Lupkynis is a drug owned by Aurinia Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2021 to 2023 out of which none have expired yet. Lupkynis's patents will be open to challenges from 22 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2037. Details of Lupkynis'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. | |||
| US7332472 | Cyclosporine analogue mixtures and their use as immunomodulating agents |
Oct, 2025
(10 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10286036 | Protocol for treatment of lupus nephritis |
Dec, 2037
(13 years from now) | Active |
| US11622991 | Protocol for treatment of lupus nephritis |
Dec, 2037
(13 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 Lupkynis's patents.
Latest Legal Activities on Lupkynis's Patents
Given below is the list of recent legal activities going on the following patents of Lupkynis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US7332472 |
| transaction for FDA Determination of Regulatory Review Period | 29 Nov, 2023 | US7332472 |
| Interim Patent Term Extension Granted Critical | 02 Oct, 2023 | US7332472 |
| Post Issue Communication - Certificate of Correction | 27 May, 2023 | US11622991 |
| Recordation of Patent Grant Mailed Critical | 11 Apr, 2023 | US11622991 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Apr, 2023 | US11622991 |
| Email Notification Critical | 23 Mar, 2023 | US11622991 |
| Issue Notification Mailed Critical | 22 Mar, 2023 | US11622991 |
| Email Notification Critical | 13 Mar, 2023 | US11622991 |
| Mailing Corrected Notice of Allowability | 13 Mar, 2023 | US11622991 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lupkynis and ongoing litigations to help you estimate the early arrival of Lupkynis generic.
Lupkynis's Litigations
Lupkynis been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 24, 2022, against patent number US10286036. The petitioner Sun Pharmaceutical Industries Ltd. et al., challenged the validity of this patent, with Aurinia Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Lupkynis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10286036 | February, 2022 |
Terminated-Settled
(25 Jan, 2023) | Aurinia Pharmaceuticals Inc. | Sun Pharmaceutical Industries Ltd. et al. |
FDA has granted some exclusivities to Lupkynis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lupkynis, 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 Lupkynis.
Exclusivity Information
Lupkynis holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Lupkynis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 22, 2026 |
US patents provide insights into the exclusivity only within the United States, but Lupkynis 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 Lupkynis's family patents as well as insights into ongoing legal events on those patents.
Lupkynis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lupkynis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 07, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lupkynis Generics:
There are no approved generic versions for Lupkynis as of now.
About Lupkynis
Lupkynis is a drug owned by Aurinia Pharmaceuticals Inc. It is used for the treatment of active lupus nephritis. Lupkynis uses Voclosporin as an active ingredient. Lupkynis was launched by Aurinia in 2021.
Approval Date:
Lupkynis was approved by FDA for market use on 22 January, 2021.
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 Lupkynis is 22 January, 2021, its NCE-1 date is estimated to be 22 January, 2025.
Active Ingredient:
Lupkynis uses Voclosporin as the active ingredient. Check out other Drugs and Companies using Voclosporin ingredient
Treatment:
Lupkynis is used for the treatment of active lupus nephritis.
Dosage:
Lupkynis is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 7.9MG | CAPSULE | Prescription | ORAL |