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

Constraining patent/regulatory exclusivity:

9,951,080

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

9,951,080

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
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

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	211675-001	Aug 16, 2019		RX	Yes	No
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	11,680,069		Y	Y
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes	9,951,080		Y	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
Taiwan	201002720	Novel tricyclic compounds
Russian Federation	2015144809	НОВЫЕ ТРИЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ
Russian Federation	2015105591	НОВЫЕ ТРИЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ
Canada	3123260	HEMIHYDRATE CRISTALLIN DE (3S,4R)-3-ETHYL-4-(3H-IMIDAZO[1,2-A]PYRROLO[2,3-E]PYRAZINE-8-YL)-N-(2,2,2-TRIFLUOROETHYL)PYRROLIDINE-1-CARBOXAMIDE ET FORME A L'ETAT SOLIDE (CRYSTALLINE HEMIHYDRATE OF (3S,4R)-3-ETHYL-4-(3H-IMIDAZO[1,2-A]PYRROLO[2,3-E]PYRAZIN-8-YL)-N-(2,2,2-TRIFLUOROETHYL)PYRROLIDINE-1-CARBOXAMIDE AND SOLID STATE FORM THEREOF)
South Korea	101785257

Supplementary Protection Certificates for upadacitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506716	2020006	Norway		PRODUCT NAME: UPADACITINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/19/1404 20200103
2506716	PA2020505,C2506716	Lithuania		PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716	2020/010	Ireland		PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/19/1404 20191218; FIRST REGISTRATION NO/DATE: EU/1/19/1404 18/12/2019 (11/11/2020)
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