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Last Updated: February 9, 2023

Upadacitinib - Generic Drug Details


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

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

Upadacitinib has one hundred and sixty-two patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for upadacitinib
International Patents:162
US Patents:17
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 48
Patent Applications: 659
What excipients (inactive ingredients) are in upadacitinib?upadacitinib excipients list
DailyMed Link:upadacitinib at DailyMed
Recent Clinical Trials for upadacitinib

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

SponsorPhase
Lady Davis InstituteN/A
Montreal General HospitalN/A
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 4

See all upadacitinib clinical trials

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 Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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. 
Authorised no no no 2019-12-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for upadacitinib

Country Patent Number Title Estimated Expiration
European Patent Office 3362455 PROCÉDÉ DE PRÉPARATION DE (3S,4R)-3-ÉTHYL-4-(3H-IMIDAZO[1,2-A]PYRROLO[2,3-E]-PYRAZIN-8-YL)-N-(2,2,2-TRIFLUOROÉTHYL)PYRROLIDINE-1-CARBOXAMIDE ET DE SES FORMES À L'ÉTAT SOLIDE (PROCESSES FOR THE PREPARATION 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 FORMS THEREOF) See Plans and Pricing
Costa Rica 20160007 NUEVOS COMPUESTOS TRICICLICOS See Plans and Pricing
Dominican Republic P2013000055 NUEVOS COMPUESTOS TRICÍCLICOS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009152133 See Plans and Pricing
Russian Federation 2711869 Имидазопирролопиразиновые производные, полезные для лечения заболеваний, вызванных аномальной активностью протеинкиназ Jak1, Jak3 или Syk (IMIDAZOPYRROLOPYRINE DERIVATIVES USEFUL FOR TREATING DISEASES CAUSED BY ABNORMAL ACTIVITY OF PROTEIN KINASES JAK1, JAK3 OR SYK) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for upadacitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506716 C20200006 00317 Estonia See Plans and Pricing PRODUCT NAME: UPADATSITINIIB;REG NO/DATE: EU/1/19/1404; 18.12.2019
2506716 C202030012 Spain See Plans and Pricing 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 LUC00149 Luxembourg See Plans and Pricing PRODUCT NAME: UPADACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716 PA2020505,C2506716 Lithuania See Plans and Pricing PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716 122020000011 Germany See Plans and Pricing PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 20191216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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