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. Ten 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 SUN PHARMA CANADA 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:	89
Clinical Trials:	1
Patent Applications:	4,729
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
South Korea	20110138353
Israel	214520	תכשירי קצף מקומיים המכילים טאזארוטן ושימושם בהכנת תרופה לטיפול במחלות עור (Topical foam compositions comprising tazarotene and use thereof for the manufacture of medicaments for the treatment of skin diseases)
Singapore	173563

Supplementary Protection Certificates for FABIOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203

Market Dynamics and Financial Trajectory for Fabior (Tazarotene) in the Pharmaceutical Sector

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape is continually evolving, driven by breakthroughs in molecular medicine, regulatory shifts, and changing market demands. Fabior, an ointment formulation of tazarotene, is a topical retinoid primarily approved for the treatment of plaque psoriasis and acne vulgaris. Understanding Fabior's market dynamics and financial trajectory involves analyzing its therapeutic niche, competitive positioning, regulatory landscape, and potential growth factors. This analysis provides essential insights for stakeholders aiming to evaluate investment opportunities or strategic positioning within the dermatology segment.

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Pharmacological Profile and Therapeutic Indications of Fabior

Fabior contains tazarotene, a third-generation retinoid that modulates keratinocyte proliferation and differentiation. Its efficacy in reducing psoriatic plaques and acne lesions has cemented its role in dermatological treatment protocols[1]. The meticulous pharmacodynamics of tazarotene confer advantages such as targeted action, comparatively fewer systemic side effects, and a favorable safety profile when used per prescribing guidelines.

The drug’s clinical utility extends into managing moderate to severe plaque psoriasis and acne vulgaris, with a preference for patients who are unresponsive to or intolerant of other topical therapies[2]. Its topical application reduces systemic exposure, limiting adverse effects and enhancing patient compliance, factors central to its market success.

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Market Dynamics

1. Market Size and Growth Potential

The global dermatology therapeutics market, valued at approximately USD 24 billion in 2022, demonstrates consistent growth driven by increasing prevalence of dermatological conditions, rising awareness, and advancements in topical treatments[3]. Specifically, the psoriasis segment is projected to expand at a compound annual growth rate (CAGR) of roughly 8%, with a significant contribution from products like Fabior.

In the United States, psoriasis affects approximately 2-3% of the population, translating into over 8 million affected individuals[4]. As current treatments like biologics remain costly and involve invasive administration, topical agents such as Fabior present compelling options, especially in mild to moderate cases or as adjunct therapy.

2. Competitive Landscape

The topical psoriasis treatment market encompasses several classes, including corticosteroids, vitamin D analogs, calcineurin inhibitors, and newer biologic agents[5]. Fabior's primary competitors include:

• Calcipotriol and other vitamin D analogs
• Tazarotene gel formulations by other manufacturers
• Combination therapies combining corticosteroids or vitamin D analogs with tazarotene
• Emerging topical agents in late-stage development

While biologic therapies like adalimumab and secukinumab command higher prices and target moderate to severe psoriasis, topicals like Fabior occupy a critical niche for mild to moderate cases, offering cost-effective and non-invasive options.

3. Regulatory Environment

Fabior received FDA approval in 2010 for the treatment of plaque psoriasis[6]. Since then, regulatory policies promoting generic entry have impacted its pricing and market share. Patents on the original formulation have expired or are nearing expiration, with generic tazarotene products expanding available options, intensifying market competition and pressure on pricing.

Furthermore, regulatory bodies increasingly favor topical agents with proven safety profiles, thereby fostering favorable conditions for Fabior, provided it meets efficacy and safety standards.

4. Pricing and Reimbursement Dynamics

Pricing strategies are pivotal in Fabior's market penetration. As a branded topical retinoid, it commands premium pricing relative to generic alternatives. Reimbursement policies, especially within the U.S., significantly influence patient access—payers may favor cost-effective generic options, thereby challenging Fabior's market dominance.

Despite this, strong clinical efficacy, brand recognition, and patient adherence support its continued use. Additionally, patient assistance programs and copay subsidies enhance accessibility.

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Financial Trajectory Analysis

1. Revenue Trends and Historical Performance

Initial sales post-Fabior's launch showcased steady growth owing to its differentiated efficacy profile. However, revenue trajectories are increasingly influenced by the entry of generics and market saturation.

