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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
Drug Prices:see low prices

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
Teva Parenteral
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION064062-001Mar 31, 1995DISCNNo
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713Jun 18, 2019Y
Apothecon
FUNGIZONE
amphotericin b
INJECTABLE;INJECTION060517-001Approved Prior to Jan 1, 1982DISCNNo
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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>
5,043,107 Preparation small unilamellar vesicles including polyene antifungal antibiotics<disabled in preview>
4,963,297 Spontaneous vesticulation of multilamellar liposomes<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: amphotericin b

Country Document Number Estimated Expiration
Japan2877160<disabled in preview>
Norway178484<disabled in preview>
Austria66598<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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