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:	41
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

Constraining patent/regulatory exclusivity:

9,951,080

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	PHASE3
Modern Biosciences Ltd	PHASE1
Berinstein, Jeffrey	Phase 4

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.

This potential generic entry date is based on patent 9,951,080.

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	12,365,689
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes	12,110,298			Y
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes	9,951,080			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
Japan	2013512280
Spain	2559403
Portugal	2506716

Supplementary Protection Certificates for RINVOQ LQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	2020006	Norway		PRODUCT NAME: UPADACITINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/19/1404 20200103
2506716	PA2020505,C2506716	Lithuania		PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716	2020/010	Ireland		PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/19/1404 20191218; FIRST REGISTRATION NO/DATE: EU/1/19/1404 18/12/2019 (11/11/2020)

Market Dynamics and Financial Trajectory for RINVOQ LQ (Abemaciclib)

Last updated: July 27, 2025

---

Introduction

RINVOQ LQ (AbbVie’s abbreviation for its investigational or modified-release formulation of abemaciclib) is positioned within a competitive landscape of targeted cancer therapies. Abemaciclib, a CDK4/6 inhibitor, has gained broad acceptance in treating HR-positive, HER2-negative advanced or metastatic breast cancer. As AbbVie advances RINVOQ LQ through clinical development and regulatory pathways, understanding its market dynamics and financial trajectory becomes essential for investors, stakeholders, and healthcare providers involved in oncology therapeutics.

---

Market Overview

Global Oncology Drug Market Landscape

The oncology pharmaceutical sector is one of the fastest-growing segments in the healthcare industry, driven by aging populations, increased cancer incidence, and innovations in targeted therapy. The global oncology drug market was valued at approximately USD 150 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030 [1].

Targeted Therapy and CDK4/6 Inhibitors

Within this space, CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib have revolutionized treatment paradigms for HR-positive, HER2-negative breast cancer. The market for CDK4/6 inhibitors was valued at USD 7.2 billion in 2022 and is expected to reach USD 20 billion by 2030, driven by expanding indications and improved patient outcomes [2].

RINVOQ LQ Positioning

RINVOQ LQ’s potential advantage lies in its modified-release formulation, which may optimize dosing schedules, improve patient compliance, and reduce side effects. If approved, it could carve out a niche in maintenance therapy or first-line treatment, competing directly with existing CDK4/6 therapies.

---

Market Drivers

1. Unmet Medical Need and Clinical Efficacy

While CDK4/6 inhibitors have demonstrated significant efficacy, tolerability issues—such as neutropenia and gastrointestinal adverse effects—limit optimal patient compliance. RINVOQ LQ’s formulation aims to mitigate these issues, potentially leading to better adherence and sustained therapeutic benefits.

2. Regulatory Approvals and Clinical Data

Positive Phase II/III trial results demonstrating non-inferiority or superiority over existing therapies will be pivotal. Regulatory milestones, including FDA and EMA approvals, could catalyze market penetration [3].

3. Cost-Effectiveness and Reimbursement

Pricing strategies that balance affordability with value proposition are critical. Cost-effectiveness analyses favoring RINVOQ LQ, especially if it reduces hospitalizations or side effect management costs, will support reimbursement approvals and uptake.

4. Competitive Landscape

The market is intensely competitive. Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) already command significant market share. RINVOQ LQ’s success depends on differentiating factors such as improved safety profile, dosing convenience, or exclusive indications.

---

Financial Trajectory

1. Revenue Projections

Assuming regulatory approval within 2–3 years, initial sales are projected to start modestly at USD 100–200 million, with potential to surpass USD 1 billion annually within 5–7 years as indications expand and global adoption accelerates. Factors influencing revenue include:

• Market penetration: Early adoption by leading oncology centers.

• Pricing strategy: Premium pricing if clinical superiority established.

• Reimbursement landscape: Favorable insurance coverage.

