Vyondys 53 Patent Expiration

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. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 12, 2026. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9416361 Splice-region antisense composition and method
May, 2021

(3 years ago)

Expired
US10227590 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US10968450 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US9024007 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US10421966 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US9994851 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10533174 Splice-region antisense composition and method
May, 2021

(3 years ago)

Expired
USRE47691 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US10995337 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active
US10266827 Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(11 months from now)

Active


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

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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
Patent litigations
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

Vyondys 53 has patent protection in a total of 14 countries. It has a significant patent presence in the US with 63.9% of its patents being US patents. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vyondys 53.

Family Patents

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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 Dec 12, 2026 (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.

Market Authorisation Date:

Vyondys 53 was approved by FDA for market use on 12 December, 2019.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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