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
Sponsor | Phase |
---|---|
Lady Davis Institute | N/A |
Montreal General Hospital | N/A |
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Phase 4 |
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 |