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 six 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:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213026

Generic Entry Date for 213026^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/2ML (50MG/ML)
Approval Date:	Feb 25, 2021	TE:		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:	⤷ Sign Up	Patent Expiration:	Nov 12, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 213026

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

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