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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
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amphotericin b

Clinical Trials for: amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,874,104<disabled>Y<disabled>
Teva Parenteral
amphotericin b
INJECTABLE;INJECTION064062-001Mar 31, 1995DISCNNo<disabled><disabled>
amphotericin b
CREAM;TOPICAL050314-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Alkopharma Usa
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-001Nov 22, 1996RXYes<disabled><disabled>
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,965,156<disabled>Y<disabled>
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International Patent Family for Ingredient: amphotericin b

Country Document Number Publication Date
Greece3003050Feb 17, 1993
JapanH02502460Aug 09, 1990
European Patent Office0394265Jul 31, 1991
Spain2070131Jun 01, 1995
European Patent Office0260811Jul 20, 1988
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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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