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 Loss of Exclusivity (LOE) Date for 211970

Generic Entry Date for 211970^: ⤷ Subscribe* 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.

Pharmacology for NDA: 211970

Physiological Effect	Increased Protein Synthesis

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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/2ML (50MG/ML)
Approval Date:	Dec 12, 2019	TE:		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:	⤷ Subscribe	Patent Expiration:	Jun 28, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 211970

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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	⤷ Subscribe	⤷ Subscribe
Sarepta Theraps Inc	VYONDYS 53	golodirsen	SOLUTION;INTRAVENOUS	211970-001	Dec 12, 2019	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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