Vyondys 53 is a drug owned by Sarepta Therapeutics Inc. It is protected by 10 US drug patents filed from 2019 to 2021. Out of these, 8 drug patents are active and 2 have expired. Vyondys 53's patents have been open to challenges since 13 December, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2028. Details of Vyondys 53'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. | |||
| US9994851 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US9024007 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US10421966 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US10227590 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US10968450 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US9416361 | Splice-region antisense composition and method |
May, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE47691 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2028
(3 years from now) | Active |
| US10266827 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US10995337 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(8 months from now) | Active |
| US10533174 | Splice-region antisense composition and method |
May, 2021
(3 years ago) |
Expired
|
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 Vyondys 53's patents.
Latest Legal Activities on Vyondys 53's Patents
Given below is the list of recent legal activities going on the following patents of Vyondys 53.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Withdrawal of Application for PTE Critical | 07 Mar, 2024 | US9024007 |
| Withdrawal of Application for PTE Critical | 07 Mar, 2024 | US10421966 |
| Withdrawal of Application for PTE Critical | 07 Mar, 2024 | US9994851 |
| Withdrawal of Application for PTE Critical | 07 Mar, 2024 | US10266827 |
| Withdrawal of Application for PTE Critical | 07 Mar, 2024 | US10227590 |
| Notice of Final Determination -Election Required | 18 Jul, 2023 | US10266827 |
| Notice of Final Determination -Election Required | 18 Jul, 2023 | US10421966 |
| Notice of Final Determination -Election Required | 18 Jul, 2023 | US9024007 |
| Notice of Final Determination -Election Required | 18 Jul, 2023 | US10227590 |
| Notice of Final Determination -Election Required | 18 Jul, 2023 | US9994851 |
FDA has granted several exclusivities to Vyondys 53. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyondys 53, 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 Vyondys 53.
Exclusivity Information
Vyondys 53 holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Vyondys 53's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2024 |
| Orphan Drug Exclusivity(ODE-280) | Dec 12, 2026 |
Several oppositions have been filed on Vyondys 53'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 Vyondys 53's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vyondys 53 patents.
Vyondys 53's Oppositions Filed in EPO
Vyondys 53 has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 25, 2016, by Nippon Shinyaku Co., Ltd.. This opposition was filed on patent number EP10004274A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10004274A | Aug, 2016 | Nippon Shinyaku Co., Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Vyondys 53 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 Vyondys 53's family patents as well as insights into ongoing legal events on those patents.
Vyondys 53's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vyondys 53's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 28, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyondys 53 Generics:
There are no approved generic versions for Vyondys 53 as of now.
About Vyondys 53
Vyondys 53 is a drug owned by Sarepta Therapeutics Inc. It is used for treating Duchenne Muscular Dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. Vyondys 53 uses Golodirsen as an active ingredient. Vyondys 53 was launched by Sarepta Theraps Inc in 2019.
Approval Date:
Vyondys 53 was approved by FDA for market use on 12 December, 2019.
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 Vyondys 53 is 12 December, 2019, its NCE-1 date is estimated to be 13 December, 2023.
Active Ingredient:
Vyondys 53 uses Golodirsen as the active ingredient. Check out other Drugs and Companies using Golodirsen ingredient
Treatment:
Vyondys 53 is used for treating Duchenne Muscular Dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
Dosage:
Vyondys 53 is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/2ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |