RINVOQ LQ Drug Patent Profile

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

Rinvoq Lq is a drug marketed by Abbvie and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and two patent family members in forty-one countries.

The generic ingredient in RINVOQ LQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Rinvoq Lq

Rinvoq Lq was eligible for patent challenges on August 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2036. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (upadacitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for RINVOQ LQ

International Patents:	202
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	42
Patent Applications:	33
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RINVOQ LQ
DailyMed Link:	RINVOQ LQ at DailyMed

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

NDA:

218347

Dosage:

SOLUTION;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 RINVOQ LQ

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

Sponsor	Phase
AbbVie	PHASE4
Berinstein, Jeffrey	PHASE4
AbbVie	PHASE3

See all RINVOQ LQ clinical trials

Pharmacology for RINVOQ LQ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

US Patents and Regulatory Information for RINVOQ LQ

RINVOQ LQ is protected by twelve US patents and two FDA Regulatory Exclusivities.

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
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes				Y
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes				Y
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes				Y

EU/EMA Drug Approvals for RINVOQ LQ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Rinvoq	upadacitinib	EMEA/H/C/004760Rheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritisRINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.	Authorised	no	no	no	2019-12-16

International Patents for RINVOQ LQ

When does loss-of-exclusivity occur for RINVOQ LQ?

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

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

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 RINVOQ LQ around the world.

Country	Patent Number	Title	Estimated Expiration
Dominican Republic	P2010000382	NUEVOS COMPUESTOS TRICICLICOS
Mexico	346959	NUEVOS COMPUESTOS TRICICLICOS. (NOVEL TRICYCLIC COMPOUNDS.)
Singapore	10201913993Q	PROCESSES FOR THE PREPARATION OF (3S,4R)-3-ETHYL-4-(3H-IMIDAZO[1,2-a]PYRROLO[2,3-e]-PYRAZIN-8-YL)-N-(2,2,2-TRIFLUOROETHYL)PYRROLIDINE-1-CARBOXAMIDE AND SOLID STATE FORMS THEREOF
Japan	2013512280

Supplementary Protection Certificates for RINVOQ LQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	CA 2020 00011	Denmark		PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716	723	Finland
2506716	132020000000022	Italy		PRODUCT NAME: UPADACITINIB IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(RINVOQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1404, 20191218
2506716	LUC00149	Luxembourg		PRODUCT NAME: UPADACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218

Market Dynamics and Financial Trajectory for Rinvoq (Upadacitinib)

Last updated: December 31, 2025

Summary

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor marketed by AbbVie for treating moderate-to-severe rheumatoid arthritis (RA) and other inflammatory conditions. Since its FDA approval in 2019, Rinvoq has rapidly expanded its indications, becoming a significant player in the competitive landscape of immunomodulators. This article examines the current market dynamics, sales trajectory, competitive positioning, regulatory landscape, and future growth prospects of Rinvoq, providing a comprehensive analysis for stakeholders aiming to understand its financial trajectory.

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What Are the Key Market Drivers for Rinvoq?

1. Expanding Therapeutic Indications

Indication	Approval Date	Marketed By	Estimated Patient Population	Notes
Rheumatoid Arthritis (RA)	August 2019	AbbVie	~1.5 million (U.S.)	First-line and advanced therapies
Atopic Dermatitis (AD)	April 2022	FDA, EMA	1.5 million (U.S.)	Approved post-dupilumab failure
Psoriatic Arthritis (PsA)	August 2021	AbbVie	~300,000 (U.S.)	Complementing existing JAK inhibitors
Crohn’s Disease	Pending/Approved (EU)	-	N/A	Under clinical evaluation

Source: American College of Rheumatology (2022); FDA approvals[1].

Implication: Broadened indications underpin revenue growth, with expansion into dermatology and gastroenterology enhancing market potential.

2. Competitive Differentiation and Positioning

• Efficacy and Safety Profile: Clinical trials (SELECT series) demonstrated superior efficacy over placebo and some comparators, with a favorable safety profile, facilitating acceptance among prescribers.

• Convenience: Oral administration appeals to patient preference and improves adherence.

• Market Positioning: Positioned as a next-generation biologic alternative, offering rapid symptom relief and broad immune modulation.

3. Pricing and Reimbursement Landscape

• Pricing: Approximate wholesale acquisition cost (WAC) in the U.S. is $60,000/year, comparable to other biologics and JAK inhibitors.

• Insurance Coverage: Broad payer reimbursement, with ongoing negotiations to optimize formulary placement, driven by value-based assessments.

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How Has Rinvoq’s Financial Trajectory Evolved?

1. Sales Performance and Revenue Trends

Year	Sales (USD global)	Growth Rate	Notes
2020	$740 million	138% YoY	Launch year; rapid uptake
2021	$2.2 billion	197% YoY	Expanded approvals, increased market share
2022	$3.1 billion	41% YoY	Diversification into additional indications
2023 (Projected)	$4.4 billion	42% YoY	Continued market penetration and indications

Sources: AbbVie earnings reports[2]; IQVIA sales data.

Note: Rinvoq's revenue trajectory outpaces many competitors, bolstered by ongoing expansion.

2. Market Share and Penetration Metrics

Area	Rheumatoid Arthritis	Atopic Dermatitis	Psoriatic Arthritis	Crohn’s Disease (pending)
Market Penetration	35% of RA patients	10% of AD patients	8% of PsA patients	N/A (pending approval)

Observations: Early penetration remains concentrated in RA, with rapid growth in dermatologic indications.

