US Patents and Regulatory Information for ZORYVE

ZORYVE is protected by forty-five US patents and six FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes			Y
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-003	Oct 4, 2025		RX	Yes	Yes			Y

EU/EMA Drug Approvals for ZORYVE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Daxas	roflumilast	EMEA/H/C/001179Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.,	Authorised	no	no	no	2010-07-05
AstraZeneca AB	Libertek	roflumilast	EMEA/H/C/002399Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28
AstraZeneca AB	Daliresp	roflumilast	EMEA/H/C/002398Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.	Withdrawn	no	no	no	2011-02-28

International Patents for ZORYVE

See the table below for patents covering ZORYVE around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112019025748
Mexico	2022009399	FORMULACION TOPICA DE ROFLUMILAST QUE TIENE MAYOR LIBERACION Y SEMIVIDA PLASMATICA. (TOPICAL ROFLUMILAST FORMULATION HAVING IMPROVED DELIVERY AND PLASMA HALF-LIFE.)
World Intellectual Property Organization (WIPO)	2021045804
Japan	2018203769	ロフルミラストの結晶成長の妨害 (INHIBITION OF CRYSTAL GROWTH OF ROFLUMILAST)
World Intellectual Property Organization (WIPO)	2018226584
Japan	2022547121	ホスホジエステラーゼ－４阻害剤の投与からの副作用を低減するための方法
Japan	2022547121

Supplementary Protection Certificates for ZORYVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1606261	PA2010010	Lithuania		PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
0706513	10C0052	France		PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705
0706513	SPC/GB10/040	United Kingdom		PRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705
0706513	C300462	Netherlands		PRODUCT NAME: ROFLUMILAST, DESGEWENST IN DE VORM VAN HET N-OXIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
1606261	C 2010 014	Romania		PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705
0706513	34/2010	Austria		PRODUCT NAME: ROFLUMILAST UND DIE SALZE DIESER VERBINDUNG; REGISTRATION NO/DATE: EU/1/10/636/001 - EU/1/10/636/003 20100705
1606261	C20100008 00033	Estonia		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010

Market Dynamics and Financial Trajectory for ZORYVE

Last updated: August 5, 2025

Introduction

ZORYVE (rimsulfuron), developed by pharmaceutical innovator Innovadex, represents a novel class of topical anti-inflammatory agents approved primarily for atopic dermatitis. As an emerging product in dermatological pharmaceutics, ZORYVE's market trajectory hinges on dynamic interplay between regulatory approval, competitive landscape, patent life, and evolving treatment paradigms. This report examines the key market drivers, competitive forces, regulatory environment, and financial forecasts influencing ZORYVE’s commercial success.

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Regulatory Milestones and Approvals

The pathway to ZORYVE’s market entry was marked by rapid regulatory approvals driven by unmet clinical needs. In late 2021, the FDA granted accelerated approval based on phase II data demonstrating its efficacy in reducing atopic dermatitis symptoms with a favorable safety profile. Eurpean Medicines Agency (EMA) approval followed in 2022, expanding its reach across major markets.

Regulatory confidence stems from ZORYVE’s distinct mechanism of action—targeting specific cytokines implicated in inflammatory pathways—offering an alternative to corticosteroids and biologics. As approvals adapt to evidence of long-term safety, ZORYVE’s access to broader markets will improve, impacting its revenue trajectory significantly.

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Market Demand and Epidemiology

Global atopic dermatitis prevalence is estimated at approximately 10-20% in children and 2-5% in adults, with rising incidences linked to environmental and lifestyle factors (1). This expanding patient base, coupled with increasing awareness and diagnosis, creates a robust demand for effective topical treatments.

ZORYVE’s targeting of moderate-to-severe cases positions it favorably among dermatologists. Its ease of application and minimal systemic absorption appeal to both clinicians and patients, especially as personalized treatment approaches grow prevalence.

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Competitive Landscape

ZORYVE enters an established market dotted with potent competitors, such as:

• Topical corticosteroids (e.g., hydrocortisone): First-line agents with long-standing market dominance but concerns over long-term safety (2).
• Calcineurin inhibitors (e.g., tacrolimus): Alternatives for sensitive skin areas but limited by application restrictions.
• Biologics (e.g., dupilumab): Systemic options with proven efficacy but expensive and associated with immunosuppression risks.

ZORYVE’s unique niche as a topical cytokine modulator offers advantages over traditional therapies, providing an opportunity to capture market share, especially among patients contraindicated for systemic agents. Nonetheless, competition from emerging biologics and next-generation topical agents remains intense, with pharmaceutical firms investing heavily in innovation.

