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Amphotericin b - Generic Drug Details

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Amphotericin b is the generic ingredient in five branded drugs marketed by X Gen Pharms, Apothecon, Sigma Tau, Abraxis Pharm, Alkopharma Usa, Astellas, Abbott, Bristol Myers Squibb, and Teva Parenteral, 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 eighty-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

Tradenames:5
Patents:3
Applicants:9
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packaging: see list3
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
Alkopharma Usa
AMPHOTEC
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-001Nov 22, 1996DISCNNo<disabled><disabled>
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713<disabled>Y <disabled>
Apothecon
FUNGIZONE
amphotericin b
OINTMENT;TOPICAL050313-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amphotericin b

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 19955,616,334<disabled>
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 19975,874,104<disabled>
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Non-Orange Book Patents for Generic Ingredient: amphotericin b

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,948,441 Method for size separation of particles<disabled in preview>
4,963,297 Spontaneous vesticulation of multilamellar liposomes<disabled in preview>
6,770,290 Amphotericin B liposome preparation<disabled in preview>
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International Patent Family for Ingredient: amphotericin b

Country Document Number Estimated Expiration
New Zealand223660<disabled in preview>
Finland102724<disabled in preview>
Greece3003050<disabled in preview>
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