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Last Updated: January 29, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213026


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NDA 213026 describes AMONDYS 45, 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 AMONDYS 45 profile page.

The generic ingredient in AMONDYS 45 is casimersen. One supplier is listed for this compound. Additional details are available on the casimersen profile page.
Summary for 213026
Tradename:AMONDYS 45
Applicant:Sarepta Theraps Inc
Ingredient:casimersen
Patents:8
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213026
Generic Entry Date for 213026*:
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: 213026
Physiological Effect Increased Protein Synthesis
Suppliers and Packaging for NDA: 213026
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026 NDA Sarepta Therapeutics, Inc. 60923-227 60923-227-02 1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) > 2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/2ML (50MG/ML)
Approval Date:Feb 25, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 25, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 25, 2028
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 45 SKIPPING
Patent:⤷  Try it FreePatent Expiration:Nov 12, 2030Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 213026

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 ⤷  Try it Free ⤷  Try it Free
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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