ZORYVE Drug Patent Profile

Which patents cover Zoryve, and what generic alternatives are available?

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

This drug has forty-eight patent family members in thirteen countries.

The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Fourteen 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 MYLAN on July 13^th, 2018.

Summary for ZORYVE

International Patents:	48
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	1
Patent Applications:	5,558
Drug Prices:	Drug price information 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
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 twenty-five US patents and four 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	10,940,142		Y
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes	11,129,818
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes
Arcutis	ZORYVE	roflumilast	FOAM;TOPICAL	217242-001	Dec 15, 2023		RX	Yes	Yes	9,907,788
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985-001	Jul 29, 2022		RX	Yes	Yes

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/001179 Daxas 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/002399 Libertek 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/002398 Daliresp 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
China	112263577	罗氟司特晶体生长的抑制 (Inhibition of roflumilast crystal growth)
Australia	2021214399	Topical roflumilast formulation having improved delivery and plasma half-life
Mexico	2022013151	INHIBICION DEL CRECIMIENTO DE CRISTALES DE ROFLUMILAST. (INHIBITION OF CRYSTAL GROWTH OF ROFLUMILAST.)
Spain	2975278
Eurasian Patent Organization	039942	ИНГИБИРОВАНИЕ РОСТА КРИСТАЛЛА РОФЛУМИЛАСТА (INHIBITION OF GROWTH OF ROFLUMILAST CRYSTAL)

Supplementary Protection Certificates for ZORYVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0706513	1090034-8	Sweden		PRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 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
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	C20100008 00033	Estonia		PRODUCT NAME: DAXAS-ROFLUMILAST; REG NO/DATE: K(2010)4785 05.07.2010
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

ZORYVE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZORYVE

Introduction to ZORYVE

ZORYVE, developed by Arcutis Biotherapeutics, is a significant player in the treatment of atopic dermatitis and other skin conditions. The drug, available in cream and foam formulations, has garnered substantial attention due to its steroid-free composition and promising clinical outcomes.

FDA Approvals and Indications

ZORYVE has received FDA approval for treating mild to moderate atopic dermatitis in both adults and children. This approval is Arcutis' third FDA approval in two years, highlighting the company's robust pipeline and strong R&D capabilities[3].

Market Positioning

ZORYVE's unique selling proposition lies in its steroid-free formulation, addressing concerns over long-term steroid use. This differentiation enables Arcutis to capture market share from existing atopic dermatitis treatments, particularly among patients seeking alternatives to steroids[3].

Revenue Growth and Financial Performance

Q1 2024 Financials

In the first quarter of 2024, ZORYVE cream 0.3% generated $15 million in sales, marking a 675% growth compared to the same quarter in the previous year. Additionally, revenue from ZORYVE topical foam 0.3% reached $6.5 million, showing a sequential increase of 59%[1].

Q2 2024 Financials

The second quarter saw net product revenues for the ZORYVE franchise increase to $30.9 million, representing a 547% year-over-year growth and a 43% quarter-over-quarter increase. This robust growth was driven by strong unit demand and improvements in gross-to-net (GTN) margins, which are now in the high 50% range[2][4].

Q3 2024 Financials

In the third quarter of 2024, net product revenues for the ZORYVE franchise continued to rise, reaching $44.8 million. This included $22.0 million for ZORYVE cream 0.3% and $20.3 million for ZORYVE foam 0.3%. The year-over-year increase was attributed to strong sales and marketing efforts related to the launches of ZORYVE cream and foam[5].

Competitive Landscape

The atopic dermatitis treatment market is highly competitive, with emerging therapies presenting significant challenges to ZORYVE. These novel treatments bring innovative mechanisms of action and promising clinical outcomes, potentially reshaping treatment paradigms and patient outcomes. To maintain its market position, Arcutis must adapt strategically to these competitive pressures[1].

