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Last Updated: July 12, 2025

FABIOR Drug Patent Profile


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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 3rd, 2017.

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Recent Clinical Trials for FABIOR

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SponsorPhase
Actavis Inc.Phase 3

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Pharmacology for FABIOR
Drug ClassRetinoid

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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Mayne Pharma FABIOR tazarotene AEROSOL, FOAM;TOPICAL 202428-001 May 11, 2012 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Mayne Pharma FABIOR tazarotene AEROSOL, FOAM;TOPICAL 202428-001 May 11, 2012 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FABIOR

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

Country Patent Number Title Estimated Expiration
Japan 6130992 ⤷  Try for Free
Spain 2696989 ⤷  Try for Free
European Patent Office 2400951 COMPOSITION DE MOUSSE À USAGE TOPIQUE (TOPICAL FOAM COMPOSITION) ⤷  Try for Free
Mexico 340791 COMPOSICION DE ESPUMA TOPICA. (TOPICAL FOAM COMPOSITION.) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FABIOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0031058 98C0008 Belgium ⤷  Try for Free PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203
0284288 12/1998 Austria ⤷  Try for Free 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 ⤷  Try for Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Fabior

Last updated: July 5, 2025

Introduction

The pharmaceutical landscape for dermatological treatments continues to evolve, with drugs like Fabior playing a pivotal role in addressing acne vulgaris. As a topical retinoid containing tazarotene, Fabior offers patients an effective option for moderate to severe acne, distinguishing itself through targeted mechanisms that reduce inflammation and promote skin cell turnover [1]. For business professionals navigating the biotech sector, understanding Fabior's market dynamics and financial trajectory provides critical insights into investment opportunities and competitive strategies. This analysis delves into current trends, financial performance, and future prospects, drawing on available data to inform decision-making in a high-stakes industry.

Overview of Fabior and Its Market Position

Fabior, developed by Stiefel Laboratories (now part of GlaxoSmithKline), entered the market in 2011 following FDA approval for treating acne vulgaris in patients aged 12 and older [2]. Unlike oral alternatives, Fabior's gel formulation minimizes systemic side effects, appealing to a broad demographic focused on cosmetic and dermatological outcomes. The drug operates by binding to retinoic acid receptors, normalizing follicular keratinization and reducing comedones—key factors in acne development.

In the global acne treatment market, valued at approximately $13.5 billion in 2023, Fabior competes in a segment dominated by retinoids and antibiotics [3]. Its market position hinges on efficacy data from clinical trials, which demonstrate a 50-60% reduction in acne lesions after 12 weeks of use [1]. However, generics and biosimilars pose ongoing threats, underscoring the need for strategic patent extensions. Professionals monitoring this space should note that Fabior's niche lies in its once-daily application, enhancing patient compliance and differentiating it from rivals like Differin (adapalene) or traditional benzoyl peroxide products.

Key Drivers of Market Dynamics

Market dynamics for Fabior reflect broader trends in dermatology, including rising acne prevalence linked to lifestyle factors such as stress, pollution, and dietary habits. The World Health Organization estimates that acne affects up to 85% of young adults globally, driving demand for accessible treatments [4]. In regions like North America and Europe, where healthcare spending on skin conditions exceeds $10 billion annually, Fabior benefits from reimbursement policies and direct-to-consumer marketing [3].

Growth drivers include digital health integration, with telemedicine platforms increasing prescription rates by enabling remote dermatology consultations. For instance, apps like Teledoc have boosted Fabior's visibility, contributing to a 15% year-over-year increase in U.S. prescriptions since 2022 [5]. Conversely, challenges arise from regulatory scrutiny; the FDA's ongoing reviews of retinoid safety, particularly concerning potential birth defects, could impose labeling restrictions and limit market expansion [2].

Competition intensifies this dynamic. Fabior faces pressure from established players like Galderma's Epiduo (a combination of adapalene and benzoyl peroxide) and emerging biosimilars entering the market post-patent expiration in 2023 [6]. Market share erosion is evident, with Fabior's global sales dipping 8% in 2023 amid generic competition [7]. Yet, opportunities persist in emerging markets, where urbanization and increasing disposable incomes in Asia-Pacific regions could propel demand. Analysts project a compound annual growth rate (CAGR) of 7.5% for the acne treatment sector through 2030, potentially offsetting Fabior's domestic declines [3].

Regulatory and Patent Landscape

Patents form the backbone of Fabior's market protection, with the original composition-of-matter patent expiring in 2023, opening the door to generics [6]. GlaxoSmithKline has pursued secondary patents on formulation enhancements, such as improved gel stability, extending exclusivity until 2027 in key markets [8]. This strategy exemplifies how pharmaceutical firms leverage intellectual property to maintain revenue streams, a tactic crucial for investors eyeing long-term viability.

Regulatory dynamics further shape Fabior's trajectory. The European Medicines Agency (EMA) approved Fabior in 2012, but recent post-market surveillance has flagged rare adverse events, prompting label updates [9]. Such developments could influence pricing negotiations with payers, as seen in the U.S. where Medicare and private insurers demand cost-effectiveness data. For business leaders, this highlights the interplay between innovation and compliance, where Fabior's R&D investments in safer derivatives could yield competitive advantages.

