AMZEEQ Drug Patent Profile

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

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

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amzeeq

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

Summary for AMZEEQ

International Patents:	25
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	1
Patent Applications:	2,938
Drug Prices:	Drug price information for AMZEEQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMZEEQ
What excipients (inactive ingredients) are in AMZEEQ?	AMZEEQ excipients list
DailyMed Link:	AMZEEQ at DailyMed

See drug prices for AMZEEQ

Recent Clinical Trials for AMZEEQ

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

Sponsor	Phase
Edward Lain, MD	Phase 4
Vyne Therapeutics Inc.	Phase 4

See all AMZEEQ clinical trials

Pharmacology for AMZEEQ

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Paragraph IV (Patent) Challenges for AMZEEQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMZEEQ	Topical Aerosol Foam	minocycline hydrochloride	4%	212379	1	2021-05-11

US Patents and Regulatory Information for AMZEEQ

AMZEEQ is protected by twelve 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	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,137,200
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,213,512		Y
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	9,675,700		Y
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,265,404		Y
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,517,882
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	8,865,139		Y
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,398,641

International Patents for AMZEEQ

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

Country	Patent Number	Title	Estimated Expiration
Canada	2867419
United Kingdom	2474930
Canada	2776366	COMPOSITIONS MOUSSANTES SANS EAU ET SANS SURFACTANT, MOUSSES ET GELS FRIABLES, AINSI QUE LEURS UTILISATIONS (SURFACTANT-FREE WATER-FREE FOAMABLE COMPOSITIONS, BREAKABLE FOAMS AND GELS AND THEIR USES)
Mexico	359879
Israel	218865	תכשירי טטרציקלין לשימוש מקומי (Topical tetracycline compositions)
Mexico	2012003985	COMPOSICIONES TOPICAS TETRACICLINA. (TOPICAL TETRACYCLINE COMPOSITIONS.)
World Intellectual Property Organization (WIPO)	2011064631

AMZEEQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMZEEQ

Introduction to AMZEEQ

AMZEEQ (minocycline) topical foam, 4%, is a groundbreaking dermatological treatment developed by Foamix Pharmaceuticals Ltd. and later acquired by Journey Medical Corporation. It is the first and only topical formulation of minocycline approved by the FDA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and children 9 years and older[1][3][4].

Market Need and Target Audience

Acne is the most common skin condition in the United States, affecting up to 50 million Americans annually, according to the American Academy of Dermatology (AAD). This widespread prevalence creates a significant market demand for effective acne treatments. AMZEEQ addresses this need by offering a topical alternative to oral minocycline, which has been prescribed over 30 million times in the past decade[1].

Unique Selling Points and Competitive Advantage

AMZEEQ leverages Foamix's proprietary Molecule Stabilizing Technology (MST)™ platform, which ensures the stability of minocycline in a foam-based vehicle. This technology allows for the direct delivery of minocycline to the skin, reducing systemic absorption and associated side effects. The product's competitive pricing, with a list price of $485 per 30-gram canister, positions it favorably against other brand leaders in the acne prescription market[4].

Commercial Launch and Marketing Strategy

AMZEEQ was commercially launched on January 13, 2020, and is available in retail, community, and specialty pharmacies nationwide. Foamix implemented a multi-channel marketing plan, including sales force deployment to over 6,000 acne-treating providers, product samples, promotional speaker programs, and digital consumer outreach tactics. These efforts aimed to provide broad awareness and availability of AMZEEQ for physicians and patients[4].

Financial Performance

Since its acquisition by Journey Medical Corporation, AMZEEQ has contributed to the company's revenue stream, although its performance has been mixed.

• Initial Sales: In the third quarter of 2021, AMZEEQ and ZILXI (another topical minocycline product) generated approximately $4 million in net sales in the U.S.[1].
• Recent Trends: In the first quarter of 2024, Journey Medical reported a decrease in net product revenues for AMZEEQ and ZILXI, attributed to lower sales volume. This decline was offset by significant increases in the sales of other products like Qbrexza and Accutane, leading to a 7% year-over-year increase in total revenues[2].

Revenue Projections and Milestones

The acquisition of the AMZEEQ franchise includes potential milestone payments based on annual net sales. For instance, Journey Medical is eligible for one-time payments ranging from $10 million to $50 million as annual net sales reach specific thresholds ($100 million to $500 million) per product[3].

Challenges and Opportunities

Despite its unique advantages, AMZEEQ faces several challenges:

• Market Competition: The acne treatment market is highly competitive, with various established and new treatments vying for market share.
• Pricing and Reimbursement: The product's pricing and reimbursement negotiations with third-party payors can impact its commercial success[4].

However, opportunities exist:

• Expanding Dermatology Portfolio: The acquisition of AMZEEQ has expanded Journey Medical’s dermatology portfolio, allowing the company to leverage its existing infrastructure and sales force to drive growth[1].
• Development Stage Programs: The inclusion of development-stage dermatology programs, such as FCD105, offers potential for future growth and innovation[1].

Research and Development Costs

The development and commercialization of AMZEEQ and other products have contributed to significant research and development costs for Journey Medical. In the first quarter of 2024, these costs surged to $7.9 million, driven by FDA filing fees and milestone payments related to other product candidates like DFD-29[2].

Financial Health and Outlook

Journey Medical's financial health is a mixed bag. While the company reported a net loss of $10.4 million in the first quarter of 2024, it also saw improvements in adjusted EBITDA and a reduction in selling, general, and administrative expenses. The acceptance of the New Drug Application (NDA) for DFD-29, with a PDUFA goal date of November 4, 2024, adds to the company's potential future growth prospects[2].

Key Takeaways

• Market Need: AMZEEQ addresses a significant market need for effective acne treatments.
• Unique Technology: The MST™ platform ensures the stability and efficacy of topical minocycline.
• Financial Performance: Mixed results with initial sales contributions but recent declines.
• Revenue Projections: Potential milestone payments based on sales thresholds.
• Challenges and Opportunities: Market competition, pricing, and reimbursement challenges, but opportunities for growth through expanded dermatology portfolio and development programs.

FAQs

Q: What is AMZEEQ used for? A: AMZEEQ is used for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and children 9 years and older.

Q: What technology does AMZEEQ use? A: AMZEEQ uses Foamix's proprietary Molecule Stabilizing Technology (MST)™ platform to deliver minocycline in a foam-based vehicle.

Q: How much does AMZEEQ cost? A: The list price of AMZEEQ is $485 per 30-gram canister.

Q: Who acquired AMZEEQ? A: Journey Medical Corporation acquired AMZEEQ as part of a franchise from VYNE Therapeutics, Inc.

Q: What are the future growth prospects for AMZEEQ? A: Future growth prospects include potential milestone payments based on sales thresholds and the expansion of Journey Medical’s dermatology portfolio.

Cited Sources

1. Journey Medical Corporation Acquires Two FDA-Approved Topical Minocycline Products and Molecule Stabilizing Technology (MST)™ Franchise from VYNE Therapeutics, Inc. - Fortress Biotech.
2. Journey Medical Corporation Reports First Quarter 2024 Financial Results and Recent Corporate Highlights - Stock Titan.
3. Journey Medical Corporation Acquires Two FDA-Approved Topical Minocycline Products and Molecule Stabilizing Technology (MST)™ Franchise from VYNE Therapeutics, Inc. - Journey Medical Corporation.
4. Foamix Announces AMZEEQ™ (minocycline) Topical Foam Available in Pharmacies Nationwide on January 13th for the Treatment of Moderate to Severe Acne - Biospace.