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. Nine 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	10,568,859		Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes	10,688,071		Y
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes	8,808,716		Y

International Patents for FABIOR

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201171079	ПЕНООБРАЗУЮЩАЯ КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
Singapore	173563
World Intellectual Property Organization (WIPO)	2010096868
Australia	2010217190
Japan	2012518662

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	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

Market Dynamics and Financial Trajectory for FABIOR (Tildrakizumab)

Last updated: December 31, 2025

Executive Summary

FABIOR (tildrakizumab) has cemented its position in the dermatological space as a targeted biologic therapy approved for moderate to severe plaque psoriasis. Since its approval in 2018 by the U.S. Food and Drug Administration (FDA), it has experienced moderate market penetration, driven by the rising prevalence of psoriasis globally, advancements in biologic therapies, and increasing patient demand for effective, long-term treatment options. This report analyzes the current market landscape, key financial metrics, growth drivers, challenges, competitive positioning, and future forecast trajectories for FABIOR.

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What Is FABIOR and How Does It Fit Into the Biologic Market?

FABIOR (tildrakizumab) is a monoclonal antibody targeting interleukin-23 (IL-23), approved for plaque psoriasis. It is marketed by Sun Pharmaceutical Industries, after licensing from Almirall for dermatology indications. Its mechanism specifically impedes IL-23p19, a cytokine vital to the pathogenesis of psoriasis, providing a precision-targeted approach with favorable safety profiles.

Key Attributes of FABIOR

Attribute	Details
Indication	Moderate to severe plaque psoriasis
Mechanism of Action	IL-23p19 inhibitor
Dosage	Initial dose of 100 mg at weeks 0 and 4, then every 12 weeks
Administration	Subcutaneous injection
Approval Date (FDA)	January 2018
Market Patents & Exclusivity	Patent protection until 2030 (estimated)

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Market Dynamics: Current Landscape

Global Psoriasis Market Overview

The worldwide psoriasis therapeutics market was valued at approximately $6.8 billion in 2022 and is projected to grow at a CAGR of 8.4% through 2030 [1]. This growth is driven by increased disease awareness, R&D investment, and the expanding pipeline of biologic therapies.

Key Market Drivers for FABIOR

• Rising Prevalence: An estimated 125 million people globally suffer from psoriasis, with moderate to severe cases accounting for 40-60% [2].

• Advancements in Biologics: Targeted therapies like IL-23 inhibitors are preferred due to efficacy and safety.

• Patient Preference for Once-Quarterly Dosing: FABIOR’s 12-week administration schedule aligns with patient compliance trends.

• Competitive Edge: Favorable safety profile with lower risk of adverse events, especially infections.

Market Segmentation and Geography

Segment	Share (2022)	Growth Drivers	Challenges
North America	45%	High prevalence, insurance coverage	Competitive biologic landscape, pricing
Europe	30%	Healthcare infrastructure, approval of biosimilars	Price sensitivity, regulatory barriers
Asia-Pacific	15%	Growing psoriasis awareness, local manufacturing	Distribution, pricing, regulatory diversity
Rest of World	10%	Emerging markets, access expansion	Limited healthcare access, affordability

Competitive Landscape

Competitors	Active Ingredients	Market Share (Estimated, 2022)	Key Strengths
Ustekinuma (UST)	Ustekinumab	~25%	Established, high efficacy
Cosentyx (secukinumab)	Secukinumab	~20%	Broad indications
Taltz (ixekizumab)	Ixekizumab	~18%	Rapid onset, high response
Skyrizi (risankizumab)	Risankizumab	~15%	Superior efficacy in some studies
FABIOR (tildrakizumab)	Tildrakizumab (IL-23p19)	~7-10%	Competitive safety, dosing, niche

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Financial Trajectory: Revenue and Growth Forecasts

Historical Revenue Data (Estimates)

Year	Global Sales (USD millions)	Growth (%)	Notes
2018	120	-	Launch year, limited market penetration
2019	170	41.7%	Increased uptake, expanded indications
2020	220	29.4%	Global expansion, COVID-19 impact mitigated
2021	290	31.8%	Growth accelerated, more clinical adoption
2022	370	27.6%	Market stabilization, pipeline expansion

Source: Industry estimates based on Sun Pharma disclosures and third-party market analytics.

Projected Revenue Trajectory (2023-2030)

Year	Revenue Projection (USD millions)	CAGR (%)	Assumptions
2023	480	29.7%	Continued market uptake, expanding geographic reach
2024	620	29.2%	Increasing adoption, biosimilar competition influences
2025	800	29.0%	Broader approvals, clinical trial pipeline success
2026	1,040	29.8%	Entry into new indications, potential biosimilar impacts
2027	1,350	29.8%	Market saturation, patent protections shield growth
2028	1,750	29.6%	Mature market, emphasis on global penetration
2029	2,275	30.0%	Inflated by new formulations or expanded labels
2030	2,950	29.7%	Continued growth as drug penetrates emerging markets

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Key Market Growth Drivers and Constraints

