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 ten patents protecting this drug.

This drug has one hundred and seventy-nine 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 two 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 is one tentative approval for the generic drug (upadacitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for RINVOQ LQ

International Patents:	179
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	39
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
Berinstein, Jeffrey	Phase 4
Ottawa Hospital Research Institute	Phase 4
University of Ottawa	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 eleven 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				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
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

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/004760 Rheumatoid 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
Argentina	114947	COMPUESTOS TRICÍCLICOS
Japan	2022107001	（３Ｓ，４Ｒ）－３－エチル－４－（３Ｈ－イミダゾ［１，２－ａ］ピロロ［２，３－ｅ］－ピラジン－８－イル）－Ｎ－（２，２，２－トリフルオロエチル）ピロリジン－１－カルボキサミドおよびそれの固体型の製造方法
Peru	20121336	NUEVOS COMPUESTOS TRICICLICOS
Poland	2506716
Ukraine	112624	ТРИЦИКЛІЧНІ СПОЛУКИ

Supplementary Protection Certificates for RINVOQ LQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	20C1009	France		PRODUCT NAME: UPADACITINIB OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1404 20191218
2506716	C202030012	Spain		PRODUCT NAME: UPADACITINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1404; DATE OF AUTHORISATION: 20191216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1404; DATE OF FIRST AUTHORISATION IN EEA: 20191216
2506716	CR 2020 00011	Denmark		PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716	SPC/GB20/012	United Kingdom		PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/19/1404(FOR NI) 20191218; UK PLGB41042/0042 20191218; UK PLGB41042/0087 20191218

Market Dynamics and Financial Trajectory for Rinvoq (Upadacitinib)

Introduction

Rinvoq, also known as upadacitinib, is a Janus kinase (JAK) inhibitor developed by AbbVie, primarily used for the treatment of moderately to severely active rheumatoid arthritis (RA) and other conditions such as active polyarticular juvenile idiopathic arthritis (pJIA). Here, we delve into the market dynamics and financial trajectory of Rinvoq.

Market Authorization and Clinical Efficacy

Rinvoq was authorized by Health Canada and other regulatory bodies based on extensive clinical trials that demonstrated its efficacy and safety profile. The drug has shown significant clinical benefits in patients with RA, particularly those who have had an inadequate response or intolerance to methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)[1].

Market Positioning

Rinvoq is part of AbbVie's immunology portfolio, which also includes other successful drugs like Humira and Skyrizi. The market positioning of Rinvoq is strong, given its effectiveness as both a monotherapy and in combination with other DMARDs. This versatility has helped it gain traction in the competitive RA treatment market[1].

Financial Performance

The financial performance of Rinvoq has been impressive, reflecting its growing market share and acceptance.

Global Net Revenues

In 2023, global net revenues for Rinvoq were $1.255 billion, representing a significant increase of 62.9% on a reported basis and 62.8% on an operational basis compared to the previous year. This growth underscores the drug's increasing popularity and market penetration[3].

Revenue Projections

AbbVie has raised its long-term outlook for Rinvoq, anticipating combined revenues for Skyrizi and Rinvoq to exceed $27 billion by 2027. This projection indicates a high level of confidence in the drug's continued market success and growth potential[3].

Economic Evaluation

The economic evaluation of Rinvoq has been favorable, particularly from a public health care payer perspective. Studies have shown that the drug offers significant quality-adjusted life years (QALYs) over a long time horizon, making it a cost-effective option despite its higher acquisition costs. The economic model used to evaluate Rinvoq considered various costs, including drug acquisition, administration, monitoring, and direct medical costs, as well as adverse events[2].

Competitive Landscape

The RA treatment market is highly competitive, with several biologic and non-biologic DMARDs available. However, Rinvoq's unique profile as a JAK inhibitor sets it apart. It competes directly with other JAK inhibitors and biologic DMARDs but has shown superior efficacy in some clinical trials. The recent biosimilar competition to Humira has also created an opportunity for Rinvoq to capture a larger market share within AbbVie's immunology portfolio[3].

Side Effects and Safety Considerations

While Rinvoq has demonstrated strong efficacy, it also comes with significant safety considerations. The drug is associated with higher rates of major adverse cardiovascular events (MACE), malignancies, and thrombosis compared to tumor necrosis factor (TNF) blockers. These risks necessitate careful patient monitoring and have implications for its long-term market acceptance and regulatory oversight[5].

Pricing and Accessibility

The cost of Rinvoq can vary based on insurance plans, location, and pharmacy. Despite its higher cost, the drug's effectiveness and the potential for improved quality of life for patients make it a valuable option for many. However, the cost remains a barrier for some patients, highlighting the need for continued efforts to improve accessibility[4].

Future Outlook

AbbVie's long-term outlook for Rinvoq is optimistic, with expectations of high single-digit compound annual revenue growth through 2029. The company's strategic acquisitions and pipeline enhancements are also expected to support the growth of its immunology portfolio, including Rinvoq. As the drug continues to gain market share and expand its indications, it is likely to remain a significant contributor to AbbVie's financial performance[3].

Key Takeaways

• Strong Clinical Efficacy: Rinvoq has demonstrated significant clinical benefits in treating RA and other conditions.
• Impressive Financial Growth: The drug has seen substantial revenue growth and is projected to continue this trend.
• Competitive Market: Rinvoq competes in a highly competitive market but has carved out a unique position due to its efficacy and versatility.
• Safety Considerations: The drug is associated with several safety risks, necessitating careful patient monitoring.
• Future Outlook: AbbVie expects continued growth and expansion of Rinvoq's market presence.

FAQs

What is Rinvoq used for?

Rinvoq is primarily used for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) and also for active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older[5].

How effective is Rinvoq in treating RA?

Rinvoq has shown statistically significant improvements in clinical trials, with a high proportion of patients achieving ACR20, ACR50, and ACR70 responses. It is effective both as a monotherapy and in combination with methotrexate or other csDMARDs[1].

What are the major side effects of Rinvoq?

Rinvoq is associated with higher rates of major adverse cardiovascular events (MACE), malignancies, thrombosis, and serious infections. Patients must be closely monitored for these risks[5].

How much does Rinvoq cost?

The cost of Rinvoq varies based on insurance plans, location, and pharmacy. It is generally more expensive than some other treatment options but offers significant clinical benefits[4].

What is the long-term financial outlook for Rinvoq?

AbbVie expects Rinvoq to contribute significantly to its revenue growth, with combined revenues for Skyrizi and Rinvoq projected to exceed $27 billion by 2027. The company anticipates high single-digit compound annual revenue growth through 2029[3].

Sources

1. Health Canada: Summary Basis of Decision for Rinvoq.
2. NCBI Bookshelf: Pharmacoeconomic Review - Upadacitinib (Rinvoq).
3. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
4. Medical News Today: Rinvoq: Side effects, cost, uses, dosage, and more.
5. FDA: RINVOQ/RINVOQ LQ - Label.