rinvoq Drug Patent Profile

When do Rinvoq patents expire, and when can generic versions of Rinvoq launch?

Rinvoq is a drug marketed by Abbvie and is included in two NDAs. There are forty-four patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Generic Entry Outlook for Rinvoq

Rinvoq 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

International Patents:	223
US Patents:	44
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	42
Patent Applications:	1,347
Drug Prices:	Drug price information for rinvoq
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rinvoq
What excipients (inactive ingredients) are in rinvoq?	rinvoq excipients list
DailyMed Link:	rinvoq at DailyMed

See drug prices for rinvoq

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

Constraining patent/regulatory exclusivity:

9,951,080

NDA:

211675

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 rinvoq

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

Sponsor	Phase
Berinstein, Jeffrey	PHASE4
AbbVie	PHASE4
AbbVie	PHASE3

See all rinvoq clinical trials

Pharmacology for rinvoq

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for RINVOQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RINVOQ	Extended-release Tablets	upadacitinib	45 mg	211675	3	2023-08-16

US Patents and Regulatory Information for rinvoq

rinvoq is protected by sixty US patents and five 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	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No	11,680,069		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes	11,773,105		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	10,981,924		Y

EU/EMA Drug Approvals for rinvoq

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

When does loss-of-exclusivity occur for rinvoq?

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2022107001
World Intellectual Property Organization (WIPO)	2021067465
World Intellectual Property Organization (WIPO)	2023059703

Supplementary Protection Certificates for rinvoq

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	C20200006 00317	Estonia		PRODUCT NAME: UPADATSITINIIB;REG NO/DATE: EU/1/19/1404; 18.12.2019
2506716	C02506716/01	Switzerland		PRODUCT NAME: UPADACITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67257 20.01.2020
2506716	2020C/505	Belgium		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218

RINVOQ (Upadacitinib): Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

RINVOQ (upadacitinib), a selective Janus kinase 1 (JAK1) inhibitor developed by AbbVie, has established a significant presence in the treatment of inflammatory diseases. Its market trajectory is shaped by approved indications, clinical trial advancements, patent landscape, and competitive positioning within the broader JAK inhibitor class and other therapeutic modalities.

What is RINVOQ's Current Market Position?

RINVOQ is approved across multiple indications, demonstrating a broad therapeutic utility. As of late 2023, key approved indications include:

• Rheumatoid Arthritis (RA): Moderate to severe RA in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). This was one of the initial and most significant approvals.
• Psoriatic Arthritis (PsA): Active PsA in adults who have had an inadequate response or intolerance to one or more DMARDs.
• Ankylosing Spondylitis (AS): Active AS in adults who have had an inadequate response or intolerance to one or more DMARDs.
• Atopic Dermatitis (AD): Moderate to severe AD in adults and for patients 12 years of age and older whose disease is not adequately controlled by other pharmacologic treatments, or when those treatments are not advisable.
• Ulcerative Colitis (UC): Moderately to severely active UC in adults who have had an inadequate response, lost response, or were intolerant to at least one conventional therapy or a biologic.
• Crohn's Disease (CD): Moderately to severely active CD in adults who have had an inadequate response, lost response, or were intolerant to at least one conventional therapy or a biologic.

These approvals position RINVOQ as a multi-indication therapy, allowing for a wider patient reach and a more diversified revenue stream for AbbVie. The drug competes in a crowded therapeutic space, particularly with other JAK inhibitors and biologic agents.

What is the Competitive Landscape for RINVOQ?

RINVOQ operates within a competitive environment, primarily against other JAK inhibitors and established biologic therapies.

JAK Inhibitor Competition:

The JAK inhibitor market is characterized by multiple players targeting different JAK isoforms.

• Xeljanz (tofacitinib) by Pfizer: The first JAK inhibitor approved for RA. It targets JAK1, JAK2, and JAK3. While a pioneer, it faces a more extensive safety profile discussion compared to newer, more selective agents.
• Olumiant (baricitinib) by Eli Lilly: A selective JAK1 and JAK2 inhibitor. It has indications in RA and alopecia areata. Its safety profile has also been subject to scrutiny and label updates.
• Jyseleca (filgotinib) by Gilead Sciences: A selective JAK1 inhibitor. Its development and commercialization have faced setbacks, particularly in the US, due to safety concerns raised by regulatory bodies like the FDA. It has achieved approvals in Europe and Japan for RA.
• Abrocitinib (Cibinqo) by Pfizer: A selective JAK1 inhibitor approved for atopic dermatitis. It directly competes with RINVOQ in this indication.

Biologic Therapy Competition:

Biologics remain a cornerstone of treatment for many inflammatory conditions, presenting a significant competitive force.

