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Last Updated: November 4, 2024

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 nine 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:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206488
Generic Entry Date for 206488*:
Constraining patent/regulatory exclusivity:
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: 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
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Expired US Patents for NDA 206488

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 ⤷  Sign Up ⤷  Sign Up
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 ⤷  Sign Up ⤷  Sign Up
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 ⤷  Sign Up ⤷  Sign Up
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.