Pharmaceutical companies typically see a decline in revenues around patent expiration, unless strategic measures such as line extensions, combination formulations, or geographic expansion are pursued.

2. Strategic Opportunities for Growth

• Line Extensions: Developing combination products with moisturizers or other topical therapeutics to enhance efficacy and adherence.
• Geographic Expansion: Entering emerging markets with rising dermatology treatment needs, such as Asia-Pacific and Latin America.
• Formulation Innovations: Transitioning to once-daily formulations or incorporating advanced delivery systems can offset generic competition.
• Biological and Systemic Alternatives: Positioning Fabior as part of combination therapy regimens alongside systemic agents.

3. Risks and Challenges

• Generic Competition: Erosion of market share as patent protections lapse.
• Pricing Pressures: Payer negotiations and formulary exclusions impacting sales.
• Market Saturation: Limited scope for growth in mature markets.
• Regulatory and Manufacturing Costs: Risks associated with maintaining compliance and scaling production.

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Key Drivers Influencing Future Market Performance

• Prevalence of Psoriasis and Acne: Rising incidence, especially among younger populations, sustains demand.
• Clinical Efficacy and Safety Profile: Favorable data underpin continued prescribing.
• Healthcare Provider Preferences: Adoption of topical therapies as first-line treatments.
• Patient Preferences: Demand for non-invasive, easy-to-use treatments.
• Competitive Innovation: Introduction of next-generation retinoids or combination drugs.

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Conclusion

Fabior’s market dynamics hinge on its positioning within the highly competitive dermatology arena. A strategic focus on innovation, diversification, and geographic expansion could counterbalance challenges posed by patent expirations and generics. Its financial trajectory will likely follow a maturation curve characterized by initial growth, subsequent stabilization, and potential decline unless proactive initiatives are undertaken.

Evolution in treatment paradigms favoring topical agents in mild to moderate psoriasis and acne, alongside emerging formulation technologies, offers avenues for sustaining and enhancing Fabior’s market presence.

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Key Takeaways

• Market Size & Segments: The global dermatology market, especially psoriasis and acne treatments, presents substantial growth opportunities, with topical agents like Fabior serving vital niches.
• Competitive Pressures: Patent expirations and generic manufacturers intensify price competition; differentiation through formulation and strategic expansion is vital.
• Regulatory & Reimbursement Factors: Evolving policies may influence access and pricing—alignment with payer expectations is essential.
• Innovation & Diversification: Product line extensions and novel formulations are crucial to maintaining competitive advantage.
• Growth Strategies: Geographical expansion, combination therapies, and targeting emerging markets can bolster revenue streams.

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FAQs

1. What is the primary therapeutic target of Fabior?
Fabior (tazarotene) targets keratinocyte proliferation and differentiation pathways, effectively reducing psoriatic plaques and acne lesions through retinoid receptor modulation.

2. How does Fabior compare to other topical treatments for psoriasis?
Fabior offers targeted efficacy with minimal systemic absorption, translating into a favorable safety profile. It is often preferred for patients unresponsive to or intolerant of corticosteroids or vitamin D analogs, although it faces competition from these agents on efficacy and cost.

3. What are the patent implications for Fabior?
Patent protections for original formulations have largely expired or are expiring soon, increasing the risk of generic competition, which could impact market share and pricing strategies.

4. Can Fabior expand into new indications?
Currently approved for psoriasis and acne, exploring additional dermatological conditions characterized by abnormal keratinocyte proliferation may open new avenues, subject to clinical validation and regulatory approval.

5. What strategic moves can companies pursue to sustain Fabior’s market relevance?
Developing combination therapies, innovating formulation technology, expanding into emerging markets, and pursuing line extensions are vital strategic options to counteract patent expiry impacts and sustain revenue growth.

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References

[1] American Academy of Dermatology Association. Tazarotene (Topical). Available from: https://www.aad.org/public/diseases/psoriasis/tazarotene

[2] Menter A., et al. (2012). Efficacy and safety of tazarotene in psoriasis: A systematic review. J Dermatol Treat.

[3] MarketsandMarkets. (2022). Dermatology Drugs Market Size & Share.

[4] World Psoriasis Atlas, 2021. Prevalence and burden of psoriasis.

[5] GlobalData Pharma Intelligence. (2023). Topical psoriasis treatments market analysis.

[6] FDA. (2010). FDA Approves Tazarotene Cream for Psoriasis.

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