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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

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

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

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
Alkopharma Usa
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-001Nov 22, 1996RXYes<disabled><disabled>
Bristol Myers Squibb
amphotericin b
SUSPENSION;ORAL050341-003Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Sigma Tau
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713<disabled>Y <disabled>
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,965,156<disabled>Y <disabled>
amphotericin b
INJECTABLE;INJECTION060517-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: amphotericin b

Country Document Number Publication Date
New Zealand223660Nov 27, 1990
European Patent Office0394265Nov 02, 1994
Hong Kong115393Nov 05, 1993
Norway884391Oct 04, 1988
Canada1330199Jun 14, 1994
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Preferred citation:

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

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