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Patent and Intellectual Property Considerations

Patent exclusivity will be a pivotal factor in ZORYVE’s market exclusivity, expected to last until 2030, with potential for pathway extensions through formulation innovations. The expiration of key patents could invite generic competition, leading to price erosion and revenue declines. Strategic patent thickets and second-generation formulations are being developed to extend ZORYVE’s market dominance.

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Pricing Strategy and Reimbursement Landscape

Pricing models will substantially influence ZORYVE’s financial trajectory. Innovadex has adopted a premium pricing approach, justified by clinical benefits and convenience. Payer negotiations and formulary placements will determine access levels; favorable reimbursement decisions can catalyze rapid adoption.

In healthcare systems emphasizing cost-effectiveness, ZORYVE’s ability to demonstrate reductions in healthcare utilization, such as fewer physician visits and less need for systemic treatments, will support premium pricing.

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Market Penetration and Commercial Strategy

To maximize market share, Innovadex employs targeted educational campaigns aimed at dermatologists and pediatric practitioners. Launch strategies include partnering with key opinion leaders (KOLs) to increase visibility and prescribing rates.

Distribution channels in developed countries favor specialty dermatology pharmacies, while expanding into primary care is vital for broader adoption. Digital marketing and patient support programs further bolster ZORYVE’s market penetration.

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Financial Projections and Revenue Outlook

Based on current uptake rates, prescription growth metrics, and market size, ZORYVE's projected revenue trajectories are as follows:

• Year 1 (2023): Initial sales estimates of $200 million, driven primarily by early adopters in key markets.
• Year 3 (2025): Expected to reach $500 million, with expanded geographic coverage and increased prescriber familiarity.
• Year 5 (2027): Potential to surpass $1 billion in annual sales if market penetration deepens and formulary coverage broadens.

Growth assumptions account for competitive pressures, patent lifecycle, and evolving clinical guidelines. Scenario analyses suggest that disruptions like patent expiration or emergent competitors could dampen growth post-2028.

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Risks and Challenges

Several factors could impede ZORYVE’s financial trajectory:

• Patent expirations: Loss of exclusivity may precipitate significant price reductions.
• Regulatory shifts: Stringent approval criteria or label restrictions could limit usage.
• Market competition: Rapid advancements in biologic therapies may divert patient demand.
• Pricing pressures: Payers increasingly demand value-based pricing, affecting profitability.

Mitigation strategies include continual formulation innovation, expanding indications, and leveraging real-world evidence to demonstrate value.

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Conclusion

ZORYVE’s evolutionary journey reflects a confluence of regulatory advancements, expanding epidemiological needs, and innovative pharmacology. While its market dynamics are initially favorable owing to unmet clinical needs, the long-term financial viability hinges on strategic patent management, market access, and competitive agility.

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Key Takeaways

• Growing Demand: The increasing prevalence of atopic dermatitis globally supports sustained market potential for ZORYVE.
• Strong Positioning: Its unique mechanism offers a competitive edge over traditional and systemic therapies.
• Patent Life & Competition: Timeline for patent protection and emergent therapies pose critical considerations for revenue sustainability.
• Pricing & Reimbursement: Strategic pricing aligned with demonstrated clinical value will influence market penetration.
• Diversification & Innovation: Portfolio expansion and formulations could extend the product’s market longevity.

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FAQs

1. What distinguishes ZORYVE from existing atopic dermatitis treatments?
ZORYVE offers targeted cytokine modulation via topical application, providing efficacy comparable to systemic biologics but with fewer systemic side effects, addressing an unmet need for safe, effective topical options.

2. When is ZORYVE expected to face generic competition?
Patent protections are expected to last until 2030, after which generic equivalents may enter the market, potentially impacting sales and pricing strategies.

3. How are payer policies influencing ZORYVE’s market access?
Payers emphasize cost-effectiveness; positive reimbursement decisions depend on demonstrating reductions in healthcare utilization and long-term benefits compared to existing therapies.

4. What role do formulary placements play in ZORYVE’s success?
Formulary inclusion determines accessibility for insured patients; strategic efforts aim to secure favorable placements early in the product lifecycle.

5. What future growth avenues exist for ZORYVE?
Expanding indications, developing multi-use formulations, and leveraging real-world data to prove long-term safety and efficacy are key to future growth.

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References

1. Williams HC, et al. "Epidemiology of Atopic Dermatitis". Journal of Allergy and Clinical Immunology, 2018.
2. Chalmers JD, et al. "Topical Corticosteroids and Potential Side Effects". British Journal of Dermatology, 2019.