• TNF Inhibitors: Drugs like adalimumab (Humira), etanercept (Enbrel), and infliximab (Remicade) are long-established and widely used for RA, PsA, AS, and IBD.
• IL-17 Inhibitors: Secukinumab (Cosentyx) and ixekizumab (Taltz) are highly effective in PsA, AS, and AD.
• IL-23 Inhibitors: Guselkumab (Tremfya) and risankizumab (Skyrizi) are potent agents for PsA, AS, and IBD, with risankizumab also approved for AD.
• IL-6 Inhibitors: Tocilizumab (Actemra) is a significant competitor in RA.

RINVOQ's competitive advantage lies in its selective JAK1 inhibition, aiming for a differentiated efficacy and safety profile compared to less selective JAKs. Its multi-indication approvals also provide a strategic advantage in capturing a broader market share. However, the established efficacy and familiar safety profiles of biologics, along with evolving safety communications for all JAK inhibitors, represent ongoing challenges.

What is the Patent and Exclusivity Landscape for RINVOQ?

The patent and exclusivity landscape for RINVOQ is critical for its long-term financial trajectory. AbbVie holds a portfolio of patents protecting the compound, its synthesis, formulations, and methods of use.

• Composition of Matter Patents: These are fundamental and typically provide the longest period of exclusivity. The primary composition of matter patent for upadacitinib is expected to expire in the United States in 2034 [1].
• Method of Use Patents: These patents cover specific indications and dosing regimens. AbbVie has pursued and obtained numerous method of use patents for each approved indication. These patents are crucial for extending market exclusivity for specific therapeutic areas. For example, patents related to the treatment of rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease will have varying expiration dates.
• Formulation Patents: Patents covering specific salt forms, polymorphs, or extended-release formulations can also provide additional layers of protection.
• Regulatory Exclusivity: In addition to patent protection, RINVOQ benefits from statutory market exclusivities granted by regulatory agencies like the FDA and EMA upon approval of new drug applications (NDAs) and for new indications. These exclusivities can range from 5 years (for NDAs) to 7 years (for orphan drugs) or 12 years (for biologics in the US, though RINVOQ is a small molecule), and potentially longer for pediatric exclusivity or new chemical entity status.

Key Expiration Dates to Monitor:

While the core composition of matter patent is key, the expiration of method of use patents is critical for market entry of generics for specific indications. Generics for RA indications, for instance, might become available once relevant method of use patents expire, even if the composition of matter patent is still in force.

• United States: The primary composition of matter patent for upadacitinib is projected to expire in 2034. However, AbbVie has secured numerous method-of-use patents, many of which are expected to expire in the late 2030s and early 2040s [2].
• Europe: Patent protection for upadacitinib in Europe varies by country due to the unitary patent system and national validations. Supplementary Protection Certificates (SPCs) extend patent term based on the time taken for marketing authorization. The core patent protections are generally expected to expire in the mid-to-late 2030s, with SPCs potentially extending this period.

The strategic management of this patent portfolio, including potential litigation and settlements, will be a determining factor in the timing of generic competition and the ultimate profitability of RINVOQ.

What is RINVOQ's Financial Performance and Outlook?

RINVOQ has demonstrated strong sales growth since its launch, driven by its expanding label and physician/patient adoption.

Historical Sales Performance:

• 2020: RINVOQ (launched late 2019) generated \$277 million in net revenue.
• 2021: Sales increased to \$1.79 billion.
• 2022: Sales grew to \$2.56 billion [3].
• First Nine Months of 2023: Net revenue reached \$2.33 billion [4].

AbbVie's guidance indicates continued strong growth. The company has projected RINVOQ sales to exceed \$7 billion annually by 2027, with potential to reach over \$11 billion by 2029-2030, becoming a significant growth driver alongside Skyrizi (risankizumab) [5]. This projection is contingent on continued market penetration across its approved indications and successful launch in additional therapeutic areas and geographies.

Factors Influencing Future Financial Trajectory:

• Expansion into New Indications: Approval in new therapeutic areas, particularly major markets like atopic dermatitis, inflammatory bowel disease (Crohn's and Ulcerative Colitis), and ankylosing spondylitis, has been a key driver of growth. Further indications could enhance this trajectory.
• Geographic Expansion: Continued global rollout and market access in emerging markets will contribute to revenue growth.
• Competitive Pressures: The market entry of biosimil and generic competitors will eventually impact sales, though this is largely dependent on patent expiry dates and the strength of patent challenges.
• Safety and Efficacy Data: Ongoing real-world evidence and post-marketing surveillance data regarding RINVOQ's safety and efficacy profile will influence prescriber confidence and patient utilization. Label updates or new safety warnings could negatively impact sales.
• Pricing and Reimbursement: Negotiations with payers and the impact of healthcare policy changes on drug pricing will play a role in its financial performance.

