ZILXI Drug Patent Profile

When do Zilxi patents expire, and what generic alternatives are available?

Zilxi is a drug marketed by Journey and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in ten countries.

The generic ingredient in ZILXI is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zilxi

A generic version of ZILXI was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for ZILXI

International Patents:	22
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Patent Applications:	2,938
Drug Prices:	Drug price information for ZILXI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZILXI
What excipients (inactive ingredients) are in ZILXI?	ZILXI excipients list
DailyMed Link:	ZILXI at DailyMed

See drug prices for ZILXI

Pharmacology for ZILXI

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Paragraph IV (Patent) Challenges for ZILXI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZILXI	Topical Aerosol Foam	minocycline hydrochloride	1.50%	213690	1	2022-02-28

US Patents and Regulatory Information for ZILXI

ZILXI is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	10,213,512		Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	12,138,311
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	8,865,139		Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	10,265,404		Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	8,992,896		Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	9,675,700		Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes	10,946,101

International Patents for ZILXI

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

Country	Patent Number	Title	Estimated Expiration
Canada	2867419	UTILISATION DE COMPOSITIONS DE TETRACYCLINE POUR LE TRAITEMENT DES BLESSURES ET LA RESTAURATION DE LA PEAU (USE OF TETRACYCLINE COMPOSITIONS FOR WOUND TREATMENT AND SKIN RESTORATION)
World Intellectual Property Organization (WIPO)	2011064631
Mexico	359879	COMPOSICIONES TÓPICAS DE TETRACICLINA. (TOPICAL TETRACYCLINE COMPOSITIONS.)
Canada	2776474	COMPOSITIONS DE TETRACYCLINE A USAGE TOPIQUE (TOPICAL TETRACYCLINE COMPOSITIONS)
Canada	2776471	COMPOSITIONS MOUSSANTES DEPOURVUES D'AGENT TENSIOACTIF ET D'EAU ET MOUSSES CASSABLES ET LEURS UTILISATIONS (SURFACTANT-FREE, WATER-FREE, FOAMABLE COMPOSITIONS AND BREAKABLE FOAMS AND THEIR USES)
World Intellectual Property Organization (WIPO)	2011138678
World Intellectual Property Organization (WIPO)	2011039638

Market Dynamics and Financial Trajectory for Zilxi

Introduction to Zilxi

Zilxi, a topical minocycline foam, is a prescription medication developed and marketed by Journey Medical Corporation. It is primarily used for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea (PPR).

Market Context

Global Topical Drugs Market

The global topical drugs market is experiencing significant growth, projected to surpass USD 217.9 billion by 2030, with a CAGR of 9.35% from 2022 to 2030. This growth is driven by advancements in technology, increased health awareness, and the rising demand for topical treatments[4].

Dermal Drug Delivery Segment

The dermal drug delivery segment, which includes products like Zilxi, dominated the industry in 2021, accounting for more than 53.8% of the global revenue. This segment is expected to continue its dominance due to the efficacy and convenience of topical treatments for dermatological conditions[4].

Financial Performance of Zilxi

Revenue Contribution

Zilxi, along with other core products like Qbrexza, Accutane, and Amzeeq, contributes significantly to Journey Medical Corporation's revenue. In the second quarter of 2023, these core products accounted for approximately 92% of the Company's total net product revenue, amounting to $15.6 million[1].

Quarterly and Annual Revenue Trends

• In the second quarter of 2023, Journey Medical reported total net revenues of $17.2 million, with a notable increase in net product revenues from its core products, including Zilxi. However, this was partially offset by a decrease in revenues from legacy products like Targadox due to generic competition[1].
• For the full year 2022, the Company generated record total revenues of $73.7 million, a 17% increase from 2021. This growth was driven by the performance of its core products, including Zilxi[2].

Recent Quarterly Performance

In the first quarter of 2024, Journey Medical reported a 7% year-over-year revenue growth, driven primarily by increased sales of Qbrexza and Accutane. However, there was a decrease in net product revenues from Amzeeq and Zilxi due to lower sales volumes. This decline was also influenced by the discontinuation of Ximino and ongoing generic competition affecting Targadox[5].

Cost and Expense Dynamics

Cost of Goods Sold

The cost of goods sold for Journey Medical increased slightly in the first quarter of 2024 to $6.8 million, reflecting the increase in net product revenues, including those from Zilxi[5].

