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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Questions you can ask:
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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 |
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
Drug Class | Antisense Oligonucleotide |
Physiological Effect | Increased Protein Synthesis |
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 |
Expired US Patents for VYONDYS 53
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |