Artesunate is a drug owned by Amivas Inc. It is protected by 1 US drug patent filed in 2024 out of which none have expired yet. Artesunate's patents have been open to challenges since 26 May, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 16, 2044. Details of Artesunate's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12121506 | Artesunate powders, pharmaceutical compositions and methods of manufacture |
Feb, 2044
(19 years from now) | Active |
FDA has granted several exclusivities to Artesunate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Artesunate, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Artesunate.
Exclusivity Information
Artesunate holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Artesunate's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 26, 2025 |
| Orphan Drug Exclusivity(ODE-290) | May 26, 2027 |
US patents provide insights into the exclusivity only within the United States, but Artesunate is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Artesunate's family patents as well as insights into ongoing legal events on those patents.
Artesunate's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Artesunate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 16, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Artesunate Generics:
There are no approved generic versions for Artesunate as of now.
About Artesunate
Artesunate is a drug owned by Amivas Inc. Artesunate uses Artesunate as an active ingredient. Artesunate was launched by Amivas in 2020.
Approval Date:
Artesunate was approved by FDA for market use on 26 May, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Artesunate is 26 May, 2020, its NCE-1 date is estimated to be 26 May, 2024.
Active Ingredient:
Artesunate uses Artesunate as the active ingredient. Check out other Drugs and Companies using Artesunate ingredient
Dosage:
Artesunate is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 110MG/VIAL | POWDER | Prescription | INTRAVENOUS |