Anzupgo is a drug owned by Leo Pharma As. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Anzupgo's patents will be open to challenges from 23 July, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 19, 2031. Details of Anzupgo'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. | |||
| US8609647 | Nitrogen-Containing Spirocyclic Compounds And Pharmaceutical Uses Thereof |
Sep, 2031
(5 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 Anzupgo's patents.
Latest Legal Activities on Anzupgo's Patents
Given below is the list of recent legal activities going on the following patents of Anzupgo.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Email Notification | 25 Sep, 2025 | US8609647 |
| Change in Power of Attorney (May Include Associate POA) | 25 Sep, 2025 | US8609647 |
| Initial letter Re: PTE Application to regulating agency | 08 Sep, 2025 | US8609647 |
| Patent Term Extension Application under 35 USC 156 Filed | 05 Sep, 2025 | US8609647 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 04 Jun, 2025 | US8609647 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Jun, 2021 | US8609647 |
| Post Issue Communication - Certificate of Correction | 04 Apr, 2014 | US8609647 |
| Patent Issue Date Used in PTA Calculation | 17 Dec, 2013 | US8609647 |
| Recordation of Patent Grant Mailed | 17 Dec, 2013 | US8609647 |
| Email Notification | 27 Nov, 2013 | US8609647 |
FDA has granted several exclusivities to Anzupgo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Anzupgo, 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
Anzupgo.
Exclusivity Information
Anzupgo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Anzupgo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Anzupgo 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 Anzupgo's family patents as well as insights into
ongoing legal events
on those patents.
Anzupgo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Anzupgo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 19, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Anzupgo Generics:
There are no approved generic versions for Anzupgo as of now.
About Anzupgo
Anzupgo is a drug owned by Leo Pharma As. Anzupgo uses Delgocitinib as an active ingredient. Anzupgo was launched by Leo in 2025.
Approval Date:
Anzupgo was approved by FDA for market use on 23 July, 2025.
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 Anzupgo is 23 July, 2025, its NCE-1 date is estimated to be 23 July, 2029.
Active Ingredient:
Anzupgo uses Delgocitinib as the active ingredient. Check out other Drugs and Companies using Delgocitinib ingredient
Dosage:
Anzupgo is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | CREAM | Prescription | TOPICAL |
