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-one 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
*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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Jun 2, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 23, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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