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Last Updated: July 2, 2020

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VYONDYS 53 Drug 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 one hundred and twenty-four patent family members in eighteen 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.

US ANDA Litigation and 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.

Indicators of Generic Entry

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Summary for VYONDYS 53
International Patents:124
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:VYONDYS 53 at DailyMed
Drug patent expirations by year for VYONDYS 53
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

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Merck
Medtronic
Harvard Business School
Mallinckrodt

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