Viltepso is a drug owned by Nippon Shinyaku Co Ltd. It is protected by 2 US drug patents filed from 2020 to 2021 out of which none have expired yet. Viltepso's patents have been open to challenges since 12 August, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 31, 2031. Details of Viltepso'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. | |||
| US10870676 | Antisense nucleic acids |
Aug, 2031
(5 years from now) | Active |
| US9079934 | Antisense nucleic acids |
Aug, 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 Viltepso's patents.
Latest Legal Activities on Viltepso's Patents
Given below is the list of recent legal activities going on the following patents of Viltepso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2024 | US10870676 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US9079934 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9079934 |
| Second letter to regulating agency to determine regulatory review period | 26 Jan, 2023 | US9079934 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Dec, 2022 | US9079934 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 21 Dec, 2022 | US9079934 |
| Email Notification
Critical | 21 Dec, 2022 | US9079934 |
| Email Notification
Critical | 14 Nov, 2022 | US10870676 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 14 Nov, 2022 | US10870676 |
| Correspondence Address Change
Critical | 30 Sep, 2022 | US10870676 |
FDA has granted several exclusivities to Viltepso. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Viltepso, 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
Viltepso.
Exclusivity Information
Viltepso holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Viltepso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 12, 2025 |
| Orphan Drug Exclusivity(ODE-280) | Aug 12, 2027 |
Several oppositions have been filed on Viltepso's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Viltepso's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Viltepso patents.
Viltepso's Oppositions Filed in EPO
Viltepso has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 06, 2020, by Sarepta Therapeutics. This opposition was filed on patent number EP15199455A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15199455A | May, 2020 | James Poole Limited | Revoked |
| EP15199455A | May, 2020 | Sarepta Therapeutics | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Viltepso 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 Viltepso's family patents as well as insights into
ongoing legal events
on those patents.
Viltepso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Viltepso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 31, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Viltepso Generics:
There are no approved generic versions for Viltepso as of now.
About Viltepso
Viltepso is a drug owned by Nippon Shinyaku Co Ltd. It is used for treating Duchenne Muscular Dystrophy in patients with a confirmed mutation that can be treated with exon 53 skipping. Viltepso uses Viltolarsen as an active ingredient. Viltepso was launched by Nippon Shinyaku in 2020.
Approval Date:
Viltepso was approved by FDA for market use on 12 August, 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 Viltepso is 12 August, 2020, its NCE-1 date is estimated to be 12 August, 2024.
Active Ingredient:
Viltepso uses Viltolarsen as the active ingredient. Check out other Drugs and Companies using Viltolarsen ingredient
Treatment:
Viltepso is used for treating Duchenne Muscular Dystrophy in patients with a confirmed mutation that can be treated with exon 53 skipping.
Dosage:
Viltepso is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/5ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |