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Profile for Tradename: ABELCET

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Abelcet is a drug marketed by Sigma Tau and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

This drug has forty-six patent family members in twenty-four countries.

The generic ingredient in ABELCET is amphotericin b. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

Summary for Tradename: ABELCET

Suppliers / Packagers: see list1

Pharmacology for Tradename: ABELCET

Clinical Trials for: ABELCET

Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia
Status: Completed Condition: Invasive Pulmonary Aspergillosis; Lymphoblastic Leukaemia; Myeloblastic Leukaemia; Lymphoblastic Leukemia; Myeloblastic Leukemia

Phase III, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis in Bangladesh
Status: Recruiting Condition: Visceral Leishmaniasis

To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
Status: Completed Condition: Leishmaniasis, Visceral

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Status: Completed Condition: Visceral Leishmaniasis

Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Status: Terminated Condition: Febrile Neutropenia

Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis
Status: Terminated Condition: Visceral Leishmaniasis

Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Status: Completed Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Liposomal Amphotericin in Disseminated Leishmaniasis
Status: Completed Condition: Disseminated Leishmaniasis

Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
Status: Active, not recruiting Condition: Visceral Leishmaniasis

Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Status: Completed Condition: Liver Disease; Fungal Infection

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigma Tau
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713<disabled>Y <disabled>
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Non-Orange Book Patents for Tradename: ABELCET

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
4,963,297 Spontaneous vesticulation of multilamellar liposomes<disabled in preview>
5,948,441 Method for size separation of particles<disabled in preview>
5,616,334 Low toxicity drug-lipid systems<disabled in preview>
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International Patent Family for Tradename: ABELCET

Country Document Number Publication Date
New Zealand223660Nov 27, 1990
European Patent Office0394265Nov 02, 1994
Norway884391Oct 04, 1988
Canada1330199Jun 14, 1994
Finland102724Feb 15, 1999
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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