UPADACITINIB - Generic Drug Details

What are the generic sources for upadacitinib and what is the scope of patent protection?

Upadacitinib is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are thirty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for UPADACITINIB

International Patents:	184
US Patents:	33
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	52
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

^*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
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4
McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A
Marie Hudson, MD	N/A

See all UPADACITINIB clinical trials

Pharmacology for UPADACITINIB

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

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	211675-001	Aug 16, 2019		RX	Yes	No
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes				Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No			Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No			Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No			Y	Y

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
European Patent Office	3266786	NOUVEAUX COMPOSÉS TRICYCLIQUES (NOVEL TRICYCLIC COMPOUNDS)
Brazil	112018007677	processos para a preparação de (3s,4r)-3-etil-4-(3h-imidazo[1,2-a]pirrolo[2,3-e]-pirazin-8-il)-n-(2,2,2-trifluoroetil)pirrolidina-1-carboxamida e suas formas em estado sólido
Cyprus	1117165
South Korea	20160148053	신규한 트리사이클릭 화합물 (Novel tricyclic compounds)
Taiwan	201434841	Novel tricyclic compounds
Russian Federation	2545023	ТРИЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ, СОДЕРЖАЩАЯ ИХ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И ИХ ПРИМЕНЕНИЕ ДЛЯ ЛЕЧЕНИЯ ИММУНОЛОГИЧЕСКИХ И ОНКОЛОГИЧЕСКИХ СОСТОЯНИЙ (TRICYCLIC COMPOUNDS, PHARMACEUTICAL COMPOSITION CONTAINING THEM AND USING THEM FOR TREATING IMMUNOLOGICAL AND ONCOLOGICAL COMPOUNDS)
South Korea	20110017431	NOVEL TRICYCLIC COMPOUNDS

Supplementary Protection Certificates for UPADACITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	2090010-6	Sweden		PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1404 20191218
2506716	CA 2020 00011	Denmark		PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716	PA2020505,C2506716	Lithuania		PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
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	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	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