Details for New Drug Application (NDA): 218571
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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: | 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? | ||
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