Zoryve is a drug owned by Arcutis Biotherapeutics Inc. It is protected by 19 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 |
| US12329751 | NA |
Dec, 2041
(16 years from now) | Active |
| US11129818 | Topical roflumilast formulation having improved delivery and plasma half life |
Aug, 2037
(11 years from now) | Active |
| US11819496 | Topical roflumilast formulation having improved delivery and plasma half-life |
Jun, 2037
(11 years from now) | Active |
| US12005051 | Topical roflumilast formulation having improved delivery and plasma half life |
Jun, 2037
(11 years from now) | Active |
| US9907788 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(11 years from now) | Active |
| US11992480 | Method for reducing side effects from administration of phosphodiesterase-4 inhibitors |
Jun, 2037
(11 years from now) | Active |
| US10940142 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(11 years from now) | Active |
| US12011437 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(11 years from now) | Active |
| US12042487 | Method for reducing side effects from administration of phosphodiesterase-4 inhibitors |
Jun, 2037
(11 years from now) | Active |
| US12016848 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(11 years from now) | Active |
| US12220409 | Roflumilast formulations with an improved pharmacokinetic profile |
Jun, 2037
(11 years from now) | Active |
| US12336983 | NA |
Jun, 2037
(11 years from now) | Active |
| US9884050 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(11 years from now) | Active |
| US12005052 | Topical roflumilast formulation having improved delivery and plasma half-life |
Jun, 2037
(11 years from now) | Active |
| US12257242 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(11 years from now) | Active |
| US11793796 | Inhibition of crystal growth of roflumilast |
Jun, 2037
(11 years from now) | Active |
| US12390453 | NA |
Jun, 2037
(11 years from now) | Active |
| US12310956 | Topical roflumilast formulation having improved delivery and plasma half-life |
Jun, 2037
(11 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 4 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. 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 |
| New Indication(I-969) | May 22, 2028 |
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 Zydus Pharms 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 cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3% | CREAM | Prescription | TOPICAL |
| 0.15% | CREAM | Prescription | TOPICAL |