ARTESUNATE Drug Patent Profile
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When do Artesunate patents expire, and when can generic versions of Artesunate launch?
Artesunate is a drug marketed by Amivas and is included in one NDA.
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Artesunate
A generic version of ARTESUNATE was approved as artesunate by AMIVAS on May 26th, 2020.
Summary for ARTESUNATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 152 |
| Clinical Trials: | 225 |
| Patent Applications: | 839 |
| Drug Prices: | Drug price information 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
ARTESUNATE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting ARTESUNATE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