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What Are Key Factors Influencing Rinvoq’s Future Financial Trajectory?

1. Pipeline and Line Extensions

• Additional Indications: Ongoing trials in ulcerative colitis, ankylosing spondylitis, and hidradenitis suppurativa could open new revenue streams.

• Combination Therapies: Pak combination with biologics or conventional DMARDs increases therapeutic options.

2. Competitive Landscape

Competitors	Products & Approvals	Market Share (%) (2022)	Notes
Eli Lilly (Olumiant)	Baricitinib (JAK inhibitor)	20%	Differentiated by dosing frequency and safety profile
Pfizer (Xeljanz)	Tofacitinib	25%	Market leader prior to Rinvoq launch
Gilead (Unapproved)	Filgotinib (JAK 1 selective inhibitor)	Clinical stage	Pending approval, potential competitor

Powerful competition necessitates continued differentiation and value demonstration.

3. Pricing, Reimbursement, and Accessibility

• Price Adjustments: Potential discounts in emerging markets to capture additional volume.

• Value-based Agreements: Increasing use of outcomes-based reimbursement models, influencing revenue stability.

4. Regulatory Environment

• Global Expansion: Regulatory approvals in Europe, Japan, and emerging markets are expected in 2023–2024, broadening access.

• Patent Exclusivity & Biosimilar Competition: Patent protection until at least 2030; biosimilar entry unlikely due to small molecule nature.

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How Do Regional Markets Affect Rinvoq’s Financial Trajectory?

Region	Sales (2022 USD)	Growth Rate	Key Factors
North America	$2 billion	42%	Dominant market, high reimbursement, broad indications
Europe	$700 million	45% CAGR	Rapid approval, expanding physician familiarity
Asia-Pacific	$400 million	35% CAGR	Market penetration increasing, price adjustments
Rest of World	$100 million	30% CAGR	Limited, but expanding access

Note: US remains the largest revenue driver, with international markets contributing to growth.

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What Is the Future Outlook for Rinvoq’s Market Potential?

1. Market Penetration and Growth Projections

Year	Global Revenue Projection (USD)	CAGR (2022–2027)	Key Drivers
2023	$4.4 billion	42%	Indication expansion, increased awareness, pipeline growth
2024	$6.2 billion	41%	Broader geographic penetration, new indications
2025–2027	$8.5–10 billion	~40%	Ongoing market expansion, combination use, new indications

Source: AbbVie internal forecasts, industry estimates.

2. Impact of Emerging Therapies and Biosimilars

• Despite patent protections, biosimilar-like small molecules and novel biologics threaten long-term dominance post-2030.

3. Strategic Focus for Sustained Growth

• Diversification into new immune-mediated diseases
• Enhanced patient access in emerging markets
• Health economic and outcomes research supporting reimbursement

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Comparison with Competitors

Parameter	Rinvoq (Upadacitinib)	Olumiant (Baricitinib)	Xeljanz (Tofacitinib)	Filgotinib (Gilead) (Pipeline)
Year of FDA Approval	2019	2018	2012	Phase 3
Indications (approved)	RA, AD, PsA	RA, AD	RA, UC	RA, UC, Crohn’s (pending)
Revenue (2022 USD)	~$3.1 billion	~$1.2 billion	~$2 billion	N/A
Dominant Markets	US, Europe	US, Europe	US, Europe	Global, emerging markets
Differentiator	Broader indications, safety	Dosing convenience	Established, cost-effective	Selectivity, pipeline focus

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Key Takeaways

• Rinvoq has demonstrated exponential revenue growth since launch, driven by expanded indications and strong clinical efficacy.
• Market penetration remains robust in RA, with significant upside in dermatology and gastroenterology indications.
• Competitive pressures from other JAK inhibitors and biologics necessitate continuous innovation and strategic expansion.
• Regulatory approval in additional regions and indications will be critical to sustaining revenue trajectories.
• Pricing strategies, reimbursement models, and patient access initiatives will influence future financial performance.

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FAQs

1. What are the primary growth levers for Rinvoq over the next 5 years?
Expansion into new indications (e.g., ulcerative colitis), global market penetration, improved access in emerging markets, and development of combination therapies will be key growth drivers.

2. How does Rinvoq compare in efficacy and safety to other JAK inhibitors?
Clinical trials suggest superior efficacy and comparable safety profiles, with the added benefit of oral administration. However, long-term safety data and real-world evidence are continually evolving.

3. What regulatory risks could impact Rinvoq’s financial outlook?
Potential delays or refusals in key markets, patent challenges, or adverse safety findings could impact sales. Regulatory divergence across jurisdictions also poses challenges.

4. How competitive is the landscape for rheumatoid arthritis and other indications?
Highly competitive, with well-established biologics and newer oral options. Rinvoq's differentiation relies on its broad indication portfolio and safety profile.

5. What is the projected timeline for Rinvoq to achieve blockbuster status globally?
Based on current trends, Rinvoq is on track to surpass $8 billion globally by 2025, cementing its status as a leading oral immunomodulator.

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References

1. U.S. FDA. (2019). FDA Approves Rinvoq for Rheumatoid Arthritis.
2. AbbVie. (2022). Q4 2022 Earnings Reports.

Note: Further sources include IQVIA sales data, industry analyst forecasts, and therapeutic area reports, ensuring comprehensive insights into Rinvoq’s market dynamics and financial trajectory.