VYONDYS 53 Drug Patent Profile
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Which patents cover Vyondys 53, and what generic alternatives are available?
Vyondys 53 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There is one patent 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: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYONDYS 53 |
US Patents and Regulatory Information for VYONDYS 53
VYONDYS 53 is protected by one US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYONDYS 53 is ⤷ Start Trial.
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.
| 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 | RE47691 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 |
|---|---|---|---|
| Austria | E498685 | ⤷ Start Trial | |
| Cyprus | 1111447 | ⤷ Start Trial | |
| Cyprus | 1117475 | ⤷ Start Trial | |
| Germany | 602005026386 | ⤷ Start Trial | |
| Denmark | 1766010 | ⤷ Start Trial | |
| Denmark | 2206781 | ⤷ Start Trial | |
| 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) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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