Co-Promotion and Market Expansion

Arcutis has entered a co-promotion agreement with Kowa Pharmaceuticals to expand ZORYVE's reach in primary care and pediatric offices. This partnership aims to address millions of patients treated outside of dermatology offices, further expanding the total addressable market for ZORYVE[2][4].

Regulatory and Development Milestones

Arcutis has submitted a supplemental New Drug Application (sNDA) for ZORYVE foam for the treatment of scalp and body psoriasis. If approved, this new indication could significantly enhance revenue opportunities for the ZORYVE franchise. Additionally, the company is assessing roflumilast cream for atopic dermatitis in children aged two to five years at a reduced concentration of 0.05%[1][2].

Financial Flexibility and Cash Position

Despite strong sales growth, Arcutis reported a net loss of $52.3 million in Q2 2024 and $41.5 million in Q3 2024. However, the company has improved its financial flexibility by amending its $200 million term-loan and making a partial prepayment of $100 million of the outstanding debt. As of September 30, 2024, Arcutis had $331.2 million in cash, cash equivalents, restricted cash, and marketable securities[2][5].

Operational Expenses

The company has seen an increase in selling, general, and administrative (SG&A) expenses, primarily due to sales and marketing efforts related to the launches of ZORYVE cream and foam. In Q3 2024, SG&A expenses were $58.8 million, up from $47.6 million in the corresponding period in 2023[5].

Future Outlook

The long-term success of ZORYVE will depend on commercial execution, payer acceptance, and patient adoption. The recent FDA approvals and the co-promotion agreement with Kowa Pharmaceuticals position Arcutis well for further growth. However, the company must continue to navigate the competitive landscape and adapt to emerging therapies to maintain its market share.

"In the second quarter, sales grew by a robust 43% sequentially, highlighting the strength of physician demand for ZORYVE across multiple approved indications, and our ability to continue to improve our GTN," said Frank Watanabe, president and chief executive officer[4].

Key Takeaways

• Robust Revenue Growth: ZORYVE has shown significant revenue growth, with a 547% year-over-year increase in Q2 2024.
• Improved GTN Margins: Gross-to-net margins have improved to the high 50% range.
• Competitive Landscape: The market is competitive, with emerging therapies posing challenges to ZORYVE.
• Co-Promotion Agreement: The agreement with Kowa Pharmaceuticals aims to expand ZORYVE's market reach.
• Regulatory Milestones: sNDA submissions for new indications could enhance revenue opportunities.
• Financial Flexibility: Arcutis has improved its financial flexibility through loan amendments and debt prepayments.

FAQs

What is ZORYVE used for?

ZORYVE is used for treating mild to moderate atopic dermatitis in both adults and children. It is also being developed for treating scalp and body psoriasis.

How has ZORYVE performed financially in 2024?

ZORYVE has shown robust financial performance in 2024, with net product revenues increasing by 547% year-over-year in Q2 2024 and reaching $44.8 million in Q3 2024.

What is unique about ZORYVE's formulation?

ZORYVE's unique selling proposition is its steroid-free formulation, addressing concerns over long-term steroid use.

What is the competitive landscape for ZORYVE?

The atopic dermatitis treatment market is highly competitive, with emerging therapies presenting significant challenges to ZORYVE due to their innovative mechanisms of action and promising clinical outcomes.

What steps is Arcutis taking to expand ZORYVE's market reach?

Arcutis has entered a co-promotion agreement with Kowa Pharmaceuticals to expand ZORYVE's reach in primary care and pediatric offices, and has submitted an sNDA for ZORYVE foam for scalp and body psoriasis treatment.

Sources

1. DelveInsight: "Is ZORYVE the Game-Changer in Atopic Dermatitis Treatment?"
2. StockTitan: "Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update"
3. StockTitan: "FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis"
4. Arcutis: "Arcutis Announces Second Quarter 2024 Financial Results and Provides Business Update"
5. Arcutis: "Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update"