IMPOYZ Drug Patent Profile

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

Impoyz is a drug marketed by Primus Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in sixteen countries.

The generic ingredient in IMPOYZ is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Impoyz

A generic version of IMPOYZ was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for IMPOYZ

International Patents:	26
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Patent Applications:	4,476
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMPOYZ
What excipients (inactive ingredients) are in IMPOYZ?	IMPOYZ excipients list
DailyMed Link:	IMPOYZ at DailyMed

Pharmacology for IMPOYZ

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for IMPOYZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMPOYZ	Cream	clobetasol propionate	0.025%	209483	1	2019-12-06

US Patents and Regulatory Information for IMPOYZ

IMPOYZ is protected by thirteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	10,064,875		Y
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	9,956,231		Y
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	9,855,334		Y

International Patents for IMPOYZ

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

Country	Patent Number	Title	Estimated Expiration
China	107872972	包含皮质类固醇的外用组合物 (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)
Australia	2016228574	Topical compositions comprising a corticosteroid
Japan	5833007

IMPOYZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IMPOYZ

Introduction to IMPOYZ

IMPOYZ Cream, developed by Encore Dermatology Inc., is a significant addition to the dermatology market. It is the only FDA-approved high-potency topical corticosteroid with 0.025% clobetasol propionate, marking a new era in the treatment of moderate to severe plaque psoriasis[1][4].

Market Need and Demand

Psoriasis is a chronic and challenging condition to treat, significantly impacting patients' quality of life. The launch of IMPOYZ Cream addresses this need by providing dermatologists with a new treatment option that uses a well-known active ingredient, clobetasol propionate, in a lower concentration. This innovation is particularly important as it offers a more tolerable and safe alternative to traditional clobetasol formulations[1][4].

Competitive Landscape

The dermatology market, particularly for psoriasis treatments, is highly competitive. However, IMPOYZ Cream stands out due to its unique formulation and the fact that it is the first new strength of clobetasol propionate available in over 30 years. This differentiation gives Encore Dermatology a competitive edge, positioning the company as a leader in specialty medical dermatology[1][4].

Regulatory Approval and Safety Profile

IMPOYZ Cream has received FDA approval, which is a critical milestone for any pharmaceutical product. The safety profile of IMPOYZ Cream is favorable, although it comes with the usual warnings and precautions associated with topical corticosteroids, such as the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression and systemic effects like Cushing’s syndrome. These risks are managed through careful patient evaluation and treatment adjustments[1].

Financial Impact on Encore Dermatology

The launch of IMPOYZ Cream is a significant financial milestone for Encore Dermatology. It is the first of several New Drug Application (NDA) products the company plans to launch, indicating a strategic shift towards innovative and high-value products. This move is expected to drive revenue growth and enhance the company's market presence in the dermatology sector[1][4].

Revenue Potential

Given the chronic nature of psoriasis and the lack of new treatment options in recent years, IMPOYZ Cream is poised to capture a substantial market share. The product's availability in a 60g tube by prescription only in the U.S. ensures a steady revenue stream. As one of the few specialty medical dermatology companies bringing new products to the market, Encore Dermatology is likely to see increased revenue from IMPOYZ Cream, contributing to the company's overall financial growth[1][4].

Market Expansion and Growth Strategy

Encore Dermatology's strategy involves expanding its product portfolio to include treatments for various dermatological conditions, such as acne and eczema. The success of IMPOYZ Cream is expected to pave the way for future product launches, further solidifying the company's position in the market. This growth strategy is aligned with the company's mission to provide innovative solutions for dermatology providers and their patients[1][4].

Industry Trends and Challenges

The pharmaceutical industry, particularly the dermatology segment, faces several challenges, including regulatory hurdles, pricing pressures, and intense competition. Despite these challenges, companies like Encore Dermatology are focusing on high-value launches and cost control measures to drive margins and growth. The launch of IMPOYZ Cream is a testament to this strategy, highlighting the company's ability to navigate industry challenges and deliver innovative products[2][3].

R&D and Innovation

The development of IMPOYZ Cream underscores Encore Dermatology's commitment to research and development. The company's investment in R&D is crucial for identifying new therapy areas and developing complex and specialty products. This focus on innovation is expected to continue, with IMPOYZ Cream being just the beginning of a series of new product launches aimed at improving patient outcomes and driving business growth[1][4].

Key Takeaways

• Unique Formulation: IMPOYZ Cream is the only FDA-approved high-potency topical corticosteroid with 0.025% clobetasol propionate.
• Market Need: Addresses the chronic and challenging condition of psoriasis with a more tolerable and safe treatment option.
• Competitive Edge: Differentiates Encore Dermatology in the competitive dermatology market.
• Regulatory Approval: FDA-approved with a favorable safety profile.
• Financial Impact: Significant revenue potential and a milestone for Encore Dermatology's growth strategy.
• Market Expansion: Part of a broader strategy to expand the company's product portfolio in dermatology.

FAQs

Q: What is IMPOYZ Cream used for? A: IMPOYZ Cream is used for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older.

Q: What makes IMPOYZ Cream unique? A: IMPOYZ Cream is the only FDA-approved high-potency topical corticosteroid with 0.025% clobetasol propionate, offering a new strength of a well-known active ingredient.

Q: What are the potential side effects of IMPOYZ Cream? A: IMPOYZ Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and other systemic effects, although these are rare.

Q: How is IMPOYZ Cream available? A: IMPOYZ Cream is available in the U.S. by prescription only in a 60g tube.

Q: What is the significance of IMPOYZ Cream for Encore Dermatology? A: The launch of IMPOYZ Cream is a significant milestone for Encore Dermatology, marking the company's entry into launching new and innovative products in the dermatology sector.

Citations

1. Encore Dermatology Inc. Announces the Launch of IMPOYZTM Clobetasol Propionate Cream, 0.025 Percent, a Newly Formulated High-Potency Topical Corticosteroid - Biospace
2. Dr. Reddy's Labs - HDFC securities - HDFC Securities
3. Annual Report - Edelweiss Securities Limited
4. Encore Dermatology Announces the Launch of IMPOYZ - EW Healthcare
5. United States - Dr. Reddy's Laboratories - Dr. Reddy's Laboratories