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-three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-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 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

International Patents:	193
US Patents:	43
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	39
Patent Applications:	202
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	Phase 4
University of Ottawa	Phase 4
The Ottawa Hospital	Phase 4

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 fifty-seven US patents and seven 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	211675-001	Aug 16, 2019		RX	Yes	No	11,780,847		Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	11,198,697		Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No	11,661,425		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes	11,718,627		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes	8,962,629			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/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

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
China	116270646
Israel	261778	תרכובות טריציקליות חדשות (Novel tricyclic compounds)
Russian Federation	2018117889	СПОСОБЫ ПОЛУЧЕНИЯ (3S,4R)-3-ЭТИЛ-4-(3H-ИМИДАЗО[1,2-a]ПИРРОЛО[2,3-e]-ПИРАЗИН-8-ИЛ)-N-(2,2,2-ТРИФТОРЭТИЛ)ПИРРОЛИДИН-1-КАРБОКСАМИДА И ЕГО ТВЕРДОФАЗНЫХ ФОРМ
Ukraine	112624	ТРИЦИКЛІЧНІ СПОЛУКИ
World Intellectual Property Organization (WIPO)	2021067465

Supplementary Protection Certificates for RINVOQ

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	2020C/505	Belgium		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716	2090010-6	Sweden		PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1404 20191218
2506716	C20200006 00317	Estonia		PRODUCT NAME: UPADATSITINIIB;REG NO/DATE: EU/1/19/1404; 18.12.2019
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 the Drug: RINVOQ

Introduction to RINVOQ

RINVOQ, also known as upadacitinib, is a Janus kinase (JAK) inhibitor developed by AbbVie. It has been approved for several immunology indications, including moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

Approval and Indications

RINVOQ first received FDA approval in mid-2019 for the treatment of moderate to severe rheumatoid arthritis. Since then, it has been approved for multiple other immunology indications, expanding its market reach significantly[1][3].

Market Performance

Revenue Growth

RINVOQ has demonstrated robust revenue growth across its approved indications. In the third quarter of 2024, global net revenues for RINVOQ were $1.614 billion, representing a 45.3% increase on a reported basis and a 47.4% increase on an operational basis compared to the previous year[2][3].

Year-over-Year Growth

The drug's sales have been growing rapidly, with a year-over-year (YOY) growth rate of 43% in the rheumatoid arthritis market, making it the second largest driver of absolute growth in this segment, behind adalimumab (Humira)[1].

Market Share and Penetration

RINVOQ is capturing significant market share across its indications. For example, in the U.S., RINVOQ is now capturing double-digit in-play patient share for ulcerative colitis and Crohn’s disease. It is available in over 75 countries with increasing reimbursement and market share[3].

Key Indications and Market Impact

Rheumatoid Arthritis

In the rheumatoid arthritis market, RINVOQ is a major player, with its sales growing rapidly. It has been approved as a treatment for moderate to severe rheumatoid arthritis and has shown superiority over other treatments like Humira and Orencia in head-to-head studies[1][3].

Atopic Dermatitis

RINVOQ has also made significant strides in the atopic dermatitis market. Despite the dominance of Dupixent (dupilumab), RINVOQ has gained a license expansion for atopic dermatitis and is seeing an acceleration of in-play share following positive data from its second head-to-head study versus Dupixent[1][4].

Psoriasis and Other Indications

While psoriasis is a highly competitive market, RINVOQ is not as dominant here as it is in other indications. However, its sister drug, Skyrizi (risankizumab), is a major player in psoriasis, and together they contribute significantly to AbbVie's immunology portfolio[1][3].

Financial Projections and Outlook

Revenue Projections

AbbVie has raised its full-year sales guidance for RINVOQ multiple times due to its strong performance. The company now expects RINVOQ and Skyrizi combined to generate over $17 billion in sales, surpassing initial forecasts[3].

Long-Term Growth Prospects

The long-term growth prospects for RINVOQ are promising. AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s, driven by new indications and continued market penetration[3].

Market Forecast

According to market forecasts, RINVOQ's market size for atopic dermatitis alone is expected to grow substantially from 2022 to 2032, driven by extensive research and incremental healthcare spending globally[4].

Competitive Landscape

Differentiation and Head-to-Head Studies

RINVOQ's success is largely attributed to its strong differentiation and compelling head-to-head data against several novel therapies. It has shown superiority over Humira, Orencia, and Dupixent in various indications, which has been a key factor in its market success[3].

Emerging Competitors

The market for atopic dermatitis and other indications is expected to become more competitive with the launch of late-stage emerging therapies. However, RINVOQ's established position and ongoing research and development activities are expected to help it maintain its market dominance[4].

Regulatory and Developmental Activities

Regulatory Milestones

RINVOQ has achieved several regulatory milestones, including approvals for multiple indications. Ongoing studies and regulatory activities are expected to further expand its therapeutic portfolio[4].

Research and Development

AbbVie continues to invest in research and development for RINVOQ, including new head-to-head studies and expansion into new indications. This ongoing innovation is crucial for maintaining its competitive edge[3].

Financial Impact on AbbVie

Revenue Contribution

RINVOQ is a significant contributor to AbbVie's immunology portfolio, which saw global net revenues of $7.046 billion in the third quarter of 2024, an increase of 3.9% on a reported basis and 4.8% on an operational basis[2].

Earnings and Guidance

The strong performance of RINVOQ has led AbbVie to increase its full-year revenue and earnings guidance. Despite challenges from biosimilar competition to Humira, the growth of RINVOQ and other immunology products has been favorable for AbbVie's overall financial performance[2][3].

Conclusion

RINVOQ has established itself as a key player in the immunology market, driven by its rapid growth, strong differentiation, and expanding indications. With a robust financial trajectory and promising long-term growth prospects, RINVOQ is set to continue its dominance in the market.

Key Takeaways

• Rapid Revenue Growth: RINVOQ has shown significant revenue growth, with a 45.3% increase in the third quarter of 2024.
• Market Penetration: It has captured double-digit market share in several indications, including ulcerative colitis and Crohn’s disease.
• Competitive Edge: Strong head-to-head data against other therapies has been a key factor in its success.
• Long-Term Prospects: AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s.
• Regulatory and Developmental Activities: Ongoing studies and regulatory activities are expected to further expand its therapeutic portfolio.

FAQs

Q: What are the approved indications for RINVOQ?

RINVOQ is approved for moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

Q: How has RINVOQ performed in terms of revenue growth?

RINVOQ's global net revenues were $1.614 billion in the third quarter of 2024, representing a 45.3% increase on a reported basis and a 47.4% increase on an operational basis.

Q: What is the competitive landscape for RINVOQ in atopic dermatitis?

RINVOQ competes with Dupixent (dupilumab) in the atopic dermatitis market but has shown promising results in head-to-head studies, leading to an acceleration of its market share.

Q: What are the long-term growth prospects for RINVOQ?

AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s, driven by new indications and continued market penetration.

Q: How does RINVOQ contribute to AbbVie's financial performance?

RINVOQ is a significant contributor to AbbVie's immunology portfolio, which saw global net revenues of $7.046 billion in the third quarter of 2024, helping to offset declines in Humira sales due to biosimilar competition.

Sources

1. IQVIA: "Delving deeper into the immunology and respiratory markets - IQVIA"[1]
2. PR Newswire: "AbbVie Reports Third-Quarter 2024 Financial Results"[2]
3. Investing.com: "Earnings call: AbbVie raises outlook on strong Q3 performance"[3]
4. Research and Markets: "RINVOQ Market Drug Insight and Market Forecast - 2032"[4]
5. AbbVie Investors: "AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results"[5]