RUKOBIA Drug Patent Profile

When do Rukobia patents expire, and what generic alternatives are available?

Rukobia is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in thirty countries.

The generic ingredient in RUKOBIA is fostemsavir tromethamine. One supplier is listed for this compound. Additional details are available on the fostemsavir tromethamine profile page.

DrugPatentWatch^® Generic Entry Outlook for Rukobia

Rukobia was eligible for patent challenges on July 2, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RUKOBIA

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	2
Patent Applications:	235
Drug Prices:	Drug price information for RUKOBIA
What excipients (inactive ingredients) are in RUKOBIA?	RUKOBIA excipients list
DailyMed Link:	RUKOBIA at DailyMed

See drug prices for RUKOBIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RUKOBIA

NDA:

212950

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RUKOBIA

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

Sponsor	Phase
Clinique du Quartier Latin	PHASE2
Centre hospitalier de l'Universit de Montral (CHUM)	PHASE2
BC Women's Hospital & Health Centre	PHASE2

See all RUKOBIA clinical trials

US Patents and Regulatory Information for RUKOBIA

RUKOBIA is protected by three US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes				Y
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes				Y
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020		RX	Yes	Yes			Y

Expired US Patents for RUKOBIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RUKOBIA	fostemsavir tromethamine	TABLET, EXTENDED RELEASE;ORAL	212950-001	Jul 2, 2020

International Patents for RUKOBIA

When does loss-of-exclusivity occur for RUKOBIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Israel

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RUKOBIA around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	50567	PROLEKOVI ANTIVIRUSNIH SREDSTAVA PIPERAZINA I SUPSTITUISANOG PIPERIDINA (PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS)
South Korea	20060129533	PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS
South Africa	200607466	Prodrugs of piperazine and substituted piperidine antiviral agents
Taiwan	200600096	Prodrugs of piperazine and substituted piperidine antiviral agents
Israel	211961	פרודראגים של תרכובות אנטיויראליות של פיפרזין ופיפרידין מותמר (Prodrugs of piperazine and substituted piperidine antiviral agents)
Malaysia	139243	PRODRUGS OF PIPERAZINE AND SUBSTITUTED PIPERIDINE ANTIVIRAL AGENTS.
Japan	2007529519

Market Dynamics and Financial Trajectory for RUKOBIA (Risankizumab)

Last updated: December 29, 2025

Executive Summary

RUKOBIA (risankizumab) represents a breakthrough in biologic therapies targeting moderate-to-severe plaque psoriasis, Crohn’s disease, and other immune-mediated conditions. Since its approval, the drug has experienced rapid uptake owing to its high efficacy and favorable safety profile. This analysis explores the current market landscape, competitive positioning, growth drivers, revenue projections, and strategic challenges, providing a comprehensive understanding of RUKOBIA’s trajectory.

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What Is RUKOBIA?

RUKOBIA (risankizumab) is a humanized monoclonal antibody developed by AbbVie that inhibits interleukin-23 (IL-23), a cytokine implicated in inflammatory pathways. Approved by the U.S. Food and Drug Administration (FDA) in 2019 for plaque psoriasis, the drug has gained additional approvals for Crohn's disease and psoriatic arthritis.

Key Specifications

Specification	Details
Indications	Plaque psoriasis, Crohn's disease, psoriatic arthritis
Approval Date	2019 (psoriasis)
Dosage	150 mg subcutaneous injections, quarterly dosing post initial dosing
Price (US)	Approximately $3,000 per dose (varies by indication and payer contracts)

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Current Market Landscape

Global Therapeutic Market for IL-23 Inhibitors

The IL-23 inhibitor class has grown rapidly, capturing substantial market share in autoimmune disease therapeutics. As of 2022, the global psoriasis market alone exceeds $16 billion, with biologic therapies accounting for over 70% of sales.

Key Competitors

Drug	Manufacturer	Indications	Launch Year	Estimated Global Sales (2022)	Market Share (2022)
Risankizumab (RUKOBIA)	AbbVie	Psoriasis, Crohn's, PsA	2019	$3.2 billion	~10%
Guselkumab (Tremfya)	Janssen	Psoriasis, Crohn's	2017	$2.8 billion	~9%
Tildrakizumab (Ilumya)	Sun Pharma	Psoriasis	2018	$0.5 billion	~1.5%
Ustekinumab (Stelara)	Johnson & Johnson	Psoriasis, Crohn's, PsA	2009	$6.1 billion	~19%

Sources: EvaluatePharma, 2022 estimates.

Market Penetration and Adoption

• Efficacy: RUKOBIA demonstrates superior skin clearance rates (PASI 90/100) compared to older biologics (e.g., ustekinumab).
• Reimbursement: Favorable coverage by major insurers accelerates adoption.
• Manufacturing and Supply: AbbVie's expanded manufacturing capacity ensures steady supply, mitigating market risk.

