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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206488

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NDA 206488 describes EXONDYS 51, which is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the EXONDYS 51 profile page.

The generic ingredient in EXONDYS 51 is eteplirsen. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.
Summary for 206488
Tradename:EXONDYS 51
Applicant:Sarepta Theraps Inc
Ingredient:eteplirsen
Patents:5
Generic Entry Opportunity Date for 206488
Generic Entry Date for 206488*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;IV (INFUSION)

*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: 206488
Suppliers and Packaging for NDA: 206488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488 NDA Sarepta Therapeutics, Inc. 60923-284 60923-284-10 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) > 10 mL in 1 VIAL, SINGLE-USE
EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488 NDA Sarepta Therapeutics, Inc. 60923-363 60923-363-02 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) > 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/2ML (50MG/ML)
Approval Date:Sep 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 19, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 19, 2023
Regulatory Exclusivity Use:TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Patent:➤ Sign UpPatent Expiration:Jun 28, 2025Product Flag?Substance Flag?Delist Request?Y
Patented Use:(I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

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