Upadacitinib - Generic Drug Details

What are the generic drug sources for upadacitinib and what is the scope of freedom to operate?

Upadacitinib is the generic ingredient in two branded drugs marketed by Abbvie and is included in two NDAs. There are forty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Upadacitinib has one hundred and eighty-eight patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for upadacitinib

International Patents:	188
US Patents:	40
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	55
Patent Applications:	632
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for upadacitinib
What excipients (inactive ingredients) are in upadacitinib?	upadacitinib excipients list
DailyMed Link:	upadacitinib at DailyMed

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

Dosage:

TABLET, EXTENDED RELEASE;ORAL

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 upadacitinib

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

Sponsor	Phase
Sixth Affiliated Hospital, Sun Yat-sen University	N/A
Marie Hudson, MD	N/A
Lady Davis Institute	N/A

See all upadacitinib clinical trials

Pharmacology for upadacitinib

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for upadacitinib

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for UPADACITINIB

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 upadacitinib

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			Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes				Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes				Y
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes

EU/EMA Drug Approvals for upadacitinib

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 upadacitinib

Country	Patent Number	Title	Estimated Expiration
South Africa	201008562	NOVEL TRICYCLIC COMPOUNDS
Norway	20101688	Nye trisykliske forbindelser
Portugal	2299821
Singapore	10201913990R
Singapore	10201913986Y

Supplementary Protection Certificates for upadacitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	2020C/505	Belgium		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716	2020006	Norway		PRODUCT NAME: UPADACITINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/19/1404 20200103
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
2506716	C20200006 00317	Estonia		PRODUCT NAME: UPADATSITINIIB;REG NO/DATE: EU/1/19/1404; 18.12.2019
2506716	301035	Netherlands		PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1404 20191218

Upadacitinib Market Analysis and Financial Projection Experimental

Upadacitinib: A Rising Star in the Pharmaceutical Industry

Introduction

Upadacitinib, a novel Janus kinase (JAK) inhibitor, has been making significant waves in the pharmaceutical industry, particularly in the treatment of autoimmune diseases. This article delves into the market dynamics, financial trajectory, and future prospects of upadacitinib, highlighting its potential as a cornerstone in the management of autoimmune conditions.

What is Upadacitinib?

Upadacitinib is an oral JAK inhibitor primarily designed to treat moderate to severe rheumatoid arthritis (RA). It works by selectively inhibiting Janus kinase 1 (JAK1), an enzyme crucial in the inflammatory process, thereby reducing inflammation and preventing further joint damage[1].

Market Trends and Growth

The market for upadacitinib is experiencing rapid growth, driven by several key factors:

Rising Incidence of Autoimmune Diseases

The increasing prevalence of autoimmune diseases such as rheumatoid arthritis, psoriasis, and ulcerative colitis is a significant driver. As these conditions become more common, the demand for effective treatments like upadacitinib rises[1].

Advancements in Drug Development

Continuous research and development are expanding the therapeutic applications of upadacitinib. New indications and combination therapies are being explored, further boosting its market potential[1].

Increased Patient Awareness

Patients are becoming more informed about treatment options, leading to a growing preference for targeted therapies like upadacitinib due to their efficacy and tailored approach[1].

FDA Approval and Market Entry

Upadacitinib was approved by the FDA in 2019 as the third JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis. This approval marked a significant milestone, positioning upadacitinib as a competitive alternative to injectable TNF inhibitor biologics like adalimumab (Humira)[2].

Competitive Landscape

The market for JAK inhibitors is increasingly crowded, with competitors like tofacitinib (Xeljanz, Pfizer) and baricitinib (Olumiant, Eli Lilly). The potential expedited approval of filgotinib by Gilead Sciences adds another layer of competition, which could impact the market share of upadacitinib[2].

Financial Trajectory

Market Size and Projection

The global market for JAK inhibitors, including upadacitinib, is projected to reach several billion dollars by the mid-2020s. Upadacitinib's market size is expected to grow substantially, driven by its expanding approval for additional indications and high efficacy in treating existing conditions[1].

