Rinvoq is a drug owned by Abbvie Inc. It is protected by 43 US drug patents filed from 2019 to 2024 out of which none have expired yet. Rinvoq's patents have been open to challenges since 17 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 09, 2038. Details of Rinvoq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US12110298 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11661425 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10981923 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11718627 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11186584 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11773105 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11680069 | 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 |
Oct, 2036
(11 years from now) | Active |
| US9951080 | 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 |
Oct, 2036
(11 years from now) | Active |
| USRE47221 | Tricyclic compounds |
Aug, 2033
(8 years from now) | Active |
| US8962629 | Tricyclic compounds |
Jan, 2031
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11607411 | Methods of treating Crohn's disease and ulcerative colitis |
Mar, 2038
(12 years from now) | Active |
| US11564922 | Methods of treating crohn's disease and ulcerative colitis |
Mar, 2038
(12 years from now) | Active |
| US10550126 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10995095 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10597400 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11780848 | 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 |
Oct, 2036
(11 years from now) | Active |
| US12091415 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10981924 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11198697 | 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 |
Oct, 2036
(11 years from now) | Active |
| US12103933 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10344036 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10202393 | Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof |
Oct, 2036
(11 years from now) | Active |
| US10519164 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11535624 | Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof |
Oct, 2036
(11 years from now) | Active |
| US11535625 | Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof |
Oct, 2036
(11 years from now) | Active |
| US11535626 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11767326 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11524964 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11976077 | Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms therof |
Oct, 2036
(11 years from now) | Active |
| US12134621 | 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 |
Oct, 2036
(11 years from now) | Active |
| US12077545 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11787815 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11780847 | 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 |
Oct, 2036
(11 years from now) | Active |
| US9963459 | 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 |
Oct, 2036
(11 years from now) | Active |
| US12116373 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11512092 | 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 |
Oct, 2036
(11 years from now) | Active |
| US10730883 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11795175 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11365198 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11773106 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11993605 | 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 |
Oct, 2036
(11 years from now) | Active |
| US11993606 | 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 |
Oct, 2036
(11 years from now) | Active |
| US12110297 | 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 |
Oct, 2036
(11 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rinvoq's patents.
Latest Legal Activities on Rinvoq's Patents
Given below is the list of recent legal activities going on the following patents of Rinvoq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Withdrawal of Application for PTE Critical | 14 May, 2024 | US8962629 |
| Mail Certificate of Correction Memo | 03 Apr, 2024 | US11512092 |
| Certificate of Correction Memo | 01 Apr, 2024 | US11512092 |
| Mail Certificate of Correction Memo | 28 Mar, 2024 | US10550126 |
| Mail Certificate of Correction Memo | 28 Mar, 2024 | US11365198 |
| Certificate of Correction Memo | 27 Mar, 2024 | US10550126 |
| Certificate of Correction Memo | 27 Mar, 2024 | US11365198 |
| Notice of Final Determination -Election Required | 21 Mar, 2024 | US8962629 |
| Patent eCofC Notification | 05 Mar, 2024 | US11767326 |
| Email Notification Critical | 05 Mar, 2024 | US11767326 |
FDA has granted several exclusivities to Rinvoq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rinvoq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rinvoq.
Exclusivity Information
Rinvoq holds 10 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Rinvoq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 16, 2024 |
| New Indication(I-880) | Dec 14, 2024 |
| New Indication(I-883) | Jan 14, 2025 |
| New Indication(I-886) | Mar 16, 2025 |
| New Indication(I-888) | Apr 29, 2025 |
| New Indication(I-919) | May 18, 2026 |
| New Indication(I-946) | Apr 26, 2027 |
| New Patient Population(NPP) | Apr 26, 2027 |
| New Indication(I-966) | Apr 28, 2028 |
| Orphan Drug Exclusivity(ODE-481) | Apr 26, 2031 |
Several oppositions have been filed on Rinvoq's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rinvoq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rinvoq patents.
Rinvoq's Oppositions Filed in EPO
Rinvoq has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 16, 2018, by Generics (U.K.) Limited. This opposition was filed on patent number EP10835061A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10835061A | Feb, 2018 | Generics (U.K.) Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Rinvoq is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rinvoq's family patents as well as insights into ongoing legal events on those patents.
Rinvoq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rinvoq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 09, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rinvoq Generics:
There are no approved generic versions for Rinvoq as of now.
Alternative Brands for Rinvoq
Rinvoq which is used for treating a variety of inflammatory conditions including atopic dermatitis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, rheumatoid arthritis, and ulcerative colitis., has several other brand drugs using the same active ingredient (Upadacitinib). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
About Rinvoq
Rinvoq is a drug owned by Abbvie Inc. It is used for treating a variety of inflammatory conditions including atopic dermatitis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, rheumatoid arthritis, and ulcerative colitis. Rinvoq uses Upadacitinib as an active ingredient. Rinvoq was launched by Abbvie in 2019.
Approval Date:
Rinvoq was approved by FDA for market use on 16 August, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rinvoq is 16 August, 2019, its NCE-1 date is estimated to be 17 August, 2023.
Active Ingredient:
Rinvoq uses Upadacitinib as the active ingredient. Check out other Drugs and Companies using Upadacitinib ingredient
Treatment:
Rinvoq is used for treating a variety of inflammatory conditions including atopic dermatitis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, rheumatoid arthritis, and ulcerative colitis.
Dosage:
Rinvoq is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 45MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |