RHOFADE Drug Patent Profile

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

Rhofade is a drug marketed by Mayne Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Rhofade

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RHOFADE

International Patents:	24
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	4
Patent Applications:	1,937
Drug Prices:	Drug price information for RHOFADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RHOFADE
What excipients (inactive ingredients) are in RHOFADE?	RHOFADE excipients list
DailyMed Link:	RHOFADE at DailyMed

See drug prices for RHOFADE

Recent Clinical Trials for RHOFADE

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

Sponsor	Phase
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Candela Corporation	Phase 4

See all RHOFADE clinical trials

Pharmacology for RHOFADE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Paragraph IV (Patent) Challenges for RHOFADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RHOFADE	Topical Cream	oxymetazoline hydrochloride	1%	208552	1	2019-06-20

US Patents and Regulatory Information for RHOFADE

RHOFADE is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes			Y
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes

Expired US Patents for RHOFADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017

International Patents for RHOFADE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2951725
New Zealand	727233
European Patent Office	2645993	COMPOSITIONS DE CRÈME PHARMACEUTIQUE CONTENANT DE L'OXYMETAZOLINE (PHARMACEUTICAL CREAM COMPOSITIONS COMPRISING OXYMETAZOLINE)
Japan	2014505026
European Patent Office	3154517	FORMULATIONS D'OXYMÉTAZOLINE STABILISÉES ET LEURS UTILISATIONS (STABILIZED OXYMETAZOLINE FORMULATIONS AND THEIR USES)
World Intellectual Property Organization (WIPO)	2012075319
Australia	2015274532	Stabilized oxymetazoline formulations and their uses

RHOFADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RHOFADE

Introduction

RHOFADE (oxymetazoline hydrochloride) is a topical cream approved by the FDA for the treatment of persistent facial erythema associated with rosacea in adults. Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Market Context: Rosacea Treatment

The global rosacea treatment market is projected to grow steadily, driven by the increasing prevalence of rosacea worldwide. This market was valued at US$ 1.91 billion in 2023 and is expected to reach US$ 2.96 billion by 2030, growing at a CAGR of 6.5% during the forecast period[1].

Product Overview: RHOFADE

RHOFADE is the first and only alpha1A adrenoceptor agonist approved for the treatment of persistent facial erythema associated with rosacea. It was approved by the FDA in January 2017 and has been commercially available since May 2017[4].

Mechanism and Efficacy

RHOFADE works by reducing blood vessel dilation, thereby decreasing facial redness. Clinical trials have shown that a once-daily application of RHOFADE can reduce persistent facial erythema for up to 12 hours. The primary efficacy endpoint in these trials was met, with a significant proportion of patients achieving a 2-grade reduction in erythema compared to the vehicle group[4].

Safety and Precautions

While effective, RHOFADE must be used with caution in patients with certain cardiovascular conditions, such as severe or unstable cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension. It can also potentiate vascular insufficiency and has a risk of angle closure glaucoma[3].

Market Performance of RHOFADE

Sales and Revenue

In the first quarter of 2023, RHOFADE generated net product revenues of $2.411 million, a significant increase from $718,000 in the first quarter of 2022. Despite a decline in the total number of units sold due to a manufacturing delay, the product saw a rebound in sales activity after the issue was resolved[2][5].

Prescription Growth

RHOFADE experienced an 11% growth in prescriptions in the first quarter of 2023 compared to the same period in 2022. This growth is attributed to increased adoption among the dermatology community and effective marketing initiatives[2].

Financial Trajectory

Revenue Streams

The revenue from RHOFADE includes net product revenues, license and collaboration revenues, and government research contracts and grants. For the first quarter of 2023, total revenue from RHOFADE was $3.166 million, up from $1.928 million in the first quarter of 2022[5].

Operating Expenses

Despite the revenue growth, Novan, the company behind RHOFADE, incurred significant operating expenses. For the first quarter of 2023, operating expenses totaled $16.999 million, including costs of goods sold, research and development, selling, general and administrative expenses, and amortization of intangible assets. This resulted in an operating loss of $13.833 million[5].

Cash and Liquidity

As of March 31, 2023, Novan had cash and cash equivalents of $12.541 million. The company believes this, combined with expected product sales, will provide sufficient liquidity to fund its operating needs into the late second quarter of 2023[5].

Market Drivers and Opportunities

Increasing Prevalence of Rosacea

The growing prevalence of rosacea globally is a key driver for the market. The National Rosacea Society estimates that approximately 16 million Americans are affected by rosacea, providing a substantial patient base for RHOFADE[4].

Regional Growth

North America currently dominates the rosacea treatment market due to high awareness levels and an established healthcare infrastructure. However, the Asia Pacific region is expected to witness the fastest growth due to an increasing population suffering from rosacea and improving access to diagnosis and treatment in countries like India and China[1].

Challenges and Restraints

Manufacturing Delays

Manufacturing delays, such as the one experienced in the first quarter of 2023, can impact sales and revenue. These delays can lead to back-orders and temporarily affect the product's market performance[2].

Competitive Landscape

The rosacea treatment market is competitive, with various drug classes including antibiotics, retinoids, corticosteroids, and immunosuppressants. RHOFADE must compete with these existing treatments to maintain market share[1].

Key Takeaways

• Market Growth: The global rosacea treatment market is expected to grow at a CAGR of 6.5% from 2023 to 2030.
• Product Efficacy: RHOFADE has been proven effective in reducing persistent facial erythema associated with rosacea.
• Revenue Increase: RHOFADE saw significant revenue growth in the first quarter of 2023 despite manufacturing delays.
• Operational Challenges: High operating expenses and potential manufacturing delays are key challenges.
• Market Opportunities: Growing prevalence of rosacea and expanding market in the Asia Pacific region offer significant opportunities.

FAQs

Q: What is RHOFADE used for?

A: RHOFADE is used for the topical treatment of persistent facial erythema associated with rosacea in adults.

Q: When was RHOFADE approved by the FDA?

A: RHOFADE was approved by the FDA in January 2017[4].

Q: What are the common side effects of RHOFADE?

A: Common side effects include application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritus, application site erythema, and application site pain[3].

Q: How has RHOFADE performed in terms of sales?

A: RHOFADE saw an 11% growth in prescriptions in the first quarter of 2023 compared to the same period in 2022, despite a temporary decline due to manufacturing delays[2].

Q: What are the key drivers for the rosacea treatment market?

A: The increasing prevalence of rosacea, high awareness levels in North America, and improving access to diagnosis and treatment in the Asia Pacific region are key drivers[1].

Sources

1. Coherent Market Insights: Rosacea Treatment Market - Share, Size and Industry Analysis.
2. BioSpace: Novan Reports First Quarter 2023 Financial Results and Provides Corporate Update.
3. RHOFADE Prescribing Information: RHOFADE cream prescribing information.
4. PR Newswire: Allergan Announces FDA Approval Of RHOFADE™ (Oxymetazoline Hydrochloride) Cream.
5. GlobeNewswire: Novan Reports First Quarter 2023 Financial Results and Provides Corporate Update.