Details for New Drug Application (NDA): 218571
✉ Email this page to a colleague
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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the etripamil profile page.
The generic ingredient in CARDAMYST is etripamil. There is one drug master file entry for this compound. 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: | RX | Dosage: | SPRAY;NASAL | Strength | 70MG | ||||
| Approval Date: | Dec 12, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 12, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,010,522 | Patent Expiration: | Jun 19, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA | ||||||||
| Patent: | 10,010,523 | Patent Expiration: | Jun 19, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Complete Access Available with Subscription
