Details for New Drug Application (NDA): 210493
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NDA 210493 describes AKYNZEO, which is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are twenty patents protecting this drug. Additional details are available on the AKYNZEO profile page.
The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.
The generic ingredient in AKYNZEO is fosnetupitant chloride hydrochloride; palonosetron hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fosnetupitant chloride hydrochloride; palonosetron hydrochloride profile page.
Summary for 210493
| Tradename: | AKYNZEO |
| Applicant: | Helsinn Hlthcare |
| Ingredient: | fosnetupitant chloride hydrochloride; palonosetron hydrochloride |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210493
Generic Entry Date for 210493*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 210493
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 210493
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | POWDER;INTRAVENOUS | 210493 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-102 | 69639-102-01 | 1 VIAL in 1 CARTON (69639-102-01) / 1 INJECTION in 1 VIAL |
| AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-102 | 69639-102-01 | 1 VIAL in 1 CARTON (69639-102-01) / 1 INJECTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | ||||
| Approval Date: | Apr 19, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 23, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 2, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 23, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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