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^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: ⤷ Get Started Free 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:	⤷ Get Started Free	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	⤷ Get Started Free	⤷ Get Started Free
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021	⤷ Get Started Free	⤷ Get Started Free
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021	⤷ Get Started Free	⤷ Get Started Free
>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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.