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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218571


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NDA 218571 describes CARDAMYST, which is a drug marketed by Milestone Pharms Usa 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 CARDAMYST profile page.

The generic ingredient in CARDAMYST is etripamil. One supplier is listed for this compound. Additional details are available on the etripamil profile page.
Summary for 218571
Tradename:CARDAMYST
Applicant:Milestone Pharms Usa
Ingredient:etripamil
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218571
Generic Entry Date for 218571*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SPRAY;NASAL

*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.

Suppliers and Packaging for NDA: 218571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDAMYST etripamil SPRAY;NASAL 218571 NDA Milestone Pharmaceuticals USA, Inc. 83468-070 83468-070-03 2 CONTAINER in 1 CARTON (83468-070-03) / 2 VIAL, SINGLE-DOSE in 1 CONTAINER (83468-070-02) / .2 mL in 1 VIAL, SINGLE-DOSE (83468-070-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength70MG
Approval Date:Dec 12, 2025TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2030
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:10,010,522Patent Expiration:Jun 19, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
Patent:10,010,523Patent Expiration:Jun 19, 2028Product Flag?Substance Flag?YDelist Request?

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