FINACEA Drug Patent Profile

When do Finacea patents expire, and when can generic versions of Finacea launch?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in twenty countries.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Finacea

A generic version of FINACEA was approved as azelaic acid by ACTAVIS LABS UT INC on November 19^th, 2018.

Summary for FINACEA

International Patents:	137
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	12
Patent Applications:	4,129
Drug Prices:	Drug price information for FINACEA
Drug Sales Revenues:	Drug sales revenues for FINACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINACEA
What excipients (inactive ingredients) are in FINACEA?	FINACEA excipients list
DailyMed Link:	FINACEA at DailyMed

See drug prices for FINACEA

See drug sales revenues for FINACEA

Recent Clinical Trials for FINACEA

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Clinical Research Center of the Carolinas	Phase 4
Padagis LLC	Phase 3

See all FINACEA clinical trials

Pharmacology for FINACEA

Physiological Effect

Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Paragraph IV (Patent) Challenges for FINACEA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FINACEA	Topical Foam	azelaic acid	15%	207071	1	2017-09-14
FINACEA	Gel	azelaic acid	15%	021470	1	2012-07-27

US Patents and Regulatory Information for FINACEA

FINACEA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	10,117,812		Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,265,725		Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	8,435,498
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,211,259

Expired US Patents for FINACEA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	8,900,554
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	10,322,085
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	6,534,070
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	4,713,394

International Patents for FINACEA

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	284338
Spain	2299258
European Patent Office	1032379	COMPOSITION COMPRENANT DE L'ACIDE AZELAIQUE (COMPOSITION WITH AZELAIC ACID)
Mexico	PA05004278	ESPUMA COSMETICA Y FARMACEUTICA. (COSMETIC AND PHARMACEUTICAL FOAM.)

FINACEA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FINACEA

Market Overview

FINACEA, a topical gel and foam formulation containing azelaic acid, is a significant player in the treatment of mild to moderate rosacea. Here’s a detailed look at the market dynamics and financial trajectory of FINACEA.

Growth Drivers

Increasing Prevalence of Rosacea

The market for rosacea treatments, including FINACEA, is driven by the increasing prevalence of the condition. Rosacea affects a significant portion of the adult population, particularly those in their 30s to 50s, creating a substantial demand for effective treatments[1].

Rising Purchasing Power and Healthcare Expenditure

The growing purchasing power of consumers and escalating healthcare expenditure are key factors contributing to the growth of the rosacea market. As more people seek medical treatments for skin conditions, the demand for products like FINACEA increases[1].

Awareness and Personal Appearance

Increasing awareness about rosacea and its treatments, along with the growing importance of personal appearance, further drive the market. Patients are more likely to seek medical advice and treatments to manage their condition effectively[1].

Market Segmentation

Drug Type

The US rosacea market, where FINACEA is prominent, can be segmented into topical drugs and oral antibiotics. Topical drugs, such as FINACEA, dominate the market due to their efficacy and preference among patients and healthcare providers[1].

Brand Revenue

FINACEA, along with other brands like Metrogel, Oracea, and Soolantra, generates significant revenue in the rosacea market. In 2019, Metrogel and Oracea were among the top revenue-generating brands, with FINACEA also holding a substantial market share[1].

Financial Trajectory

Revenue Forecast

The US rosacea market, which includes FINACEA, is expected to reach $1.8 billion by 2024, growing at a CAGR of 5.92% from 2019 to 2024. This growth indicates a robust financial trajectory for FINACEA and other rosacea treatments[1].

Cost and Insurance Coverage

The cost of FINACEA can vary based on insurance plans, location, and pharmacy. Insurance companies often require prior authorization for coverage, which can impact the financial accessibility of the drug. However, the overall demand and insurance coverage contribute to its financial stability[2].

Regulatory and Safety Considerations

FDA Approval and Postmarketing Commitments

FINACEA was approved by the FDA in 2002 as a 15% topical gel and later as a foam formulation in 2015. The approval process included postmarketing commitments for studies to determine photocarcinogenic and dermal carcinogenicity risks. These regulatory requirements ensure the safety profile of FINACEA is continuously monitored and updated[3][5].

Safety Profile

FINACEA has demonstrated efficacy and safety in clinical trials. However, it is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. The drug has shown low systemic absorption and no significant genotoxic effects in various tests[4].

Treatment Efficacy and Long-Term Use

Clinical Efficacy

FINACEA has been shown to be effective in reducing inflammatory papules and pustules of mild to moderate rosacea. Clinical studies have demonstrated a significant reduction in lesion counts and improvement in the investigator’s global assessment of rosacea[4].

Long-Term Treatment

FINACEA is intended for long-term use. If there is no improvement after 12 weeks, the treatment plan is reassessed. This long-term use contributes to the sustained revenue and market presence of FINACEA[2].

Challenges and Opportunities

Generic Drugs and Side Effects

The entry of generic drugs and potential side effects of therapies are challenges that the rosacea market, including FINACEA, may face. However, the brand loyalty and established efficacy of FINACEA help mitigate these challenges[1].

Market Expansion

The increasing awareness and demand for rosacea treatments offer opportunities for market expansion. New formulations, such as the foam version of FINACEA, can attract more patients and healthcare providers, further solidifying its market position[5].

Key Takeaways

• Market Growth: The US rosacea market, driven by increasing prevalence and awareness, is expected to grow significantly.
• Revenue Forecast: FINACEA is part of a market projected to reach $1.8 billion by 2024.
• Regulatory Compliance: FINACEA has undergone rigorous FDA approval processes and postmarketing commitments to ensure safety.
• Efficacy and Long-Term Use: FINACEA is effective in treating rosacea and is intended for long-term use.
• Challenges and Opportunities: Despite challenges from generic drugs and side effects, FINACEA’s brand loyalty and new formulations offer opportunities for market expansion.

Frequently Asked Questions (FAQs)

1. What is FINACEA used for?

FINACEA is used for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

2. How effective is FINACEA in treating rosacea?

FINACEA has been shown to significantly reduce inflammatory papules and pustules and improve the overall appearance of rosacea in clinical studies[4].

3. Is FINACEA safe for long-term use?

Yes, FINACEA is intended for long-term use, but its effectiveness and safety are reassessed after 12 weeks if there is no improvement[2].

4. What are the common side effects of FINACEA?

Common side effects include redness, itching, and burning at the application site. However, FINACEA has a low systemic absorption and is generally well-tolerated[4].

5. Is FINACEA covered by insurance?

Yes, FINACEA is often covered by insurance, but prior authorization may be required. The cost varies based on the insurance plan, location, and pharmacy[2].

Cited Sources:

1. U.S. Acne & Rosacea Market: Insights, Trends & Forecast (2020-2024) - GlobeNewswire
2. Finacea (azelaic acid): Uses, dosage, side effects, and more - Medical News Today
3. A Review Of The Regulatory History Of Azelaic Acid And The Changing Requirements At FDA - Premier Consulting
4. FINACEA Gel, 15%, label - FDA
5. FINACEA (azelaic acid) Foam, 15% NDA 207071 - FDA