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Last Updated: November 22, 2024

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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 thirty-seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-seven 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
University of OttawaPhase 4
The Ottawa HospitalPhase 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-one US patents and nine FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
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Patent Number: ⤷  Sign Up
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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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS


Patent Number: ⤷  Sign Up
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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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
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Patented Use: TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS


Patent Number: ⤷  Sign Up
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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


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Patent Number: ⤷  Sign Up
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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: ⤷  Sign Up
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Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS


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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


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


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Patented Use: TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS


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Patent Number: ⤷  Sign Up
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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


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


Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS


Patent Number: ⤷  Sign Up
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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


Patent Number: ⤷  Sign Up
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Tricyclic compounds
Patent Number: ⤷  Sign Up
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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: ⤷  Sign Up
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Patented Use: TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
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Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
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Patented Use: TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

Tricyclic compounds
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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: ⤷  Sign Up
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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: ⤷  Sign Up
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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: ⤷  Sign Up
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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
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Tricyclic compounds
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FDA Regulatory Exclusivity protecting RINVOQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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

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

TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TUMOR NECROSIS FACTOR (TNF) BLOCKERS, AND FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OF MORE TUMOR NECROSIS FACTOR (TNF) BLOCKERS
Exclusivity Expiration: ⤷  Sign Up

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 211675-002 Jan 14, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes ⤷  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 Y Y ⤷  Sign Up
Abbvie RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-001 Aug 16, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie RINVOQ LQ upadacitinib SOLUTION;ORAL 218347-001 Apr 26, 2024 RX Yes Yes ⤷  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 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
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: ⤷  Sign Up

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

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: ⤷  Sign Up

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: ⤷  Sign Up

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
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Patent: 2022005765
Patent: Tratamento contra afecções espondiloartríticas e psoriáticas com upadacitinib
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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: ⤷  Sign Up

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)
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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)
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Patent: 56170
Patent: TRAITEMENT DES SPONDYLOPATHIES ET DES AFFECTIONS PSORIASIQUES PAR UPADACITINIB (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB)
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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)
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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)
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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)
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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)
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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)
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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)
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Patent: 37686
Patent: TRAITEMENT DES SPONDYLOPATHIES ET DES AFFECTIONS PSORIASIQUES PAR UPADACITINIB (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB)
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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)
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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)
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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)
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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)
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Japan

Patent: 70775
Estimated Expiration: ⤷  Sign Up

Patent: 58317
Estimated Expiration: ⤷  Sign Up

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
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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)
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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
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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
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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)
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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.)
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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.)
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Patent: 22003872
Patent: TRATAMIENTO DE AFECCIONES ESPONDILOARTRÍTICAS Y PSORIÁSICAS CON UPADACITINIB. (TREATING SPONDYLOARTHRITIC AND PSORIATIC CONDITIONS WITH UPADACITINIB.)
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Russian Federation

Patent: 18117889
Estimated Expiration: ⤷  Sign Up

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
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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
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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
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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
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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
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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
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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
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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
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South Korea

Patent: 180081523
Estimated Expiration: ⤷  Sign Up

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
Luxembourg C00149 ⤷  Sign Up
European Patent Office 3592353 PROCÉDÉS DE TRAITEMENT DE LA MALADIE DE CROHN ET DE LA RECTOCOLITE HÉMORRAGIQUE (METHODS OF TREATING CROHN'S DISEASE AND ULCERATIVE COLITIS) ⤷  Sign Up
Canada 3002220 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) ⤷  Sign Up
Argentina 114947 COMPUESTOS TRICÍCLICOS ⤷  Sign Up
Brazil 112019018576 métodos de tratamento de doença de crohn e colite ulcerativa ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RINVOQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506716 2020/010 Ireland ⤷  Sign Up 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 CR 2020 00011 Denmark ⤷  Sign Up PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716 723 Finland ⤷  Sign Up
2506716 LUC00149 Luxembourg ⤷  Sign Up PRODUCT NAME: UPADACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1404 20191218
2506716 12/2020 Austria ⤷  Sign Up PRODUCT NAME: UPADACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1404 (MITTEILUNG) 20191218
>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.