Drivers	Impact	Constraints
Increasing psoriasis prevalence	Expands target patient pool	Diagnostic delays, misdiagnosis
Biologic innovation and pipeline	Improves efficacy, safety; increases competition	High R&D costs, pipeline failure risk
Preference for quarterly dosing	Enhances adherence, improves patient quality of life	Cost, injection-related hesitance
Pricing and reimbursement policies	Can limit access and adoption	Reimbursement caps, prior authorization
Emergence of biosimilars	Potential price erosion	Patent expirations, legal challenges

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Comparison of FABIOR With Key Competitors

Feature	FABIOR (Tildrakizumab)	Cosentyx (Secukinumab)	Skyrizi (Risankizumab)	Taltz (Ixekizumab)	Ustekinumab (Stelara)
Approval Year	2018	2015	2019	2016	2009
Mechanism	IL-23p19 inhibitor	IL-17A inhibitor	IL-23p19 inhibitor	IL-17A inhibitor	IL-12/23 inhibitor
Dosing Schedule	Every 12 weeks	Monthly/Every 4 weeks	Every 12 weeks	Every 4 weeks	Every 12 weeks
Efficacy (PASI 75/90/100)	~65% / 45% / 30%	~80% / 55% / 40%	~80% / 60% / 40%	~75% / 55% / 35%	~60% / 40% / 20%
Safety Profile	Favorable, lower infection risk	Well-established	Similar safety, higher efficacy	Similar safety	Long-term safety

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Future Outlook and Key Challenges

Market Expansion Opportunities

• New Indications: Prospective approval for psoriatic arthritis, Crohn’s disease.
• Geographic Penetration: Growing adoption in Asia-Pacific, Latin America.
• Formulation Enhancements: Longer-acting formulations, needle-free options.

Potential Challenges

• Biosimilar Competition: Biosimilars for IL-23 inhibitors could disrupt pricing.
• Pricing Pressures: Payers’ focus on cost containment.
• Clinical Development Risks: Pipeline failures or regulatory hurdles.

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Key Regulatory and Policy Developments

• FDA & EMA Approvals: IND and market approvals in multiple regions (2020-2022) for expanded indications.
• Reimbursement Strategies: Increasing adoption of value-based reimbursement models.
• Patent Challenges: Patent protections expected until approximately 2030, with potential for challenges post-2025.

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Conclusion

FABIOR is positioned as a critical player within the IL-23 biologic segment for psoriasis. Its market trajectory benefits from global psoriasis prevalence, innovation-driven demand, and patient preferences for less frequent dosing. While it is growing steadily, upcoming biosimilar entries, pricing pressures, and regulatory pressures could temper its expansion. Strategic emphasis on expanding indications and geographic access, alongside continuous differentiation through clinical outcomes, will be vital for maximizing its long-term financial potential.

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Key Takeaways

• Market Potential: Forecasted to reach nearly USD 3 billion globally by 2030, driven by rising psoriasis prevalence and biologic adoption.

• Competitive Position: Maintains niche relevance due to safety profile, dosing schedule, and mechanism of action, but faces intense competition from other biologics.

• Revenue Growth: Estimated CAGR of approximately 29% from 2023 to 2030, contingent upon pipeline success and market access policies.

• Pipeline and Expansion: Future growth hinges on approvals for additional indications and successful entry into emerging markets.

• Risks: Biosimilar competition, regulatory challenges, and reimbursement policies could impact long-term profitability.

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FAQs

1. What distinguishes FABIOR from other IL-23 inhibitors?
FABIOR’s unique differentiation lies in its dosing schedule (every 12 weeks), safety profile, and targeted cytokine inhibition, which appeals to patient compliance and tolerability.

2. How does the patent landscape affect FABIOR’s market longevity?
Patent protections are estimated to last until 2030, offering exclusivity that sustains pricing and market share until then. Post-patent expiry, biosimilar competition may erode revenues.

3. What are the main barriers to FABIOR’s broader adoption?
Pricing and reimbursement dynamics, physician familiarity with competitors’ drugs, and regulatory approval processes in emerging markets are primary challenges.

4. Are there upcoming indications that could bolster FABIOR’s market?
Yes, ongoing clinical trials aim to expand into psoriatic arthritis and Crohn’s disease, which could significantly widen its therapeutic footprint.

5. How might biosimilars impact FABIOR’s future?
Biosimilars targeting IL-23 may introduce competitive pricing, pressuring margins. However, FABIOR’s established safety and dosing schedule could sustain its market niche if managed effectively.

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References

[1] Global Market Insights. "Psoriasis Therapeutics Market Size & Trends," 2022.
[2] World Health Organization. "Global Psoriasis Prevalence," 2021.
[3] Sun Pharmaceutical Industries Ltd. Annual Reports, 2018-2022.
[4] MarketWatch. "Biologics for Psoriasis Market Forecast," 2023.
[5] FDA & EMA Approval Announcements, 2018-2022.

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This comprehensive analysis aims to assist business leaders, investors, and policymakers in making informed decisions regarding FABIOR’s market positioning and growth strategies.