Zelsuvmi is a drug owned by Lnhc Inc. It is protected by 14 US drug patents filed in 2024 out of which none have expired yet. Zelsuvmi's patents will be open to challenges from 06 January, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 10, 2035. Details of Zelsuvmi'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. | |||
| US8956658 | Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications |
May, 2026
(6 months from now) | Active |
| US8282967 | Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications |
May, 2026
(6 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). | |||
| US10322081 | Topical antiviral compositions and methods of using the same |
Jul, 2035
(9 years from now) | Active |
| US10736839 | Topical antiviral compositions, delivery systems, and methods of using the same |
Jul, 2035
(9 years from now) | Active |
| US11040006 | Topical antiviral compositions, delivery systems, and methods of using the same |
Jul, 2035
(9 years from now) | Active |
| US11723858 | Topical antiviral compositions, delivery systems, and methods of using the same |
Jul, 2035
(9 years from now) | Active |
| US10258564 | Topical compositions and methods of using the same |
Nov, 2034
(9 years from now) | Active |
| US11285098 | Topical compositions and methods of using the same |
Feb, 2034
(8 years from now) | Active |
| US9855211 | Topical compositions and methods of using the same |
Feb, 2034
(8 years from now) | Active |
| US10265334 | Anhydrous compositions |
Jul, 2032
(6 years from now) | Active |
| US9289442 | Topical compositions |
Jul, 2032
(6 years from now) | Active |
| US9526738 | Topical gels and methods of using the same |
Sep, 2031
(5 years from now) | Active |
| US10376538 | Topical gels and methods of using the same |
Aug, 2030
(4 years from now) | Active |
| US9737561 | Topical gels and methods of using the same |
Aug, 2030
(4 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 Zelsuvmi's patents.
Latest Legal Activities on Zelsuvmi's Patents
Given below is the list of recent legal activities going on the following patents of Zelsuvmi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 27 Jun, 2024 | US9526738 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 22 Mar, 2024 | US8282967 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 05 Mar, 2024 | US9855211 |
| Email Notification
Critical | 05 Mar, 2024 | US9855211 |
| Initial letter Re: PTE Application to regulating agency | 04 Mar, 2024 | US9855211 |
| Patent Term Extension Application under 35 USC 156 Filed | 01 Mar, 2024 | US9855211 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 12 Feb, 2024 | US10736839 |
| Patent Issue Date Used in PTA Calculation
Critical | 15 Aug, 2023 | US11723858 |
| Email Notification
Critical | 15 Aug, 2023 | US11723858 |
| Mail Patent eGrant Notification | 15 Aug, 2023 | US11723858 |
FDA has granted several exclusivities to Zelsuvmi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Zelsuvmi, 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
Zelsuvmi.
Exclusivity Information
Zelsuvmi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Zelsuvmi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 05, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Zelsuvmi 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 Zelsuvmi's family patents as well as insights into
ongoing legal events
on those patents.
Zelsuvmi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zelsuvmi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 10, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zelsuvmi Generics:
There are no approved generic versions for Zelsuvmi as of now.
About Zelsuvmi
Zelsuvmi is a drug owned by Lnhc Inc. It is used for treating viral infections, dermatological conditions, and malignant lesions, as well as improving skin ailments. Zelsuvmi uses Berdazimer Sodium as an active ingredient. Zelsuvmi was launched by Lnhc in 2024.
Approval Date:
Zelsuvmi was approved by FDA for market use on 05 January, 2024.
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 Zelsuvmi is 05 January, 2024, its NCE-1 date is estimated to be 06 January, 2028.
Active Ingredient:
Zelsuvmi uses Berdazimer Sodium as the active ingredient. Check out other Drugs and Companies using Berdazimer Sodium ingredient
Treatment:
Zelsuvmi is used for treating viral infections, dermatological conditions, and malignant lesions, as well as improving skin ailments.
Dosage:
Zelsuvmi is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10.3% BASE | GEL | Prescription | TOPICAL |