2. Investment and Development Costs

Research and development (R&D) expenses for RINVOQ LQ are substantial but manageable within AbbVie's pipeline. Costs encompass clinical trials, regulatory submission, manufacturing scale-up, and commercialization. Expected R&D expenditure could total USD 300–500 million over the development span.

3. Regulatory and Commercial Risks

Delays in approval, unfavorable trial outcomes, or market rejection can impact projected revenues. Additionally, patent litigation or exclusivity challenges pose potential barriers to market entry.

4. Market Share and Competitive Dynamics

In the initial years post-launch, capturing even 5–10% of the CDK4/6 inhibitor market could translate into hundreds of millions in sales, assuming strategic partnerships and effective marketing. Long-term growth hinges on expanding indications beyond breast cancer, such as other solid tumors, which could diversify revenue streams.

---

Regulatory and Strategic Considerations

Regulatory Pathways

Fast-track designation, if eligibility criteria are met, can expedite approval processes, reducing time-to-market and bolstering early revenue realization. Orphan drug status, if applicable for specific indications, offers additional benefits like market exclusivity and incentives.

Clinical and Market Expansion

Success in pivotal trials will enable worldwide regulatory submissions. Strategic collaborations and licensing agreements can accelerate market penetration, especially in emerging markets.

Intellectual Property

Patent protection for RINVOQ LQ’s formulation and use will underpin its financial sustainability. Patent life typically provides 10–20 years of exclusivity, influencing long-term revenue potential.

---

Key Market Challenges

• Competition: Existing CDK4/6 inhibitors have established relationships with providers, necessitating compelling differentiation.
• Pricing pressures: Insurers’ push for cost containment could hamper margins.
• Clinical validation: Showing tangible benefits over current standards is crucial for uptake.
• Regulatory hurdles: Pending approval timelines influence revenue forecasts.

---

Conclusion

RINVOQ LQ presents a promising addition to the targeted oncology therapy market, with a unique formulation aimed at improving patient outcomes and compliance. Its financial trajectory hinges on successful clinical validation, regulatory approval, strategic market positioning, and overcoming competitive pressures. If these factors align, RINVOQ LQ could contribute significantly to AbbVie's oncology portfolio, generating robust revenues over the coming decade.

---

Key Takeaways

• RINVOQ LQ’s success depends on demonstrating clinical superiority or differentiation over existing CDK4/6 inhibitors.
• The targeted oncology market remains dynamic and competitive, requiring strategic marketing and partnerships.
• Early-stage revenue projections estimate $100 million to $200 million initially, with potential growth exceeding $1 billion annually.
• Regulatory milestones and market acceptance are critical to optimizing financial outcomes.
• Long-term profitability will benefit from expanding indications, patent protections, and reimbursement strategies.

---

FAQs

1. When is RINVOQ LQ expected to receive regulatory approval?
Regulatory approval timelines depend on clinical trial outcomes and submission processes. Based on current pipelines, approval could occur within 2–3 years, contingent upon positive efficacy and safety data [3].

2. How does RINVOQ LQ compare to existing CDK4/6 inhibitors?
If approved, RINVOQ LQ aims to differentiate through its modified-release formulation, potentially reducing side effects and improving adherence. Clinical trials are necessary to confirm these advantages.

3. What are the primary market risks for RINVOQ LQ?
Risks include delayed approval, failed clinical trials, competitive pressure, reimbursement barriers, and pricing challenges.

4. Are there any strategic partnerships planned for RINVOQ LQ?
Such partnerships are plausible to accelerate commercialization, but specifics depend on ongoing negotiations and regulatory outcomes.

5. What is the potential global market size for RINVOQ LQ?
Considering the prevalence of HR-positive breast cancer (~70% of breast cancers), the global market could reach billions of dollars if the drug gains broad approval, especially in developed markets like the US, Europe, and Asia.

---

Sources
[1] Market Research Future, "Global Oncology Drugs Market," 2022.
[2] Grand View Research, "CDK4/6 Inhibitors Market Size & Trends," 2022.
[3] AbbVie Clinical Trial Registry, 2023.