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Last Updated: April 17, 2021

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Details for New Drug Application (NDA): 211970

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NDA 211970 describes VYONDYS 53, which is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the VYONDYS 53 profile page.

The generic ingredient in VYONDYS 53 is golodirsen. One supplier is listed for this compound. Additional details are available on the golodirsen profile page.
Summary for 211970
Tradename:VYONDYS 53
Applicant:Sarepta Theraps Inc
Ingredient:golodirsen
Patents:8
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 211970
Generic Entry Date for 211970*:
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
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.

Suppliers and Packaging for NDA: 211970
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970 NDA Sarepta Therapeutics, Inc. 60923-465 60923-465-02 1 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) > 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/2ML (50MG/ML)
Approval Date:Dec 12, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2026
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Dec 12, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jun 28, 2025Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Colorcon
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Johnson and Johnson
Baxter
AstraZeneca
Moodys

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