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Last Updated: August 9, 2020

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AMBISOME Drug Profile

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Which patents cover Ambisome, and what generic alternatives are available?

Ambisome is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in AMBISOME is amphotericin b. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

US ANDA Litigation and Generic Entry Outlook for Ambisome

A generic version of AMBISOME was approved as amphotericin b by XGEN PHARMS on April 29th, 1992.

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Drug patent expirations by year for AMBISOME
Drug Prices for AMBISOME

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Recent Clinical Trials for AMBISOME

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SponsorPhase
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalPhase 1
Poitiers University HospitalPhase 3
Axis Clinicals LimitedPhase 1

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Pharmacology for AMBISOME

US Patents and Regulatory Information for AMBISOME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 RX Yes Yes   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 AMBISOME

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Moodys
Merck
Mallinckrodt
Colorcon

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