Klisyri is a drug owned by Almirall Llc. It is protected by 8 US drug patents filed from 2021 to 2022 out of which none have expired yet. Klisyri's patents have been open to challenges since 14 December, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2038. Details of Klisyri'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. | |||
| US10669236 | Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide |
Sep, 2038
(13 years from now) | Active |
| US7851470 | Composition and methods for modulating a kinase cascade |
Feb, 2029
(3 years from now) | Active |
| US7300931 | Compositions for treating cell proliferation disorders |
Feb, 2026
(6 months from now) | Active |
| US8980890 | Compositions and methods of treating cell proliferation disorders |
Dec, 2025
(5 months from now) | Active |
| US8236799 | Biaryl compositions and methods for modulating a kinase cascade |
Dec, 2025
(5 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). | |||
| US10617693 | Methods of treating and/or preventing actinic keratosis |
Mar, 2038
(12 years from now) | Active |
| US11497750 | Methods of treating and/or preventing actinic keratosis |
Mar, 2038
(12 years from now) | Active |
| US10323001 | Compositions for modulating a kinase cascade and methods of use thereof |
Dec, 2027
(2 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 Klisyri's patents.
Latest Legal Activities on Klisyri's Patents
Given below is the list of recent legal activities going on the following patents of Klisyri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US7851470 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US7300931 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US7300931 |
| transaction for FDA Determination of Regulatory Review Period | 23 Feb, 2024 | US7851470 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Feb, 2024 | US8236799 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Nov, 2023 | US10669236 |
| Email Notification Critical | 18 Oct, 2023 | US8980890 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Oct, 2023 | US8980890 |
| Email Notification Critical | 17 Oct, 2023 | US10323001 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Oct, 2023 | US10617693 |
FDA has granted several exclusivities to Klisyri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Klisyri, 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 Klisyri.
Exclusivity Information
Klisyri holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Klisyri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2025 |
| New Dosing Schedule(D-192) | Jun 07, 2027 |
US patents provide insights into the exclusivity only within the United States, but Klisyri 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 Klisyri's family patents as well as insights into ongoing legal events on those patents.
Klisyri's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Klisyri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Klisyri Generics:
There are no approved generic versions for Klisyri as of now.
About Klisyri
Klisyri is a drug owned by Almirall Llc. It is used for treating actinic keratosis on the face or scalp. Klisyri uses Tirbanibulin as an active ingredient. Klisyri was launched by Almirall in 2020.
Approval Date:
Klisyri was approved by FDA for market use on 14 December, 2020.
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 Klisyri is 14 December, 2020, its NCE-1 date is estimated to be 14 December, 2024.
Active Ingredient:
Klisyri uses Tirbanibulin as the active ingredient. Check out other Drugs and Companies using Tirbanibulin ingredient
Treatment:
Klisyri is used for treating actinic keratosis on the face or scalp.
Dosage:
Klisyri is available in ointment form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | OINTMENT | Prescription | TOPICAL |