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Last Updated: February 29, 2024

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 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for upadacitinib
Generic Entry Date for upadacitinib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Montreal General HospitalN/A
Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaPhase 4
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A

See all upadacitinib clinical trials

Pharmacology for upadacitinib
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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. 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for upadacitinib

Country Patent Number Title Estimated Expiration
China 116270646 制备咪唑并[1,2-a]吡咯并[2,3-e]吡嗪类化合物及其固态形式的方法 (Method for preparing imidazo [1, 2-a] pyrrolo [2, 3-e] pyrazine compound and solid-state form thereof) ⤷  Try a Trial
New Zealand 600161 Novel tricyclic compounds ⤷  Try a Trial
Japan 2022107001 (3S,4R)-3-エチル-4-(3H-イミダゾ[1,2-a]ピロロ[2,3-e]-ピラジン-8-イル)-N-(2,2,2-トリフルオロエチル)ピロリジン-1-カルボキサミドおよびそれの固体型の製造方法 ⤷  Try a Trial
European Patent Office 3950692 NOUVEAUX COMPOSÉS TRICYCLIQUES (NOVEL TRICYCLIC COMPOUNDS) ⤷  Try a Trial
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) ⤷  Try a Trial
Japan 7358317 ⤷  Try a Trial
China 116270645 制备咪唑并[1,2-a]吡咯并[2,3-e]吡嗪类化合物及其固态形式的方法 (Method for preparing imidazo [1, 2-a] pyrrolo [2, 3-e] pyrazine compound and solid-state form thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for upadacitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506716 723 Finland ⤷  Try a Trial
2506716 CR 2020 00011 Denmark ⤷  Try a Trial PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716 12/2020 Austria ⤷  Try a Trial PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 (MITTEILUNG) 20191218
2506716 PA2020505,C2506716 Lithuania ⤷  Try a Trial PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716 C202030012 Spain ⤷  Try a Trial 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 2020C/505 Belgium ⤷  Try a Trial PRODUCT NAME: UPADACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716 122020000011 Germany ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.