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Details for Generic Name: amphotericin b

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Amphotericin b is the generic ingredient in five branded drugs marketed by Apothecon, Sigma Tau, Alkopharma Usa, Astellas, Abbott, Abraxis Pharm, Teva Parenteral, X Gen Pharms, and Bristol Myers Squibb, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-two patent family members in twenty-four countries.

There are fifteen drug master file entries for amphotericin b. Three suppliers are listed for this compound.

Summary for Generic Name: amphotericin b

Tradenames:5
Patents:3
Applicants:9
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packaging: see list4

Pharmacology for Ingredient: amphotericin b

Clinical Trials for: amphotericin b

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

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

Courtesy of ClinicalTrials.org
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
Apothecon
FUNGIZONE
amphotericin b
OINTMENT;TOPICAL050313-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Apothecon
FUNGIZONE
amphotericin b
LOTION;TOPICAL060570-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,965,156<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: amphotericin b

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 19955,616,334<disabled>
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International Patent Family for Ingredient: amphotericin b

Country Document Number Publication Date
European Patent Office0260811Mar 23, 1988
Denmark175052May 10, 2004
Luxembourg88684Apr 29, 1996
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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