Zoryve is a drug owned by Arcutis Biotherapeutics Inc. It is protected by 14 US drug patents filed from 2023 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 03, 2041. Details of Zoryve's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11707454 | Topical roflumilast formulation having antifungal properties |
Dec, 2041
(16 years from now) | Active |
| US11129818 | Topical roflumilast formulation having improved delivery and plasma half life |
Aug, 2037
(12 years from now) | Active |
| US9907788 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(12 years from now) | Active |
| US11819496 | Topical roflumilast formulation having improved delivery and plasma half-life |
Jun, 2037
(12 years from now) | Active |
| US12005051 | Topical roflumilast formulation having improved delivery and plasma half life |
Jun, 2037
(12 years from now) | Active |
| US10940142 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(12 years from now) | Active |
| US12220409 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(12 years from now) | Active |
| US12011437 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(12 years from now) | Active |
| US12042487 | Method for reducing side effects from administration of phosphodiesterase-4 inhibitors |
Jun, 2037
(12 years from now) | Active |
| US12016848 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(12 years from now) | Active |
| US9884050 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(12 years from now) | Active |
| US12005052 | Topical roflumilast formulation having improved delivery and plasma half-life |
Jun, 2037
(12 years from now) | Active |
| US11793796 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(12 years from now) | Active |
| US11992480 | Method for reducing side effects from administration of phosphodiesterase-4 inhibitors |
Jun, 2037
(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 Zoryve's patents.
Latest Legal Activities on Zoryve's Patents
Given below is the list of recent legal activities going on the following patents of Zoryve.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US9884050 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 May, 2024 | US10940142 |
| Mail O.P. Petition Decision | 11 Mar, 2024 | US9884050 |
| Email Notification Critical | 11 Mar, 2024 | US9884050 |
| Mail-Petition Decision - Dismissed Critical | 07 Mar, 2024 | US9884050 |
| Petition Decision - Dismissed Critical | 06 Mar, 2024 | US9884050 |
| O.P. Petition Decision | 05 Mar, 2024 | US9884050 |
| Mail O.P. Petition Decision | 12 Feb, 2024 | US11819496 |
| Email Notification Critical | 12 Feb, 2024 | US11819496 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 08 Feb, 2024 | US11819496 |
FDA has granted several exclusivities to Zoryve. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zoryve, 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 Zoryve.
Exclusivity Information
Zoryve holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zoryve's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 15, 2026 |
| New Patient Population(NPP) | Oct 05, 2026 |
| New Strength(NS) | Jul 09, 2027 |
US patents provide insights into the exclusivity only within the United States, but Zoryve 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 Zoryve's family patents as well as insights into ongoing legal events on those patents.
Zoryve's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zoryve's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 03, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zoryve Generic API suppliers:
Roflumilast is the generic name for the brand Zoryve. 11 different companies have already filed for the generic of Zoryve, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zoryve's generic
Alternative Brands for Zoryve
Zoryve which is used for the topical treatment of plaque psoriasis, including intertriginous areas, and seborrheic dermatitis in patients of various ages., has several other brand drugs using the same active ingredient (Roflumilast). 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 | |
|---|---|---|
| Astrazeneca |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Roflumilast, Zoryve's active ingredient. Check the complete list of approved generic manufacturers for Zoryve
About Zoryve
Zoryve is a drug owned by Arcutis Biotherapeutics Inc. It is used for the topical treatment of plaque psoriasis, including intertriginous areas, and seborrheic dermatitis in patients of various ages. Zoryve uses Roflumilast as an active ingredient. Zoryve was launched by Arcutis in 2023.
Approval Date:
Zoryve was approved by FDA for market use on 15 December, 2023.
Active Ingredient:
Zoryve uses Roflumilast as the active ingredient. Check out other Drugs and Companies using Roflumilast ingredient
Treatment:
Zoryve is used for the topical treatment of plaque psoriasis, including intertriginous areas, and seborrheic dermatitis in patients of various ages.
Dosage:
Zoryve is available in the following dosage forms - foam form for topical use, cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3% | FOAM | Prescription | TOPICAL |
| 0.15% | CREAM | Prescription | TOPICAL |