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Last Updated: July 22, 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 two branded drugs marketed by Abbvie and is included in two NDAs. 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-six 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
Sixth Affiliated Hospital, Sun Yat-sen UniversityN/A
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A
Marie Hudson, MDN/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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Supplementary Protection Certificates for upadacitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506716 2020006 Norway ⤷  Sign Up PRODUCT NAME: UPADACITINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/19/1404 20200103
2506716 SPC/GB20/012 United Kingdom ⤷  Sign Up 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 132020000000022 Italy ⤷  Sign Up PRODUCT NAME: UPADACITINIB IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(RINVOQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1404, 20191218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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