Abelcet Patent Expiration

Abelcet is a drug owned by Leadiant Biosciences Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 18, 2019. Details of Abelcet's patents and their expiration are given in the table below.

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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).
US6406713 Methods of preparing low-toxicity drug-lipid complexes
Jun, 2019

(7 years ago)

Expired
US5616334 Low toxicity drug-lipid systems
Apr, 2014

(12 years ago)

Expired


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Abelcet and ongoing litigations to help you estimate the early arrival of Abelcet generic.

Abelcet's Litigations

Abelcet been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 30, 2001, against patent number US6406713. The petitioner , challenged the validity of this patent, with JANOFF et al as the respondent. Click below to track the latest information on how companies are challenging Abelcet's patents.

Last updated on October 6, 2026
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6406713 March, 2001 Decision
(19 Dec, 2001)
JANOFF et al

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US patents provide insights into the exclusivity only within the United States, but Abelcet 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 Abelcet's family patents as well as insights into ongoing legal events on those patents.

Abelcet's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Abelcet:

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




Generic Launch

Generic Release Date:

Abelcet's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 18, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Abelcet Generic API suppliers:

Amphotericin B is the generic name for the brand Abelcet. 9 different companies have already filed for the generic of Abelcet, with Apothecon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abelcet's generic

Alternative Brands for Abelcet

There are several other brand drugs using the same active ingredient (Amphotericin B) as Abelcet. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Astellas
Ambisome


Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphotericin B, Abelcet's active ingredient. Check the complete list of approved generic manufacturers for Abelcet





About Abelcet

Abelcet is a drug owned by Leadiant Biosciences Inc. Abelcet uses Amphotericin B as an active ingredient. Abelcet was launched by Leadiant Biosci in 1995.

Approval Date:

Abelcet was approved by FDA for market use on 20 November, 1995.

Active Ingredient:

Abelcet uses Amphotericin B as the active ingredient. Check out other Drugs and Companies using Amphotericin B ingredient

Dosage:

Abelcet is available in injectable, lipid complex form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
5MG/ML INJECTABLE, LIPID COMPLEX Discontinued INJECTION