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, 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.

Summary for amphotericin b

US Patents:	0
Tradenames:	5
Applicants:	11
NDAs:	14
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	170
Patent Applications:	6,746
Drug Prices:	Drug price trends for amphotericin b
What excipients (inactive ingredients) are in amphotericin b?	amphotericin b excipients list
DailyMed Link:	amphotericin b at DailyMed

See drug prices for amphotericin b

Recent Clinical Trials for amphotericin b

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

Sponsor	Phase
Federal University of Health Science of Porto Alegre	Phase 3
Huashan Hospital	Phase 4
Helwan University	N/A

See all amphotericin b clinical trials

Pharmacology for amphotericin b

Drug Class	Lipid-based Polyene Antifungal Polyene Antifungal

Medical Subject Heading (MeSH) Categories for amphotericin b

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

US Patents and Regulatory Information for amphotericin b

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	064062-001	Mar 31, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	AMPHOTERICIN B	amphotericin b	INJECTABLE;INJECTION	062728-001	Apr 13, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	214010-001	Nov 17, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	⤷ Sign Up	⤷ Sign Up
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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