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Serving leading biopharmaceutical companies globally:

Baxter
US Army
Chinese Patent Office
Covington
Deloitte
Queensland Health
Daiichi Sankyo
McKesson
Cantor Fitzgerald
Teva

Generated: January 23, 2018

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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 Apothecon, Sigma Tau, Alkopharma Usa, Astellas, Abbott, Abraxis Pharm, Teva Parenteral, X Gen Pharms, and Bristol Myers Squibb, 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

US Patents and Regulatory Information 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
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-002 Nov 22, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sigma Tau ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abbott AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 064141-001 Dec 23, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abraxis Pharm AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 062728-001 Apr 13, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
X Gen Pharms AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 063206-001 Apr 29, 1992 RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Parenteral AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 064062-001 Mar 31, 1995 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apothecon FUNGIZONE amphotericin b CREAM;TOPICAL 050314-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb FUNGIZONE amphotericin b SUSPENSION;ORAL 050341-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apothecon FUNGIZONE amphotericin b INJECTABLE;INJECTION 060517-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 ➤ Subscribe ➤ Subscribe
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ➤ Subscribe ➤ Subscribe
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
5,616,334 Low toxicity drug-lipid systems ➤ Subscribe
5,948,441 Method for size separation of particles ➤ Subscribe
6,770,290 Amphotericin B liposome preparation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for amphotericin b

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Cerilliant
Federal Trade Commission
Medtronic
Moodys
Novartis
US Army
Healthtrust

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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