Details for New Drug Application (NDA): 205718
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NDA 205718 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 205718
| Tradename: | AKYNZEO |
| Applicant: | Helsinn Hlthcare |
| Ingredient: | netupitant; palonosetron hydrochloride |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205718
*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: 205718
Suppliers and Packaging for NDA: 205718
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-101 | 69639-101-01 | 1 BLISTER PACK in 1 CARTON (69639-101-01) / 1 CAPSULE in 1 BLISTER PACK |
| AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-101 | 69639-101-04 | 2 BLISTER PACK in 1 CARTON (69639-101-04) / 2 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;EQ 0.5MG BASE | ||||
| Approval Date: | Oct 10, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 25, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 25, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 17, 2030 | 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 CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY | ||||||||
Expired US Patents for NDA 205718
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Helsinn Hlthcare | AKYNZEO | netupitant; palonosetron hydrochloride | CAPSULE;ORAL | 205718-001 | Oct 10, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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