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Last Updated: January 5, 2025

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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 and is included in two NDAs. There are forty patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-eight 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 was eligible for patent challenges on August 16, 2023.

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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for RINVOQ
Drug Prices for RINVOQ

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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
Berinstein, JeffreyPhase 4
The Ottawa HospitalPhase 4
Ottawa Hospital Research InstitutePhase 4

See all RINVOQ clinical trials

Pharmacology for RINVOQ
Drug ClassJanus Kinase Inhibitor
Mechanism of ActionJanus Kinase Inhibitors
Paragraph IV (Patent) Challenges for RINVOQ
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 RINVOQ

RINVOQ is protected by fifty-three US patents and nine FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent 9,951,080.

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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No 9,963,459 ⤷  Subscribe Y ⤷  Subscribe
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No 11,198,697 ⤷  Subscribe Y ⤷  Subscribe
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 2022 RX Yes No 11,661,425 ⤷  Subscribe Y Y ⤷  Subscribe
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes 11,607,411 ⤷  Subscribe ⤷  Subscribe
Abbvie RINVOQ LQ upadacitinib SOLUTION;ORAL 218347-001 Apr 26, 2024 RX Yes Yes 11,661,425 ⤷  Subscribe Y ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

EU/EMA Drug Approvals for RINVOQ

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
Showing 1 to 1 of 1 entries

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
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 20359635
Patent: Treating spondyloarthritic and psoriatic conditions with upadacitinib
Estimated Expiration: ⤷  Subscribe

Patent: 21236570
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 23251492
Patent: 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
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2018007677
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 2022005765
Patent: Tratamento contra afecções espondiloartríticas e psoriáticas com upadacitinib
Estimated Expiration: ⤷  Subscribe

Patent: 2022024925
Patent: Composição farmacêutica de liberação prolongada compreendendo (3s,4r)-3-etil-4-(3h-imidazo[1,2-a]pirrolo[2,3-e]pirazin-8-il)-n-(2,2,2-trifluoroetil)pirroli-dina-1-carboxamida
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 02220
Patent: PROCEDE DE PREPARATION DE (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 ET DE SES FORMES A L'ETAT 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)
Estimated Expiration: ⤷  Subscribe

Patent: 23260
Patent: HEMIHYDRATE CRISTALLIN DE (3S,4R)-3-ETHYL-4-(3H-IMIDAZO[1,2-A]PYRROLO[2,3-E]PYRAZINE-8-YL)-N-(2,2,2-TRIFLUOROETHYL)PYRROLIDINE-1-CARBOXAMIDE ET FORME A L'ETAT SOLIDE (CRYSTALLINE HEMIHYDRATE 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 FORM THEREOF)
Estimated Expiration: ⤷  Subscribe

Patent: 56170
Patent: TRAITEMENT DES SPONDYLOPATHIES ET DES AFFECTIONS PSORIASIQUES PAR UPADACITINIB (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB)
Estimated Expiration: ⤷  Subscribe

China

Patent: 8368121
Patent: 制备(3S,4R)-3-乙基-4-(3H-咪唑并[1,2-a]吡咯并[2,3-e]吡嗪-8-基)-N-(2,2,2-三氟乙基)吡咯烷-1-甲酰胺及其固态形式的方法 (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)
Estimated Expiration: ⤷  Subscribe

Patent: 4929227
Patent: 用乌帕替尼治疗脊柱关节炎和银屑病 (Treatment of spinal arthritis and psoriasis with upatinib)
Estimated Expiration: ⤷  Subscribe

Patent: 6270645
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 6270646
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 6284011
Patent: 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)
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 62455
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 37686
Patent: TRAITEMENT DES SPONDYLOPATHIES ET DES AFFECTIONS PSORIASIQUES PAR UPADACITINIB (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB)
Estimated Expiration: ⤷  Subscribe

Patent: 19503
Patent: L-MALEATE SOUS FORME CRYSTALLINE 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 (CRYTALLINE L-MALEATE 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)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 63380
Patent: 製備(3S,4R)-3-乙基-4-(3H-咪唑並[1,2-A]吡咯並[2,3-E]吡嗪-8-基)-N-(2,2,2-三氟乙基)吡咯烷-1-甲醯胺及其固態形式的方法 (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)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 8654
Patent: תהליכים להכנת (3s,4r)-3-אתיל-4-(3h- אימידיאזו[1,2-a]פירולו[2, 3-e]-פיראזין-8-יל)-n-(2,2,2-טריפלורואתיל)פירולידין-1-קרבוקאמיד וצורות במצב מוצק שלהם (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)
Estimated Expiration: ⤷  Subscribe

Patent: 3531
Patent: תהליכים להכנת (3s,4r)-3-אתיל-4-(3h- אימידיאזו[1,2-a]פירולו[2, 3-e]-פיראזין-8-יל)-n-(2,2,2-טריפלורואתיל)פירולידין-1-קרבוקאמיד וצורות במצב מוצק שלהם (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)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 70775
Estimated Expiration: ⤷  Subscribe

