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Last Updated: May 24, 2022

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 twenty-eight 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 will be eligible for patent challenges on December 12, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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 has been one patent litigation case 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:28
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 Generic Entry Opportunity 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.

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 See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VYONDYS 53

When does loss-of-exclusivity occur for VYONDYS 53?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 8685
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110352
Estimated Expiration: See Plans and Pricing

Patent: 0160225
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11447
Estimated Expiration: See Plans and Pricing

Patent: 17475
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 66010
Estimated Expiration: See Plans and Pricing

Patent: 06781
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 66010
Estimated Expiration: See Plans and Pricing

Patent: 06781
Estimated Expiration: See Plans and Pricing

Patent: 05200
Estimated Expiration: See Plans and Pricing

Patent: 00430
Estimated Expiration: See Plans and Pricing

Patent: 33332
Estimated Expiration: See Plans and Pricing

Patent: 29142
Estimated Expiration: See Plans and Pricing

Patent: 28711
Estimated Expiration: See Plans and Pricing

Patent: 08845
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005026386
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 16545
Estimated Expiration: See Plans and Pricing

Patent: 45325
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28632
Estimated Expiration: See Plans and Pricing

Poland

Patent: 66010
Estimated Expiration: See Plans and Pricing

Patent: 06781
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 66010
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 66010
Estimated Expiration: See Plans and Pricing

Patent: 06781
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61325
Estimated Expiration: See Plans and Pricing

Patent: 64185
Estimated Expiration: See Plans and Pricing

Patent: 27917
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Portugal 1766012 See Plans and Pricing
European Patent Office 3228711 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) See Plans and Pricing
Spain 2361325 See Plans and Pricing
Denmark 2024499 See Plans and Pricing
>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. 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.