FABIOR Drug Patent Profile

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

Fabior is a drug marketed by Mayne Pharma and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in FABIOR is tazarotene. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fabior

A generic version of FABIOR was approved as tazarotene by TARO on April 3^rd, 2017.

Summary for FABIOR

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	1
Patent Applications:	5,489
Drug Prices:	Drug price information for FABIOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FABIOR
What excipients (inactive ingredients) are in FABIOR?	FABIOR excipients list
DailyMed Link:	FABIOR at DailyMed

See drug prices for FABIOR

Recent Clinical Trials for FABIOR

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

Sponsor	Phase
Actavis Inc.	Phase 3

See all FABIOR clinical trials

Pharmacology for FABIOR

Drug Class

Retinoid

US Patents and Regulatory Information for FABIOR

FABIOR is protected by three 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	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes			Y

International Patents for FABIOR

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

Country	Patent Number	Title	Estimated Expiration
Japan	6182191
European Patent Office	2400951	COMPOSITION DE MOUSSE À USAGE TOPIQUE (TOPICAL FOAM COMPOSITION)
Eurasian Patent Organization	201171079

Supplementary Protection Certificates for FABIOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730

FABIOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FABIOR

Introduction

FABIOR, a topical foam formulation of tazarotene, is a prescription medication used for the treatment of moderate to severe acne. To understand the market dynamics and financial trajectory of FABIOR, it is essential to delve into various aspects including clinical efficacy, pricing strategies, market competition, and financial performance.

Clinical Efficacy and Trials

FABIOR Foam has been extensively studied in clinical trials to establish its efficacy in treating acne. Two randomized, double-blind, vehicle-controlled studies involving 1485 patients aged 12 to 45 years were conducted. These studies showed significant improvements in lesion counts and the Investigator’s Global Assessment (IGA) scale, with treatment success defined as an IGA score of "clear" or "almost clear" and at least a 2-grade improvement from the baseline score at week 12[4].

Market Positioning

Target Market

FABIOR is targeted at patients with moderate to severe acne, a common dermatological condition. The market for acne treatments is substantial, given the prevalence of the condition among adolescents and young adults. The clinical trials demonstrated that FABIOR is effective across a diverse patient population, including different age groups and ethnicities[4].

Competition

The acne treatment market is highly competitive, with various topical and oral medications available. FABIOR competes with other branded and generic treatments, including retinoids, antibiotics, and combination therapies. The unique formulation of FABIOR as a foam, which is often preferred for its ease of use and lower irritation profile compared to traditional gels or creams, helps it stand out in the market.

Pricing Strategies

Cost and Pricing

The pricing of FABIOR is influenced by several factors, including the cost of development, production, and market conditions. Pharmaceutical companies often set prices based on the value the drug brings to patients, as well as the competitive landscape. For instance, maintenance drugs like FABIOR may be priced differently depending on the insurance coverage and patient copays. In some plans, FABIOR might fall under a higher copay tier, affecting patient affordability and adherence[5].

Price Increases and Adjustments

Pharmaceutical companies periodically review and adjust the prices of their products. These adjustments can be influenced by various factors such as changes in raw material costs, manufacturing processes, and regulatory requirements. For example, price increases in pharmaceuticals are often done in stages to manage the impact on patients and the healthcare system, ensuring they remain below certain reporting thresholds[1].

Financial Performance

Revenue and Sales

The financial performance of FABIOR is tied to its sales and market share. As a branded product, FABIOR generates significant revenue for its manufacturer. The sales figures are influenced by the drug's efficacy, patient satisfaction, and prescribing patterns by dermatologists. Strong clinical trial results and positive patient outcomes contribute to higher sales and revenue.

Market Share and Growth

FABIOR's market share in the acne treatment market is a critical indicator of its financial health. The product's unique formulation and proven efficacy help it maintain a competitive edge. Market growth is also driven by increasing awareness of acne treatments and the expanding patient population seeking effective solutions.

