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Healthtrust
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Dow
Covington

Generated: July 19, 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, Leadiant Biosci Inc, Alkopharma Usa, Astellas, Abbott, Abraxis Pharm, Teva Parenteral, X Gen Pharms, and Bristol Myers Squibb, and is included in twelve NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphotericin b has forty-six 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 amphotericin b
Pharmacology for amphotericin b
Medical Subject Heading (MeSH) Categories for amphotericin b
Synonyms for amphotericin b
(1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*))-33-((3-Amino-3,6-dideoxy-beta-D-mannopyranosyl)oxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyc
(1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(3-amino-3,6-dideoxy-beta-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriac
(1S,3R,4E,6E,8E,10E,12E,14E,16E,18S,19R,20R,21S,25R,27R,30R,31R,33S,35R,37S,38R)-3-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyl-tetrahydropyran-2-yl]oxy-19,25,27,30,31,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-
(1S,3R,4E,6E,8E,10E,12E,14E,16E,18S,19R,20R,21S,25R,27R,30R,31R,33S,35R,37S,38R)-3-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-19,25,27,30,31,33,35,37-octahydroxy-18,20,21-trimethyl-
(1S,3R,4E,6E,8E,10E,12E,14E,16E,18S,19R,20R,21S,25R,27R,30R,31R,33S,35R,37S,38R)-3-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-19,25,27,30,31,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-dioxabicyclo
1397-89-3
14,39-Dioxabicyclo(33.3.1)nonatriaconta-19,21,23,25,2 7,29,31-heptaene-36-carboxylic acid, 33-((3-amino-3,6-dideoxy-beta-D-mannopyranosyl)oxy)-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-(1R-(1R*,3S*,5R*,6R*,9R*,
1407-52-9
23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,12,14,16-heptaene-38-carboxylic acid
30782-62-8
397A893
5-18-10-00525 (Beilstein Handbook Reference)
54482-28-9
7XU7A7DROE
8055-20-7
AB00513832
AB00513832_02
Abelcet
Abelecet
ABLC
AC1NQXTD
AI3-26528
AKOS024464746
Ambap1397-89-3
Ambisome
AmBisome (TN)
Amfotericina B
Amfotericina B [INN-Spanish]
Amp B
AMPH-B
Ampho-Moronal
Amphocin
Amphomoronal
Amphortericin B
Amphotec
Amphotec (TN)
Amphotericin
Amphotericin B (JP17/USP/INN)
Amphotericin B [USP:INN:JAN]
Amphotericin B and cinnamon oil
Amphotericin B from Streptomyces sp.
Amphotericin B from Streptomyces sp., ~80% (HPLC), powder
Amphotericin B from Streptomyces sp., BioReagent, suitable for cell culture, ~80% (HPLC)
Amphotericin B from Streptomyces sp., Vetec(TM) reagent grade, BioReagent, suitable for cell culture, ~80%
Amphotericin B liposome
Amphotericin B solubilized, powder, gamma-irradiated, BioXtra, suitable for cell culture
Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered, BioReagent, suitable for cell culture
Amphotericin B, Streptomyces nodosus
Amphotericin-B
Amphotericine B
Amphotericine B [INN-French]
Amphotericinum B
Amphotericinum B [INN-Latin]
Amphozone
AN-11155
Anfotericine B
APKFDSVGJQXUKY-INPOYWNPSA-N
Apothecon
BIDD:GT0351
BPBio1_000374
BRN 0078342
BSPBio_000340
C-AmB
C06573
CAS-1397-89-3
CCG-220410
CCRIS 5963
CHEBI:2682
CS-2169
D00203
DB00681
DSSTox_CID_2601
DSSTox_GSID_22601
DSSTox_RID_76653
DTXSID9022601
EINECS 215-742-2
Fungilin
Fungisome
Fungisone
Fungizone
Fungizone (TN)
Halizon
HMS2096A22
HSDB 3008
HSDB 3008 IAB
HY-B0221
IAB
J10140
Liposomal Amphotericin B
LMPK06000002
LS-187721
MFCD00877763
MolPort-006-113-274
Mysteclin-F
NCGC00090808-01
NCGC00260033-01
NKTR-024
NS 718
NSC 527017
Prestwick3_000410
s1636
SCHEMBL17973
SinuNase
Tox21_111027
Tox21_202484
UNII-7XU7A7DROE
ZINC253387843

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
X Gen Pharms AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 063206-001 Apr 29, 1992 RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-002 Nov 22, 1996 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apothecon FUNGIZONE amphotericin b LOTION;TOPICAL 060570-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb FUNGIZONE amphotericin b SUSPENSION;ORAL 050341-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
Leadiant Biosci Inc ABELCET amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050724-001 Nov 20, 1995 ➤ Sign Up ➤ Sign Up
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ➤ Sign Up ➤ Sign Up
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
5,616,334 Low toxicity drug-lipid systems ➤ Sign Up
5,948,441 Method for size separation of particles ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chubb
US Department of Justice
Teva
Farmers Insurance
Covington
Chinese Patent Office
Moodys
Harvard Business School

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.