Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Baxter
Moodys
Colorcon
McKesson

Last Updated: May 26, 2022

RINVOQ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 fourteen patents protecting this drug.

This drug has one hundred and fifty-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

< Available with Subscription >

  Sign up for a Free Trial

Summary for RINVOQ
International Patents:153
US Patents:14
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 29
Patent Applications: 36
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 Generic Entry Opportunity 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 sixteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RINVOQ is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tricyclic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tricyclic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting RINVOQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Exclusivity Expiration: See Plans and Pricing

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: 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
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-003 Mar 16, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 Y See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc RINVOQ upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675-002 Jan 14, 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 211675-001 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 211675-001 Aug 16, 2019 RX Yes No 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

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: See Plans and Pricing

Patent: 21236570
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2018007677
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02220
Estimated Expiration: See Plans and Pricing

Patent: 23260
Estimated Expiration: See Plans and Pricing

China

Patent: 8368121
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 62455
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 63380
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8654
Estimated Expiration: See Plans and Pricing

Patent: 3531
Estimated Expiration: See Plans and Pricing

Japan

Patent: 70775
Estimated Expiration: See Plans and Pricing

Patent: 19501865
Estimated Expiration: See Plans and Pricing

Patent: 21020902
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18004605
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18117889
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201913986Y
Estimated Expiration: See Plans and Pricing

Patent: 201913987U
Estimated Expiration: See Plans and Pricing

Patent: 201913989Q
Estimated Expiration: See Plans and Pricing

Patent: 201913990R
Estimated Expiration: See Plans and Pricing

Patent: 201913993Q
Estimated Expiration: See Plans and Pricing

Patent: 201913997W
Estimated Expiration: See Plans and Pricing

Patent: 201913999P
Estimated Expiration: See Plans and Pricing

Patent: 201802990R
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180081523
Estimated Expiration: See Plans and Pricing

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
Hungary E028347 See Plans and Pricing
China 104370909 Novel tricyclic compounds See Plans and Pricing
Singapore 10201913999P 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
Dominican Republic P2010000382 NUEVOS COMPUESTOS TRICICLICOS See Plans and Pricing
Croatia P20171175 See Plans and Pricing
Mexico 2018004605 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.) See Plans and Pricing
Singapore 10201913997W 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RINVOQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 2020/010 Ireland See Plans and Pricing 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 PA2020505 Lithuania See Plans and Pricing PRODUCT NAME: UPADACITINIBAS; REGISTRATION NO/DATE: EU/1/19/1404 20191216
2506716 20C1009 France See Plans and Pricing PRODUCT NAME: UPADACITINIB OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1404 20191218
2506716 C02506716/01 Switzerland See Plans and Pricing PRODUCT NAME: UPADACITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67257 20.01.2020
2506716 CA 2020 00011 Denmark See Plans and Pricing PRODUCT NAME: UPADACITINIB; REG. NO/DATE: EU/1/19/1404 20191218
2506716 C20200006 00317 Estonia See Plans and Pricing PRODUCT NAME: UPADATSITINIIB;REG NO/DATE: EU/1/19/1404; 18.12.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
McKesson
Dow
McKinsey
Colorcon

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.