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Last Updated: May 31, 2023

RINVOQ Drug Patent Profile


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When do Rinvoq patents expire, and when can generic versions of Rinvoq launch?

Rinvoq is a drug marketed by Abbvie Inc and is included in one NDA. There are seventeen patents protecting this drug.

This drug has one hundred and sixty-three patent family members in forty-one countries.

The generic ingredient in RINVOQ is upadacitinib. One supplier is listed for this compound. Additional details are available on the upadacitinib profile page.

DrugPatentWatch® Generic Entry Outlook for Rinvoq

Rinvoq will be eligible for patent challenges on August 16, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RINVOQ
International Patents:163
US Patents:17
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 47
Clinical Trials: 33
Patent Applications: 369
Drug Prices: Drug price information for RINVOQ
What excipients (inactive ingredients) are in RINVOQ?RINVOQ excipients list
DailyMed Link:RINVOQ at DailyMed
Drug patent expirations by year for RINVOQ
Drug Prices for RINVOQ

See drug prices for RINVOQ

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

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

SponsorPhase
The Ottawa HospitalPhase 4
Ottawa Hospital Research InstitutePhase 4
University of OttawaPhase 4

See all RINVOQ clinical trials

US Patents and Regulatory Information for RINVOQ

RINVOQ is protected by twenty-two US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RINVOQ is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RINVOQ

Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-.alpha.]pyrrolo[2,3-e]-pyrazin-8-yl)-N-- (2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE TO SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE

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-carb oxamide and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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-carb oxamide and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE TO SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH OBJECTIVE SIGNS OF INFLAMMATION WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tricyclic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting RINVOQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE-TO-SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, INCLUDING BIOLOGICS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: ⤷  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
Abbvie Inc 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 Inc 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 Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes ⤷  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 RINVOQ

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 RINVOQ

When does loss-of-exclusivity occur for RINVOQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 16340167
Estimated Expiration: ⤷  Try a Trial

Patent: 20359635
Estimated Expiration: ⤷  Try a Trial

Patent: 21236570
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2018007677
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 02220
Estimated Expiration: ⤷  Try a Trial

Patent: 23260
Estimated Expiration: ⤷  Try a Trial

Patent: 56170
Estimated Expiration: ⤷  Try a Trial

China

Patent: 8368121
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 62455
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 63380
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8654
Estimated Expiration: ⤷  Try a Trial

Patent: 3531
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 70775
Estimated Expiration: ⤷  Try a Trial

Patent: 19501865
Estimated Expiration: ⤷  Try a Trial

Patent: 21020902
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18004605
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 18117889
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201913986Y
Estimated Expiration: ⤷  Try a Trial

Patent: 201913987U
Estimated Expiration: ⤷  Try a Trial

Patent: 201913989Q
Estimated Expiration: ⤷  Try a Trial

Patent: 201913990R
Estimated Expiration: ⤷  Try a Trial

Patent: 201913993Q
Estimated Expiration: ⤷  Try a Trial

Patent: 201913997W
Estimated Expiration: ⤷  Try a Trial

Patent: 201913999P
Estimated Expiration: ⤷  Try a Trial

Patent: 201802990R
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 180081523
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RINVOQ around the world.

Country Patent Number Title Estimated Expiration
Netherlands 301035 ⤷  Try a Trial
China 102711476 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RINVOQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506716 122020000011 Germany ⤷  Try a Trial PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716 C02506716/01 Switzerland ⤷  Try a Trial PRODUCT NAME: UPADACITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67257 20.01.2020
2506716 723 Finland ⤷  Try a Trial
>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.