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Serving leading biopharmaceutical companies globally:

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Accenture
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Generated: November 18, 2017

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Amphotericin b - Generic Drug Details

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What are the generic drug sources for amphotericin b and what is the scope of amphotericin b freedom to operate?

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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphotericin b has sixty-four patent family members in twenty-four countries.

There are fifteen drug master file entries for amphotericin b. Three suppliers are listed for this compound.

Pharmacology for amphotericin b

Medical Subject Heading (MeSH) Categories 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
Apothecon
FUNGIZONE
amphotericin b
OINTMENT;TOPICAL050313-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Abraxis Pharm
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION062728-001Apr 13, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Apothecon
FUNGIZONE
amphotericin b
CREAM;TOPICAL050314-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Alkopharma Usa
AMPHOTEC
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-001Nov 22, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Parenteral
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION064062-001Mar 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Apothecon
FUNGIZONE
amphotericin b
INJECTABLE;INJECTION060517-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYesYes► Subscribe► SubscribeY ► Subscribe
X Gen Pharms
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION063206-001Apr 29, 1992RXNoYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
FUNGIZONE
amphotericin b
SUSPENSION;ORAL050341-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995► Subscribe► Subscribe
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997► Subscribe► Subscribe
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997► Subscribe► Subscribe
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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
4,963,297 Spontaneous vesticulation of multilamellar liposomes► Subscribe
6,770,290 Amphotericin B liposome preparation► Subscribe
5,948,441 Method for size separation of particles► Subscribe
5,616,334 Low toxicity drug-lipid systems► Subscribe
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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
South Korea970007187► Subscribe
Mexico9203805► Subscribe
New Zealand223660► Subscribe
JapanH01160915► Subscribe
Australia1799088► Subscribe
Canada1330199► Subscribe
Australia2416188► Subscribe
Denmark175052► Subscribe
Norway884391► Subscribe
Australia598958► Subscribe
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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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Serving leading biopharmaceutical companies globally:

Healthtrust
Boehringer Ingelheim
Fuji
US Army
Johnson and Johnson
Medtronic
Federal Trade Commission
Accenture
McKesson
Cantor Fitzgerald

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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