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Last Updated: August 9, 2020

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Amphotericin b - Generic Drug Details

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What are the generic drug sources for amphotericin b and what is the scope of freedom to operate?

Amphotericin b is the generic ingredient in five branded drugs marketed by Apothecon, Leadiant Biosci Inc, Alkopharma Usa, Astellas, Abbott, Abraxis Pharm, Teva Parenteral, Xgen Pharms, and Bristol Myers Squibb, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for amphotericin b

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Recent Clinical Trials for amphotericin b

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SponsorPhase
Institute of Liver and Biliary Sciences, IndiaN/A
Shanghai Public Health Clinical CenterPhase 3
Wenzhou Central HospitalEarly Phase 1

See all amphotericin b clinical trials

Pharmacology for amphotericin b
Medical Subject Heading (MeSH) Categories for amphotericin b

US Patents and Regulatory Information for amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-002 Nov 22, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb FUNGIZONE amphotericin b SUSPENSION;ORAL 050341-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Apothecon FUNGIZONE amphotericin b LOTION;TOPICAL 060570-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995   Start Trial   Start Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997   Start Trial   Start Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997   Start Trial   Start Trial
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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