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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
Julphar
Accenture
Fish and Richardson
Deloitte
UBS
Farmers Insurance
Chinese Patent Office
Argus Health

Generated: August 23, 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.

Summary for Generic Name: amphotericin b

Tradenames:5
Patents:2
Applicants:9
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packagers: see list3
Bulk Api Vendors: see list57
Clinical Trials: see list134
Patent Applications: see list9,973
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amphotericin b at DailyMed

Pharmacology for Ingredient: amphotericin b

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;INJECTION050740-001Aug 11, 1997RXYesYes► Subscribe► SubscribeY ► Subscribe
Apothecon
FUNGIZONE
amphotericin b
OINTMENT;TOPICAL050313-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Apothecon
FUNGIZONE
amphotericin b
CREAM;TOPICAL050314-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
FUNGIZONE
amphotericin b
SUSPENSION;ORAL050341-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Alkopharma Usa
AMPHOTEC
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050729-002Nov 22, 1996DISCNNoNo► 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
5,948,441 Method for size separation of particles► Subscribe
5,616,334 Low toxicity drug-lipid systems► Subscribe
6,770,290 Amphotericin B liposome preparation► 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
JapanH02502460► Subscribe
European Patent Office0394265► Subscribe
Israel85607► Subscribe
Germany3852037► Subscribe
JapanH03501732► 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 500+ biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Baxter
Merck
Medtronic
Daiichi Sankyo
UBS
Federal Trade Commission
Farmers Insurance
Colorcon

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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