Artesunate - Generic Drug Details
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What are the generic drug sources for artesunate and what is the scope of patent protection?
Artesunate
is the generic ingredient in one branded drug marketed by Amivas and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for artesunate. One supplier is listed for this compound.
Summary for artesunate
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 152 |
| Clinical Trials: | 225 |
| Patent Applications: | 1,913 |
| Drug Prices: | Drug price trends for artesunate |
| What excipients (inactive ingredients) are in artesunate? | artesunate excipients list |
| DailyMed Link: | artesunate at DailyMed |
Recent Clinical Trials for artesunate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Uppsala University | Phase 2/Phase 3 |
| The Swedish Research Council | Phase 2/Phase 3 |
| Muhimbili University of Health and Allied Sciences | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for artesunate
US Patents and Regulatory Information for artesunate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amivas | ARTESUNATE | artesunate | POWDER;INTRAVENOUS | 213036-001 | May 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amivas | ARTESUNATE | artesunate | POWDER;INTRAVENOUS | 213036-001 | May 26, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for artesunate
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Amivas Ireland Ltd | Artesunate Amivas | artesunate | EMEA/H/C/005550 Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.Consideration should be given to official guidance on the appropriate use of antimalarial agents. |
Authorised | no | no | yes | 2021-11-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