Regulatory and Reimbursement Environment

Insurance Coverage and Reimbursement

The reimbursement environment plays a crucial role in the financial trajectory of FABIOR. Insurance coverage and copay structures can significantly impact patient access and adherence to the medication. For instance, if FABIOR is classified as a maintenance drug under certain insurance plans, patients may benefit from reduced copays for mail-order prescriptions, which can increase sales volume[5].

Regulatory Approvals and Compliance

Regulatory approvals and compliance are essential for the continued market presence of FABIOR. Manufacturers must adhere to stringent regulatory standards, including those related to manufacturing, labeling, and post-marketing surveillance. Compliance with these regulations ensures the drug's safety and efficacy are maintained, which is vital for sustaining market confidence and financial performance.

Impact of Precision Medicine and Innovation

Precision Medicine Trends

The pharmaceutical industry is increasingly focusing on precision medicines, which target specific patient populations. While FABIOR is not a precision medicine per se, the trend towards more targeted therapies can influence the broader market dynamics. For instance, the development of precision medicines can lead to higher prices due to the high value they bring to specific patient populations, which may indirectly affect the pricing strategies of other treatments like FABIOR[3].

Innovation in Drug Development

Innovation in drug development, including advancements in formulation and delivery systems, can impact the market position of FABIOR. Continuous innovation is necessary to maintain competitiveness and address evolving patient needs. For example, improvements in foam technology or the development of combination products could enhance FABIOR's market appeal and financial performance.

Patient Access and Affordability

Patient Copays and Out-of-Pocket Costs

Patient access to FABIOR is influenced by the out-of-pocket costs, which include copays and any additional expenses not covered by insurance. High copays can deter patients from adhering to their treatment plans, affecting the drug's sales and overall financial performance. Manufacturers often work with payers and patient advocacy groups to ensure affordable access to their medications[5].

Patient Assistance Programs

To improve patient access, manufacturers may offer patient assistance programs, such as discounts, rebates, or free trial offers. These programs can help mitigate the financial burden on patients and enhance the drug's market penetration.

Key Takeaways

• Clinical Efficacy: FABIOR has demonstrated significant efficacy in treating moderate to severe acne through clinical trials.
• Market Positioning: FABIOR competes in a crowded acne treatment market but stands out due to its unique foam formulation.
• Pricing Strategies: Pricing is influenced by development costs, market conditions, and regulatory requirements.
• Financial Performance: Revenue and sales are driven by efficacy, patient satisfaction, and market share.
• Regulatory Environment: Compliance with regulatory standards and favorable reimbursement policies are crucial.
• Innovation and Precision Medicine: Continuous innovation and trends in precision medicine can impact FABIOR's market dynamics.

FAQs

What is FABIOR used for?

FABIOR is a prescription medication used for the treatment of moderate to severe acne.

How effective is FABIOR in clinical trials?

FABIOR has shown significant improvements in lesion counts and the Investigator’s Global Assessment (IGA) scale in clinical trials, with treatment success defined as an IGA score of "clear" or "almost clear" and at least a 2-grade improvement from the baseline score at week 12[4].

How does FABIOR compete in the acne treatment market?

FABIOR competes with other branded and generic treatments but stands out due to its unique foam formulation, which is often preferred for its ease of use and lower irritation profile.

What factors influence the pricing of FABIOR?

The pricing of FABIOR is influenced by the cost of development, production, market conditions, and regulatory requirements.

How does insurance coverage affect FABIOR's financial performance?

Insurance coverage and copay structures can significantly impact patient access and adherence to FABIOR, thereby affecting its sales and revenue. Favorable reimbursement policies can enhance the drug's financial performance[5].

Sources

1. 2022 Price Increase Reports - Texas Department of State Health Services
2. Rural Cooperatives - USDA Rural Development
3. The Economics of Drug Development: Pricing and Innovation - National Bureau of Economic Research
4. Clinical Trials and Efficacy - FABIOR
5. LivingWell PPO Prescription Drug Plan - Kentucky Employee Health Plan