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Last Updated: November 7, 2024

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VYONDYS 53 Drug Patent Profile


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When do Vyondys 53 patents expire, and when can generic versions of Vyondys 53 launch?

Vyondys 53 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are eight patents protecting this drug.

This drug has thirty patent family members in thirteen countries.

The generic ingredient in VYONDYS 53 is golodirsen. One supplier is listed for this compound. Additional details are available on the golodirsen profile page.

DrugPatentWatch® Generic Entry Outlook for Vyondys 53

Vyondys 53 was eligible for patent challenges on December 12, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2026. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for VYONDYS 53
International Patents:30
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for VYONDYS 53
What excipients (inactive ingredients) are in VYONDYS 53?VYONDYS 53 excipients list
DailyMed Link:VYONDYS 53 at DailyMed
Drug patent expirations by year for VYONDYS 53
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VYONDYS 53
Generic Entry Date for VYONDYS 53*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VYONDYS 53

US Patents and Regulatory Information for VYONDYS 53

VYONDYS 53 is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYONDYS 53 is ⤷  Sign Up.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYONDYS 53

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting VYONDYS 53

INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VYONDYS 53

See the table below for patents covering VYONDYS 53 around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2007103529 ⤷  Sign Up
Spain 2564185 ⤷  Sign Up
European Patent Office 3029142 OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) ⤷  Sign Up
European Patent Office 2024499 ANALOGUES D'OLIGONUCLÉOTIDES AYANT DES LIAISONS CATIONIQUES ENTRE LES SOUS-UNITÉS (OLIGONUCLEOTIDE ANALOGS HAVING CATIONIC INTERSUBUNIT LINKAGES) ⤷  Sign Up
Canada 2584873 COMPOSES ANTIVIRAUX ANTISENS ET METHODES DE TRAITEMENT D'INFECTION PAR UN FILOVIRUS (ANTISENSE ANTIVIRAL COMPOUNDS AND METHODS FOR TREATING A FILOVIRUS INFECTION) ⤷  Sign Up
European Patent Office 1704243 COMPOSE OLIGONUCLEOTIDIQUE ET METHODE DE TRAITEMENT D'INFECTIONS PAR NIDOVIRUS (OLIGONUCLEOTIDE COMPOUND AND METHOD FOR TREATING NIDOVIRUS INFECTIONS) ⤷  Sign Up
European Patent Office 1766010 OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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