Details for New Drug Application (NDA): 215168
✉ Email this page to a colleague
NDA 215168 describes FLYRCADO, which is a drug marketed by Ge Hlthcare 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 FLYRCADO profile page.
The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. Additional details are available on the flurpiridaz f-18 profile page.
The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. Additional details are available on the flurpiridaz f-18 profile page.
Summary for 215168
| Tradename: | FLYRCADO |
| Applicant: | Ge Hlthcare |
| Ingredient: | flurpiridaz f-18 |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215168
Generic Entry Date for 215168*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 215168
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 215168
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLYRCADO | flurpiridaz f-18 | SOLUTION;INTRAVENOUS | 215168 | NDA | GE Healthcare Inc. | 0407-8787 | 0407-8787-01 | 30 mL in 1 VIAL, GLASS (0407-8787-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5-55mCi/ML | ||||
| Approval Date: | Sep 27, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 26, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jun 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING | ||||||||
Complete Access Available with Subscription
