Details for New Drug Application (NDA): 214375
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NDA 214375 describes XENOVIEW, which is a drug marketed by Polarean and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the XENOVIEW profile page.
The generic ingredient in XENOVIEW is xenon xe-129 hyperpolarized. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the xenon xe-129 hyperpolarized profile page.
The generic ingredient in XENOVIEW is xenon xe-129 hyperpolarized. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the xenon xe-129 hyperpolarized profile page.
Summary for 214375
| Tradename: | XENOVIEW |
| Applicant: | Polarean |
| Ingredient: | xenon xe-129 hyperpolarized |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214375
Generic Entry Date for 214375*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
GAS;INHALATION |
*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: 214375
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 214375
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XENOVIEW | xenon xe-129 hyperpolarized | GAS;INHALATION | 214375 | NDA | Polarean, Inc. | 80534-0300 | 80534-0300-1 | 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG |
| XENOVIEW | xenon xe-129 hyperpolarized | GAS;INHALATION | 214375 | NDA | Polarean, Inc. | 80534-0500 | 80534-0500-1 | 50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | N/A | ||||
| Approval Date: | Dec 23, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 20, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Dec 29, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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