Rinvoq Patent Expiration

Rinvoq is a drug owned by Abbvie Inc. It is protected by 37 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.
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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 years from now)

Active
USRE47221 Tricyclic compounds
Aug, 2033

(8 years from now)

Active
US8962629 Tricyclic compounds
Jan, 2031

(6 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

(13 years from now)

Active
US11564922 Methods of treating crohn's disease and ulcerative colitis
Mar, 2038

(13 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

(12 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

(12 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

(12 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

(12 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

(12 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

(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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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

(12 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.

Given below is the list of recent legal activities going on the following patents of Rinvoq.

Activity Date Patent Number
Patent litigations
Withdrawal of Application for PTE 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 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 9 exclusivities out of which 1 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
Orphan Drug Exclusivity(ODE-481) Apr 26, 2031

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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
Patent litigations
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

Rinvoq has patent protection in a total of 41 countries. It's US patent count contributes only to 34.9% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Rinvoq.

Family Patents

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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
Rinvoq Lq






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
45MG TABLET, EXTENDED RELEASE Prescription ORAL
30MG TABLET, EXTENDED RELEASE Prescription ORAL
15MG TABLET, EXTENDED RELEASE Prescription ORAL


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20 Aug, 2024

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25 Jul, 2024

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