Details for New Drug Application (NDA): 213036
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NDA 213036 describes ARTESUNATE, which is a drug marketed by Amivas 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 ARTESUNATE profile page.
The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artesunate profile page.
The generic ingredient in ARTESUNATE is artesunate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artesunate profile page.
Summary for 213036
| Tradename: | ARTESUNATE |
| Applicant: | Amivas |
| Ingredient: | artesunate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213036
Generic Entry Date for 213036*:
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.
Suppliers and Packaging for NDA: 213036
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARTESUNATE | artesunate | POWDER;INTRAVENOUS | 213036 | NDA | Amivas, Inc | 73607-011 | 73607-011-11 | 2 KIT in 1 CARTON (73607-011-11) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (73607-002-01) * 1 SOLUTION in 1 VIAL (73607-003-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 110MG/VIAL | ||||
| Approval Date: | May 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE INITIAL TREATMENT OF SEVERE MALARIA IN ADULT AND PEDIATRIC PATIENTS TO ALWAYS BE FOLLOWED BY A COMPLETE TREATMENT COURSE OF AN APPROPRIATE ORAL ANTIMALARIAL REGIMEN | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 16, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 16, 2044 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING MALARIA USING MICRONIZED POWDER OF CRYSTALLINE ARTESUNATE PREPARED BY STERILIZING AND FILLING THE POWDER INTO A CONTAINER AT A RELATIVE HUMIDITY OF 30 TO 40%, MIXING THE POWDER WITH A BUFFER AND ADMINISTERING THE COMPOSITION | ||||||||
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