Patent: 58317
Estimated Expiration: ⤷  Subscribe

Patent: 19501865
Patent: (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
Estimated Expiration: ⤷  Subscribe

Patent: 21020902
Patent: (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 (PROCESSES FOR 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)
Estimated Expiration: ⤷  Subscribe

Patent: 22107001
Patent: (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
Estimated Expiration: ⤷  Subscribe

Patent: 22549379
Patent: ウパダシチニブによる脊椎関節炎及び乾癬状態の治療
Estimated Expiration: ⤷  Subscribe

Patent: 23113917
Patent: (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 (METHODS FOR 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)
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 18004605
Patent: PROCESOS PARA LA PREPARACION DE (3S,4R)-3-ETIL-4-(3H-IMIDAZO-[1,2- A]-PIRROLO-[2,3-E]-PIRAZIN-8-IL)-N-(2,2,2-TRIFLUOROETIL)-PIRROLID IN-1-CARBOXAMIDA Y FORMAS EN ESTADO SOLIDO DE LA MISMA. (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)PYRROLI DINE-1-CARBOXAMIDE AND SOLID STATE FORMS THEREOF.)
Estimated Expiration: ⤷  Subscribe

Patent: 21013812
Patent: PROCESOS PARA LA PREPARACION DE (3S,4R)-3-ETIL-4-(3H-IMIDAZO[1,2-A ]PIRROLO[2,3-E]-PIRAZIN-8-IL)-N-(2,2,2-TRIFLUOROETIL) PIRROLIDIN-1-CARBOXAMIDA Y FORMAS EN ESTADO SOLIDO DE LA MISMA. (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)PYRROLI DINE-1-CARBOXAMIDE AND SOLID STATE FORMS THEREOF.)
Estimated Expiration: ⤷  Subscribe

Patent: 22003872
Patent: TRATAMIENTO DE AFECCIONES ESPONDILOARTRÍTICAS Y PSORIÁSICAS CON UPADACITINIB. (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB.)
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 18117889
Patent: СПОСОБЫ ПОЛУЧЕНИЯ (3S,4R)-3-ЭТИЛ-4-(3H-ИМИДАЗО[1,2-a]ПИРРОЛО[2,3-e]-ПИРАЗИН-8-ИЛ)-N-(2,2,2-ТРИФТОРЭТИЛ)ПИРРОЛИДИН-1-КАРБОКСАМИДА И ЕГО ТВЕРДОФАЗНЫХ ФОРМ
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201913986Y
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913987U
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913989Q
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913990R
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913993Q
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913997W
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201913999P
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 201802990R
Patent: 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
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 180081523
Estimated Expiration: ⤷  Subscribe

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.

CountryPatent NumberTitleEstimated Expiration
Cyprus 1117165 ⤷  Subscribe
Denmark 2299821 ⤷  Subscribe
Japan 2024073591 (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 (PROCESSES FOR 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) ⤷  Subscribe
Mexico 2012006311 NUEVOS COMPUESTOS TRICICLICOS. (NOVEL TRICYCLIC COMPOUNDS.) ⤷  Subscribe
Peru 20121336 NUEVOS COMPUESTOS TRICICLICOS ⤷  Subscribe
Russian Federation 2010153582 НОВЫЕ ТРИЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ ⤷  Subscribe
Taiwan 201612182 Novel tricyclic compounds ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for RINVOQ

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2506716 12/2020 Austria ⤷  Subscribe PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 (MITTEILUNG) 20191218
2506716 2020/010 Ireland ⤷  Subscribe PRODUCT NAME: UPADACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/19/1404 20191218; FIRST REGISTRATION NO/DATE: EU/1/19/1404 18/12/2019 (11/11/2020)
2506716 723 Finland ⤷  Subscribe
2506716 CA 2020 00011 Denmark ⤷  Subscribe PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
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RINVOQ Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: RINVOQ

Introduction to RINVOQ

RINVOQ, also known as upadacitinib, is a Janus kinase (JAK) inhibitor developed by AbbVie. It has been approved for several immunology indications, including moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

Approval and Indications

RINVOQ first received FDA approval in mid-2019 for the treatment of moderate to severe rheumatoid arthritis. Since then, it has been approved for multiple other immunology indications, expanding its market reach significantly[1][3].

Market Performance

Revenue Growth

RINVOQ has demonstrated robust revenue growth across its approved indications. In the third quarter of 2024, global net revenues for RINVOQ were $1.614 billion, representing a 45.3% increase on a reported basis and a 47.4% increase on an operational basis compared to the previous year[2][3].

Year-over-Year Growth

The drug's sales have been growing rapidly, with a year-over-year (YOY) growth rate of 43% in the rheumatoid arthritis market, making it the second largest driver of absolute growth in this segment, behind adalimumab (Humira)[1].

Market Share and Penetration

RINVOQ is capturing significant market share across its indications. For example, in the U.S., RINVOQ is now capturing double-digit in-play patient share for ulcerative colitis and Crohn’s disease. It is available in over 75 countries with increasing reimbursement and market share[3].