Research and Development Expenses

Research and development expenses for Journey Medical have fluctuated, particularly with the conclusion of Phase 3 clinical trials for DFD-29, another product in the pipeline. However, in the first quarter of 2024, R&D expenses increased due to a filing fee payment to the FDA for DFD-29 and a contractual milestone payment to Dr. Reddy’s Laboratories. This increase did not directly impact Zilxi but reflects the broader R&D activities of the Company[5].

Selling, General, and Administrative Expenses

Journey Medical has been implementing cost reduction initiatives, which resulted in a significant decrease in selling, general, and administrative expenses in the first quarter of 2024. This reduction is expected to continue and positively impact the financial trajectory of products like Zilxi[5].

Competitive Landscape

Generic Competition

One of the significant challenges facing Zilxi and other Journey Medical products is generic competition. For instance, Targadox has experienced erosion due to generic competition, which has impacted overall revenue. However, focused sales and marketing efforts on core products like Zilxi have helped mitigate some of these effects[1][5].

Market Position

Journey Medical's strategic acquisitions and partnerships, such as the agreement with Vyne Therapeutics to acquire the Molecular Stabilizing Technology franchise, which includes Zilxi, have strengthened its market position. These moves have enhanced the Company's portfolio and capabilities in the topical drug market[4].

Future Outlook

Growth Prospects

Given the growing demand for topical treatments and the Company's focused marketing efforts, Zilxi is expected to continue contributing to Journey Medical's revenue growth. The global topical drugs market's projected CAGR of 9.35% from 2022 to 2030 bodes well for products like Zilxi[4].

Regulatory and Development Milestones

The successful completion of clinical trials and regulatory approvals for other products in Journey Medical's pipeline, such as DFD-29, could also positively impact the Company's overall financial health and market position, indirectly benefiting Zilxi[1][5].

Key Takeaways

• Market Growth: The global topical drugs market is expanding, driven by technological advancements and increasing health awareness.
• Revenue Contribution: Zilxi is a significant contributor to Journey Medical's revenue, particularly among its core products.
• Cost Dynamics: The Company is managing costs through reduction initiatives, which should benefit Zilxi's financial performance.
• Competitive Landscape: Generic competition remains a challenge, but focused marketing efforts are helping to maintain market share.
• Future Outlook: Zilxi is poised for continued growth within the expanding topical drugs market.

FAQs

1. What is Zilxi used for? Zilxi is a topical minocycline foam used for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea (PPR).

2. How has Zilxi performed in recent quarters? In the first quarter of 2024, Zilxi experienced a decrease in net product revenues due to lower sales volumes, although the Company's overall revenue grew driven by other core products.

3. What are the key challenges facing Zilxi? One of the main challenges is generic competition affecting other Journey Medical products, although focused marketing efforts have helped mitigate this impact for Zilxi.

4. How does Zilxi fit into Journey Medical's product portfolio? Zilxi is one of the Company's core products, along with Qbrexza, Accutane, and Amzeeq, and contributes significantly to the Company's revenue.

5. What is the outlook for Zilxi in the future? Given the growing demand for topical treatments and Journey Medical's strategic marketing efforts, Zilxi is expected to continue contributing to the Company's revenue growth.

Sources

1. Journey Medical Corporation Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights https://www.fortressbiotech.com/investors/news-events/press-releases/detail/560/journey-medical-corporation-reports-second-quarter-2023

2. Journey Medical Corporation Reports Full-Year 2022 Financial Results https://www.fortressbiotech.com/news-media/press-releases/detail/520/journey-medical-corporation-reports-full-year-2022

3. Form 10-K for Tarsus Pharmaceuticals INC filed 02/27/2024 https://ir.tarsusrx.com/static-files/b07b28e9-c0dd-4ef4-b5f7-47e0592cd43d

4. Topical Drugs Market Size to Surpass USD 217.9 Billion by 2030 https://www.biospace.com/topical-drugs-market-size-to-surpass-usd-217-9-billion-by-2030

5. Journey Medical Corporation Reports First Quarter 2024 Financial Results https://ir.journeymedicalcorp.com/new-events/press-releases/detail/66/journey-medical-corporation-reports-first-quarter-2024

Last updated: 2024-12-17