UPADACITINIB - Generic Drug Details
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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
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
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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | RINVOQ | upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675-003 | Mar 16, 2022 | RX | Yes | Yes | ⤷ 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 | 211675-002 | Jan 14, 2022 | 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 | Y | Y | ⤷ 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 | 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 | ||
>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 |
---|---|---|---|
European Patent Office | 3266786 | NOUVEAUX COMPOSÉS TRICYCLIQUES (NOVEL TRICYCLIC COMPOUNDS) | ⤷ Try a Trial |
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 | ⤷ Try a Trial |
Cyprus | 1117165 | ⤷ Try a Trial | |
South Korea | 20160148053 | 신규한 트리사이클릭 화합물 (Novel tricyclic compounds) | ⤷ Try a Trial |
Taiwan | 201434841 | 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 |
South Korea | 20110017431 | NOVEL TRICYCLIC COMPOUNDS | ⤷ 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 | 2090010-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/19/1404 20191218 |
2506716 | CA 2020 00011 | Denmark | ⤷ Try a Trial | PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218 |
2506716 | PA2020505,C2506716 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216 |
2506716 | 132020000000022 | Italy | ⤷ Try a Trial | 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 | ⤷ 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 | C02506716/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: UPADACITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67257 20.01.2020 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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