Key Indications and Market Impact

Rheumatoid Arthritis

In the rheumatoid arthritis market, RINVOQ is a major player, with its sales growing rapidly. It has been approved as a treatment for moderate to severe rheumatoid arthritis and has shown superiority over other treatments like Humira and Orencia in head-to-head studies[1][3].

Atopic Dermatitis

RINVOQ has also made significant strides in the atopic dermatitis market. Despite the dominance of Dupixent (dupilumab), RINVOQ has gained a license expansion for atopic dermatitis and is seeing an acceleration of in-play share following positive data from its second head-to-head study versus Dupixent[1][4].

Psoriasis and Other Indications

While psoriasis is a highly competitive market, RINVOQ is not as dominant here as it is in other indications. However, its sister drug, Skyrizi (risankizumab), is a major player in psoriasis, and together they contribute significantly to AbbVie's immunology portfolio[1][3].

Financial Projections and Outlook

Revenue Projections

AbbVie has raised its full-year sales guidance for RINVOQ multiple times due to its strong performance. The company now expects RINVOQ and Skyrizi combined to generate over $17 billion in sales, surpassing initial forecasts[3].

Long-Term Growth Prospects

The long-term growth prospects for RINVOQ are promising. AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s, driven by new indications and continued market penetration[3].

Market Forecast

According to market forecasts, RINVOQ's market size for atopic dermatitis alone is expected to grow substantially from 2022 to 2032, driven by extensive research and incremental healthcare spending globally[4].

Competitive Landscape

Differentiation and Head-to-Head Studies

RINVOQ's success is largely attributed to its strong differentiation and compelling head-to-head data against several novel therapies. It has shown superiority over Humira, Orencia, and Dupixent in various indications, which has been a key factor in its market success[3].

Emerging Competitors

The market for atopic dermatitis and other indications is expected to become more competitive with the launch of late-stage emerging therapies. However, RINVOQ's established position and ongoing research and development activities are expected to help it maintain its market dominance[4].

Regulatory and Developmental Activities

Regulatory Milestones

RINVOQ has achieved several regulatory milestones, including approvals for multiple indications. Ongoing studies and regulatory activities are expected to further expand its therapeutic portfolio[4].

Research and Development

AbbVie continues to invest in research and development for RINVOQ, including new head-to-head studies and expansion into new indications. This ongoing innovation is crucial for maintaining its competitive edge[3].

Financial Impact on AbbVie

Revenue Contribution

RINVOQ is a significant contributor to AbbVie's immunology portfolio, which saw global net revenues of $7.046 billion in the third quarter of 2024, an increase of 3.9% on a reported basis and 4.8% on an operational basis[2].

Earnings and Guidance

The strong performance of RINVOQ has led AbbVie to increase its full-year revenue and earnings guidance. Despite challenges from biosimilar competition to Humira, the growth of RINVOQ and other immunology products has been favorable for AbbVie's overall financial performance[2][3].

Conclusion

RINVOQ has established itself as a key player in the immunology market, driven by its rapid growth, strong differentiation, and expanding indications. With a robust financial trajectory and promising long-term growth prospects, RINVOQ is set to continue its dominance in the market.

Key Takeaways

  • Rapid Revenue Growth: RINVOQ has shown significant revenue growth, with a 45.3% increase in the third quarter of 2024.
  • Market Penetration: It has captured double-digit market share in several indications, including ulcerative colitis and Crohn’s disease.
  • Competitive Edge: Strong head-to-head data against other therapies has been a key factor in its success.
  • Long-Term Prospects: AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s.
  • Regulatory and Developmental Activities: Ongoing studies and regulatory activities are expected to further expand its therapeutic portfolio.

FAQs

Q: What are the approved indications for RINVOQ?

RINVOQ is approved for moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

Q: How has RINVOQ performed in terms of revenue growth?

RINVOQ's global net revenues were $1.614 billion in the third quarter of 2024, representing a 45.3% increase on a reported basis and a 47.4% increase on an operational basis.

Q: What is the competitive landscape for RINVOQ in atopic dermatitis?

RINVOQ competes with Dupixent (dupilumab) in the atopic dermatitis market but has shown promising results in head-to-head studies, leading to an acceleration of its market share.

Q: What are the long-term growth prospects for RINVOQ?

AbbVie anticipates significant revenue inflection in the second half of this decade and into the 2030s, driven by new indications and continued market penetration.

Q: How does RINVOQ contribute to AbbVie's financial performance?

RINVOQ is a significant contributor to AbbVie's immunology portfolio, which saw global net revenues of $7.046 billion in the third quarter of 2024, helping to offset declines in Humira sales due to biosimilar competition.

Sources

  1. IQVIA: "Delving deeper into the immunology and respiratory markets - IQVIA"[1]
  2. PR Newswire: "AbbVie Reports Third-Quarter 2024 Financial Results"[2]
  3. Investing.com: "Earnings call: AbbVie raises outlook on strong Q3 performance"[3]
  4. Research and Markets: "RINVOQ Market Drug Insight and Market Forecast - 2032"[4]
  5. AbbVie Investors: "AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results"[5]

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