The financial outlook for RINVOQ is robust in the medium term, with significant growth potential supported by its established and expanding therapeutic reach. The long-term outlook will be increasingly shaped by the patent cliff and the emergence of generic alternatives.

What are the Key Clinical Development Pathways for RINVOQ?

AbbVie continues to invest in the clinical development of RINVOQ, seeking to expand its indications and solidify its position in existing markets.

Ongoing and Planned Clinical Trials:

• Inflammatory Bowel Disease (IBD): Extensive clinical programs have led to approvals in ulcerative colitis and Crohn's disease. Further trials may explore maintenance therapy, different patient populations, or combination therapies.
• Atopic Dermatitis (AD): Trials have supported approvals in adult and adolescent populations. Further studies may investigate its efficacy in younger pediatric groups or in combination with topical treatments.
• Rheumatoid Arthritis (RA): While well-established, AbbVie has conducted and may continue to conduct trials to explore RINVOQ in earlier lines of therapy, in specific patient subgroups, or in comparison to other treatment modalities.
• Axial Spondyloarthritis (axSpA): Beyond ankylosing spondylitis, trials may explore other forms of axial spondyloarthritis.
• Dermatomyositis: Clinical trials are underway to evaluate RINVOQ's efficacy in dermatomyositis, a rare autoimmune disease affecting muscles and skin.
• Systemic Lupus Erythematosus (SLE): RINVOQ is being investigated in clinical trials for SLE, a chronic autoimmune disease that can affect various parts of the body.
• Giant Cell Arteritis (GCA): AbbVie has pursued clinical development for GCA, a form of vasculitis.

The success of these ongoing clinical trials is paramount for RINVOQ's future market growth. Positive results leading to new approvals will expand its addressable market and revenue potential. Conversely, trial failures or safety signals could curtail its trajectory.

Key Takeaways

• RINVOQ is a multi-indication JAK1 inhibitor with established approvals in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Crohn's disease.
• The drug faces competition from other JAK inhibitors (Xeljanz, Olumiant, Cibinqo) and a wide range of established biologic therapies.
• Key composition of matter patents are set to expire in the US in 2034, with method of use patents extending exclusivity for specific indications into the late 2030s and early 2040s.
• RINVOQ has experienced rapid sales growth, reaching over \$2.5 billion in 2022 and projected to exceed \$7 billion annually by 2027.
• Ongoing clinical development is focused on expanding indications in areas such as dermatomyositis, systemic lupus erythematosus, and evaluating its use in juvenile populations.

Frequently Asked Questions

1. What is the primary mechanism of action for RINVOQ? RINVOQ is a selective Janus kinase 1 (JAK1) inhibitor. It works by blocking the activity of JAK1 enzymes, which are involved in signaling pathways that trigger inflammation and immune responses in the body.

2. Which therapeutic areas have seen the most significant uptake for RINVOQ? Rheumatoid arthritis and atopic dermatitis have been key drivers of RINVOQ's initial uptake. More recently, the approvals in inflammatory bowel diseases (ulcerative colitis and Crohn's disease) are contributing substantially to its market penetration.

3. What are the main safety concerns associated with JAK inhibitors like RINVOQ? Regulatory bodies have highlighted potential safety risks associated with the JAK inhibitor class, including increased risk of serious infections, thrombosis, malignancy, and cardiovascular events. These concerns have led to updated labeling and prescribing information for drugs in this class.

4. How does RINVOQ differentiate itself from other JAK inhibitors? RINVOQ differentiates itself through its selective inhibition of JAK1. This selectivity is intended to provide efficacy while potentially mitigating some of the side effects associated with non-selective JAK inhibitors that target JAK1, JAK2, and JAK3.

5. When can generic versions of RINVOQ be expected to enter the market? While the exact timing of generic entry is subject to patent litigation outcomes, the core composition of matter patents in the US are expected to expire around 2034. Generic entry for specific indications may occur earlier if method of use patents expire sooner.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book Website]

[2] Pharmaceutical industry patent databases and analyses (e.g., Clarivate Analytics, LexisNexis). Specific patent numbers and expiration dates are proprietary and subject to change based on legal challenges.

[3] AbbVie Inc. (2023). Annual Report [Form 10-K]. U.S. Securities and Exchange Commission.

[4] AbbVie Inc. (2023). Quarterly Report [Form 10-Q] for the period ended September 30, 2023. U.S. Securities and Exchange Commission.

[5] AbbVie Investor Relations. (2023). Investor Presentations and Earnings Call Transcripts.