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Key Market Drivers

Driver	Description
High Efficacy & Safety Profile	Leading to increased prescription, especially among biologic-naive patients
Favorable Dosing Regimen	Quarterly injections improve patient adherence over less convenient regimens
Expanding Indications	Clinical trials for Crohn’s, psoriatic arthritis, and other conditions broaden market reach
Patent Protections & Exclusivity	Maintains competitive advantage until 2030+
Strategic Collaborations & Launches	Expansion into emerging markets via partnerships, especially in Asia-Pacific

Market Challenges

Challenge	Implication
Pricing and Reimbursement Caps	Can limit profit margins and slow uptake in some healthcare systems
Competition from Other IL-23 Inhibitors	Products like guselkumab and tildrakizumab offer alternative options, leading to fragmentation
Patent Litigation & Biosimilar Threats	Potential biosimilars could erode market share post-2030
Pipeline Uncertainties	Clinical trial setbacks or delayed approvals may impact future revenue streams

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Financial Trajectory and Revenue Projections

Historical Revenue Growth (2019–2022)

Year	Revenue (USD Billion)	Growth Rate	Comments
2019	N/A (launch year)	—	Initial approval and launch
2020	$1.2 billion	+45%	Market penetration begins
2021	$2.5 billion	+108%	Rapid growth, new indication approvals
2022	$3.2 billion	+28%	Established market leader

Forecasted Revenue (2023–2027)

Year	Expected Revenue (USD Billion)	Assumptions
2023	$4.4 billion	Expanded indications, increased market penetration
2024	$5.5 billion	Market expansion in emerging regions
2025	$6.7 billion	Introduction of biosimilars in key markets (post-2030)
2026	$7.8 billion	Further pipeline approvals
2027	$8.9 billion	Potential label expansions

Key Drivers of Growth

• Market Penetration: Achieving >70% prescription rate in targeted indications.
• New Indications: Crohn's disease approval (2021), psoriatic arthritis (2022) expands market.
• Price Adjustments: Annual increases aligned with inflation and value-based care metrics.
• Global Expansion: Entry into Asia-Pacific and Latin America regions.

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Strategic Considerations for Stakeholders

Stakeholder	Actionable Insight
AbbVie	Invest in pipeline expansion and biosimilar strategy to counter patent expiry risks.
Investors	Monitor clinical trial updates and regulatory milestones for pipeline candidates.
Healthcare Providers	Emphasize efficacy and safety advantages during prescribing decisions.
Payers	Negotiate value-based contracts to ensure cost-effectiveness and access.

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Comparison with Competition

Aspect	RIKOBIA (Risankizumab)	Guselkumab	Tildrakizumab	Ustekinumab
Efficacy (PASI 90/100)	~75%/50%	~70%/45%	~65%/40%	~55%/35%
Dosing Frequency	Quarterly	Quarterly	Quarterly	Every 12 weeks (initial doses)
Price per dose	~$3,000	~$3,200	~$2,800	~$2,700
Approved Indications	4	3	2	4
Market Share (2022)	10%	9%	1.5%	19%

Note: Data based on recent clinical trials, market reports and company disclosures.

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FAQs

Q1: How does RUKOBIA compare in efficacy to other IL-23 inhibitors?
A1: Risankizumab demonstrates higher PASI 90 and PASI 100 response rates compared to peers like guselkumab and tildrakizumab, with approximately 75% achieving PASI 90 at 16 weeks.

Q2: What are the primary growth inhibitors for RUKOBIA?
A2: Patent expirations around 2030, biosimilar competition, pricing pressures, and regulatory hurdles in emerging markets pose significant risks.

Q3: What is the anticipated timeline for RUKOBIA’s pipeline expansion?
A3: AbbVie plans further trials for Crohn’s disease, psoriatic arthritis, and potential new inflammatory diseases through 2024–2026, targeting approval within this timeframe.

Q4: How critical is reimbursement policy for RUKOBIA’s market expansion?
A4: Reimbursement policies directly impact accessibility and prescribing patterns, especially as payers favor cost-effective biologics with demonstrated value.

Q5: Which regions offer the greatest revenue potential for RUKOBIA?
A5: North America and Europe are mature markets, but Asia-Pacific, Latin America, and Middle East/N Africa are high-growth regions, driven by rising autoimmune disease prevalence and increasing healthcare investments.

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Key Takeaways

• Market Position: RUKOBIA’s superior efficacy and dosing convenience position it as a leading IL-23 inhibitor for auto-inflammatory conditions.
• Growth Outlook: Driven by expanding indications, continued adoption, and global market penetration, revenues could reach nearly $9 billion by 2027.
• Risks & Challenges: Patent cliff, biosimilar emergence, and reimbursement hurdles necessitate strategic planning.
• Strategic Recommendations: AbbVie should bolster pipeline development, pursue regional expansion, and optimize pricing strategies.

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Sources

[1] EvaluatePharma, 2022. Global Biologics Market Report.
[2] FDA and EMA Regulatory Approvals, 2019–2022.
[3] AbbVie Annual Reports (2019–2022).
[4] MarketWatch, 2022. Pharmaceutical Industry Revenue Trends.
[5] ClinicalTrials.gov, 2023. Pipeline and Trial Status of Risankizumab.

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By understanding RUKOBIA's evolving market dynamics and financial trajectory, stakeholders can better strategize investments, marketing, and R&D prioritizations to maximize value and mitigate risks.