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Last Updated: March 28, 2024

AMPHOTERICIN B - Generic Drug Details


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What are the generic drug sources for amphotericin b and what is the scope of patent protection?

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

There are thirteen drug master file entries for amphotericin b. Five suppliers are listed for this compound.

Drug Prices for AMPHOTERICIN B

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Recent Clinical Trials for AMPHOTERICIN B

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of Health Science of Porto AlegrePhase 3
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 3
Matinas BioPharma Nanotechnologies, Inc.Phase 3

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
Eugia Pharma AMPHOTERICIN B amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 214010-001 Nov 17, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-001 Nov 22, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 064141-001 Dec 23, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Spil AMPHOTERICIN B amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 212514-001 Dec 14, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ⤷  Try a Trial ⤷  Try a Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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