Amphotericin B Patent Expiration

Amphotericin B was first introduced by Apothecon Inc Div Bristol Myers Squibb in its drug Fungizone on Approved Prior to Jan 1, 1982. Other drugs containing Amphotericin B are Ambisome, Amphotec, Abelcet. 13 different companies have introduced drugs containing Amphotericin B.


Amphotericin B Patents

Given below is the list of patents protecting Amphotericin B, 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
Abelcet US6406713 Methods of preparing low-toxicity drug-lipid complexes Jun 18, 2019

(Expired)

Leadiant Biosci Inc
Ambisome US5965156 Amphotericin B liposome preparation Oct 12, 2016

(Expired)

Astellas
Ambisome US5874104 Treatment of systemic fungal infections with phospholipid particles encapsulating polyene antibiotics Feb 23, 2016

(Expired)

Astellas
Abelcet US5616334 Low toxicity drug-lipid systems Apr 01, 2014

(Expired)

Leadiant Biosci Inc



Amphotericin B's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Amphotericin B:

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
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh NA RECRUITING
(Sep 1, 2026)
PHASE3
Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT) University of Minnesota NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST) Duke University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) Radboud University Medical Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
RB-PDT for Fusarium Keratitis: The LUMIERE Study Stanford University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS Federal University of Health Science of Porto Alegre NA RECRUITING
(Jul 1, 2026)
PHASE3
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement Rush University Medical Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM) David Boulware NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options Mundipharma Research Limited NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy Elion Therapeutics, Inc. NA RECRUITING
(May 1, 2026)
PHASE2
Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease Assistance Publique - Hôpitaux de Paris NA RECRUITING
(Mar 1, 2026)
PHASE2
Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) Institute of Tropical Medicine, Belgium NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3


Amphotericin B Generic API Manufacturers

Several generic applications have been filed for Amphotericin B. The first generic version for Amphotericin B was by Apothecon Inc Div Bristol Myers Squibb and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Mylan Laboratories Ltd and was approved on Jun 30, 2025.

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