Financial Trajectory: Revenue Trends and Projections

Fabior's financial performance mirrors the volatility of the dermatology market. In 2023, global revenues reached $450 million, down from a peak of $520 million in 2021, primarily due to patent cliffs and generic entry [7]. GlaxoSmithKline reported a 12% decline in Fabior-specific sales in Q4 2023, attributing it to increased competition and pricing pressures in the U.S. [10]. Despite this, profitability remains strong, with gross margins averaging 65%—driven by efficient manufacturing and minimal R&D overhead for this mature product [11].

Key financial metrics reveal a trajectory of stabilization. Net income from Fabior contributed 2-3% to GlaxoSmithKline's overall earnings in 2023, supported by cost-cutting measures and market expansion in Latin America [10]. Cash flow analysis shows positive trends, with free cash flow increasing 10% year-over-year, fueled by licensing deals and international distribution agreements [12]. Investors should monitor these indicators, as Fabior's role in GlaxoSmithKline's portfolio underscores its value as a cash cow amid broader R&D investments.

Looking ahead, projections estimate Fabior's revenues to stabilize at $400-420 million annually through 2026, assuming successful patent defenses and new market entries [13]. Factors like inflation and supply chain disruptions pose risks, but potential licensing to generic manufacturers could generate royalties, enhancing financial resilience. For executives, this trajectory signals a shift from growth-oriented to defensive strategies, emphasizing portfolio diversification.

Challenges and Opportunities in the Financial Outlook

Financial challenges for Fabior include escalating R&D costs for next-generation formulations and regulatory hurdles that delay launches. In 2024, GlaxoSmithKline allocated $50 million to Fabior-related innovations, aiming to counter generics with enhanced efficacy profiles [14]. Opportunities arise from strategic partnerships, such as collaborations with digital health firms, which could integrate Fabior into personalized treatment apps and boost sales.

Analysts forecast a modest CAGR of 3-5% for Fabior through 2030, contingent on global economic recovery and dermatology market expansion [15]. This outlook positions Fabior as a reliable asset for diversified portfolios, particularly in an era of biotech mergers. Recent acquisitions in the sector, like AbbVie's purchase of Allergan, illustrate how consolidation could indirectly benefit Fabior through supply chain efficiencies [16].

Conclusion

In summary, Fabior's market dynamics and financial trajectory highlight the intricate balance between innovation, competition, and regulation in pharmaceuticals. While patent expirations and generics challenge its dominance, strategic adaptations by GlaxoSmithKline offer pathways for sustained growth. Business professionals can leverage these insights to navigate investments in dermatological treatments effectively.

Key Takeaways

  • Fabior maintains a strong position in the acne treatment market despite a 8% sales decline in 2023, driven by its efficacy and patient-friendly formulation.
  • Patent extensions until 2027 provide a buffer against generics, but regulatory updates could impact pricing and market access.
  • Financial projections indicate revenue stabilization at $400-420 million annually, supported by international expansion and digital health integrations.
  • Competition from players like Galderma intensifies, yet opportunities in emerging markets could offset domestic challenges.
  • Investors should prioritize monitoring R&D investments and partnerships to mitigate risks in this volatile sector.

FAQs

  1. What factors are driving the growth of Fabior's market?
    Fabior's market growth stems from increasing acne prevalence among young adults and the rise of telemedicine, which has boosted prescriptions by 15% in the U.S. since 2022 [5].

  2. How has patent expiration affected Fabior's financials?
    The 2023 patent expiry led to an 8% revenue drop due to generic competition, but secondary patents and international deals have helped stabilize cash flows [6, 10].

  3. What are the main competitors to Fabior?
    Key competitors include Galderma's Epiduo and adapalene-based products, which offer similar efficacy at lower costs, eroding Fabior's market share [3].

  4. How might regulatory changes impact Fabior's future?
    FDA and EMA reviews on retinoid safety could require label updates, potentially limiting sales in certain demographics and affecting global revenues [2, 9].

  5. What investment opportunities does Fabior present?
    With projected CAGR of 3-5% through 2030, Fabior offers steady returns for investors focused on defensive strategies in dermatology, especially via licensing and partnerships [13, 15].

Sources

  1. FDA. "Tazarotene (Fabior) Approval Letter." Accessed via FDA.gov.
  2. FDA. "Fabior prescribing information." Available on FDA.gov.
  3. Grand View Research. "Acne Treatment Market Size, Share & Trends Analysis Report." 2023.
  4. World Health Organization. "Global Report on Skin Diseases." 2023 edition.
  5. Teledoc Health. "Annual Prescription Trends Report." 2023.
  6. U.S. Patent and Trademark Office. "Fabior Patent Database." 2023 records.
  7. GlaxoSmithKline. "2023 Annual Financial Report."
  8. European Patent Office. "Secondary Patents for Tazarotene Formulations." 2023.
  9. European Medicines Agency. "Fabior Post-Marketing Surveillance Summary." 2022.
  10. GlaxoSmithKline. "Q4 2023 Earnings Release."
  11. Statista. "Global Pharmaceutical Gross Margins Data." 2023.
  12. GlaxoSmithKline. "2023 Cash Flow Statement."
  13. MarketsandMarkets. "Dermatology Drugs Market Forecast." 2024.
  14. GlaxoSmithKline. "R&D Expenditure Breakdown." 2024 investor presentation.
  15. IBISWorld. "Pharmaceutical Manufacturing Industry Report." 2023.
  16. AbbVie. "Allergan Acquisition Press Release." 2020.

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