Artesunate Patent Expiration

Artesunate was first introduced by Amivas Inc in its drug Artesunate on May 26, 2020.


Artesunate Patents

Given below is the list of patents protecting Artesunate, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Artesunate US12121506 Artesunate powders, pharmaceutical compositions and methods of manufacture Feb 16, 2044 Amivas
Artesunate US12390442 Feb 16, 2044 Amivas



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Artesunate's patents.

Given below is the list recent legal activities going on the following patents of Artesunate.

Activity Date Patent Number
Patent litigations
Patent eGrant Notification 22 Oct, 2024 US12121506
Mail Patent eGrant Notification 22 Oct, 2024 US12121506
Email Notification 22 Oct, 2024 US12121506
Recordation of Patent Grant Mailed 22 Oct, 2024 US12121506
Recordation of Patent eGrant 22 Oct, 2024 US12121506
Patent Issue Date Used in PTA Calculation 22 Oct, 2024 US12121506
Email Notification 02 Oct, 2024 US12121506
Issue Notification Mailed 02 Oct, 2024 US12121506
Dispatch to FDC 19 Sep, 2024 US12121506
Application Is Considered Ready for Issue 19 Sep, 2024 US12121506


Artesunate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Artesunate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial Muhimbili University of Health and Allied Sciences NA COMPLETED
(Sep 1, 2026)
PHASE2, PHASE3
ArtemiCoffee in Patients With Rising PSA Zin W Myint NA COMPLETED
(Aug 1, 2026)
PHASE2
Dose-Escalation Study of Artesunate Patients With IPF Joseph C. Wu NA RECRUITING
(Aug 1, 2026)
PHASE1
Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar London School of Hygiene and Tropical Medicine NA RECRUITING
(Aug 1, 2026)
PHASE3
A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults University of Oxford NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Study Evaluating the Efficacy and Safety of Artesunate Amivas Inc. NA RECRUITING
(Jul 1, 2026)
PHASE2
FocaL Mass Drug Administration for Vivax Malaria Elimination University of California, San Francisco NA RECRUITING
(Jun 1, 2026)
PHASE3
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya UNC Lineberger Comprehensive Cancer Center NA COMPLETED
(May 1, 2026)
PHASE2
A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension Joseph C. Wu NA RECRUITING
(Apr 1, 2026)
PHASE1
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria Novartis Pharmaceuticals NA COMPLETED
(Mar 1, 2026)
PHASE2
Controlled Human Malaria Infection by Mosquito Bites Using a Local Strain of Plasmodium Falciparum Centre de Recherche Médicale de Lambaréné NA COMPLETED
(Mar 1, 2026)
PHASE1


Artesunate Generic API Manufacturers

Given below is the list of companies who have filed for Artesunate generic, along with the locations of their manufacturing plants worldwide.