Investment Opportunities

Investing in upadacitinib offers several advantages, including potential gains from the drug’s growing market presence, new indications, and ongoing research. The expanding therapeutic applications and positive clinical outcomes make upadacitinib a promising investment in the pharmaceutical sector[1].

Cost-Effectiveness

According to ICER's economic modeling, upadacitinib plus a conventional disease-modifying antirheumatic drug (cDMARD) achieves marginally higher quality of life compared to adalimumab plus a cDMARD, at similar costs. This suggests that upadacitinib is cost-effective, with a value-based price benchmark range between $44,000 and $45,000, representing a 25% discount off its annual list price[5].

Clinical Efficacy and Safety

Clinical Trials

Upadacitinib has shown significant improvements in symptoms and disease activity in clinical trials for patients with RA and other autoimmune conditions. Long-term treatment with upadacitinib in adolescents with moderate to severe atopic dermatitis has also demonstrated a favorable benefit-risk profile[1][4].

Adverse Events

The adverse event profile of upadacitinib includes herpetic infections and creatine kinase elevation, but no new signals have been observed in long-term studies. This profile is consistent with the known risks associated with JAK inhibitors[4].

Future Prospects

Expanding Indications

Upadacitinib is being studied for its effectiveness in other autoimmune conditions beyond rheumatoid arthritis, such as psoriasis and ulcerative colitis. This expansion of indications is expected to further boost its market potential[1].

Strategic Partnerships and Innovations

Strategic partnerships and acquisitions in the pharmaceutical sector, along with the development of combination therapies, are enhancing the market potential of upadacitinib. These innovations are likely to keep upadacitinib at the forefront of autoimmune disease management[1].

Challenges and Risks

Competition and Regulatory Hurdles

Despite its potential, upadacitinib faces challenges from other JAK inhibitors and potential regulatory hurdles. However, its continued innovation and the expanding market for autoimmune disease treatments are expected to mitigate these risks[1].

Key Takeaways

• Rapid Market Growth: Driven by increasing prevalence of autoimmune diseases, advancements in drug development, and rising patient awareness.
• Clinical Efficacy: Upadacitinib has shown significant improvements in symptoms and disease activity in clinical trials.
• Cost-Effectiveness: Achieves marginally higher quality of life compared to adalimumab at similar costs.
• Expanding Indications: Being studied for effectiveness in other autoimmune conditions.
• Investment Opportunities: Promising investment due to growing market presence, new indications, and ongoing research.

FAQs

What is upadacitinib used for?

Upadacitinib is primarily used to treat moderate to severe rheumatoid arthritis and is being studied for its effectiveness in other autoimmune conditions like psoriasis and ulcerative colitis[1].

How does upadacitinib work?

Upadacitinib works by selectively inhibiting Janus kinase 1 (JAK1), an enzyme involved in the inflammatory process, thereby reducing inflammation and preventing further joint damage[1].

What are the potential side effects of upadacitinib?

The adverse event profile of upadacitinib includes herpetic infections and creatine kinase elevation, but no new signals have been observed in long-term studies[4].

Is upadacitinib cost-effective?

Yes, according to ICER's economic modeling, upadacitinib plus a cDMARD achieves marginally higher quality of life compared to adalimumab plus a cDMARD at similar costs[5].

What are the future prospects for upadacitinib?

Upadacitinib is expected to become a cornerstone in the treatment of various autoimmune diseases, with ongoing research and an expanding range of indications contributing to its market growth[1].

Sources

1. Market Research Intellect: "Upadacitinib Market Size And Projection - Market Research Intellect"
2. Healio: "Arthritis drug market rattles as upadacitinib wins race to FDA approval"
3. Cognitive Market Research: "Global Upadacitinib Market Report 2024 Edition"
4. JAMA Dermatology: "Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis"
5. ICER: "ICER Issues Final Report and Policy Recommendations on JAK Inhibitors for Rheumatoid Arthritis"