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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
Formulation / Manufacturing:see details

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 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>
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,965,156<disabled>Y<disabled>
Bristol Myers Squibb
FUNGIZONE
amphotericin b
SUSPENSION;ORAL050341-003Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Alkopharma Usa
AMPHOTEC
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-002Nov 22, 1996RXYes<disabled><disabled>
Apothecon
FUNGIZONE
amphotericin b
CREAM;TOPICAL050314-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: amphotericin b

Country Document Number Publication Date
Denmark98289Sep 04, 1989
South Korea950013747Nov 15, 1995
Greece3015916Jul 31, 1995
Canada1339008Mar 25, 1997
Norway178484Jan 02, 1996
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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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