Sotyktu is a drug owned by Bristol Myers Squibb Co. It is protected by 4 US drug patents filed from 2022 to 2026 out of which none have expired yet. Sotyktu's patents will be open to challenges from 09 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 11, 2043. Details of Sotyktu'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. | |||
| USRE47929 | Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFNα responses |
Nov, 2033
(7 years from now) | Active |
| US10000480 | Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses |
Nov, 2033
(7 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). | |||
| US12521390 | Dosage Forms For Tyk2 Inhibitors |
Feb, 2043
(16 years from now) | Active |
| US11021475 | Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses |
Nov, 2033
(7 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 Sotyktu's patents.
Latest Legal Activities on Sotyktu's Patents
Given below is the list of recent legal activities going on the following patents of Sotyktu.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Final Rejection (PTOL - 326) | 08 Sep, 2025 | US12521390 |
| Final Rejection | 26 Aug, 2025 | US12521390 |
| Information Disclosure Statement considered | 24 Jul, 2025 | US12521390 |
| Date Forwarded to Examiner | 06 Jul, 2025 | US12521390 |
| Response after Non-Final Action | 28 Jun, 2025 | US12521390 |
| Information Disclosure Statement (IDS) Filed | 28 Jun, 2025 | US12521390 |
| Request for Extension of Time - Granted | 28 Jun, 2025 | US12521390 |
| Mail Examiner Interview Summary (PTOL - 413) | 27 Jun, 2025 | US12521390 |
| Interview Summary - Applicant Initiated - Conference | 18 Jun, 2025 | US12521390 |
| Interview Summary Record | 18 Jun, 2025 | US12521390 |
FDA has granted several exclusivities to Sotyktu. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sotyktu, 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
Sotyktu.
Exclusivity Information
Sotyktu holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Sotyktu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 09, 2027 |
US patents provide insights into the exclusivity only within the United States, but
Sotyktu 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 Sotyktu's family patents as well as insights into
ongoing legal events
on those patents.
Sotyktu's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sotyktu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 11, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sotyktu Generics:
There are no approved generic versions for Sotyktu as of now.
About Sotyktu
Sotyktu is a drug owned by Bristol Myers Squibb Co. It is used for treating moderate-to-severe plaque psoriasis in adults who may benefit from systemic therapy or phototherapy. Sotyktu uses Deucravacitinib as an active ingredient. Sotyktu was launched by Bristol in 2022.
Approval Date:
Sotyktu was approved by FDA for market use on 09 September, 2022.
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 Sotyktu is 09 September, 2022, its NCE-1 date is estimated to be 09 September, 2026.
Active Ingredient:
Sotyktu uses Deucravacitinib as the active ingredient. Check out other Drugs and Companies using Deucravacitinib ingredient
Treatment:
Sotyktu is used for treating moderate-to-severe plaque psoriasis in adults who may benefit from systemic therapy or phototherapy.
Dosage:
Sotyktu is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG | TABLET | Prescription | ORAL |