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Last Updated: October 24, 2019

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Amikacin sulfate - Generic Drug Details

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What are the generic sources for amikacin sulfate and what is the scope of patent protection?

Amikacin sulfate is the generic ingredient in five branded drugs marketed by Abbott, Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Sagent Pharms, Teva Pharms Usa, West-ward Pharms Int, Apothecon, and Insmed Inc, and is included in twenty-five NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has one hundred and forty-eight patent family members in twenty-eight countries.

There are fifteen drug master file entries for amikacin sulfate. Six suppliers are listed for this compound.

Summary for amikacin sulfate
Recent Clinical Trials for amikacin sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Insmed IncorporatedPhase 2
Insmed IncorporatedPhase 1/Phase 2

See all amikacin sulfate clinical trials

Pharmacology for amikacin sulfate
Medical Subject Heading (MeSH) Categories for amikacin sulfate
Synonyms for amikacin sulfate
(2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-(3-amino-3-deoxy-alpha-D-glucopyranosyloxy)-4-(6-amino-6-deoxy-alpha-D-glucopyranosyloxy)-3-hydroxycyclohexyl]-2-hydroxybutanamide
(2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-(3-amino-3-deoxy-alpha-D-glucopyranosyloxy)-4-(6-amino-6-deoxy-alpha-D-glucopyranosyloxy)-3-hydroxycyclohexyl]-2-hydroxybutanamide disulfate
(2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide
(2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-{[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-4-{[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy}-3-hydroxycyclohexyl]-2-hydroxybutanamide
(2S)-4-amino-N-{(1R,2S,3S,4R,5S)-5-amino-2-[(3-amino-3-deoxy-alpha-D-glucopyranosyl)oxy]-4-[(6-amino-6-deoxy-alpha-D-glucopyranosyl)oxy]-3-hydroxycyclohexyl}-2-hydroxybutanamide
(2S)-4-Amino-N-{(1R,2S,3S,4R,5S)-5-amino-2-[(3-amino-3-deoxy-alpha-D-glucopyranosyl)oxy]-4-[(6-amino-6-deoxy-alpha-D-glucopyranosyl)oxy]-3-hydroxycyclohexyl}-2-hydroxybutanamide sulfate (1:2)
(S)-O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-D-streptamine
1-N-(L-(-)-4-Amino-2-hydroxybutyryl)kanamycin A
1-N-(L(-)-gamma-Amino-alpha-hydroxybutyryl)kanamycin A
1079316-47-4
108914-65-4
110660-81-6
110660-83-8
111319-93-8
37357-52-1
37517-28-5
38859-32-4
39831-55-5
517A285
6462-EP1441224A2
6462-EP2292612A2
6462-EP2295402A2
6462-EP2301544A1
831A555
84319SGC3C
AB00513828
AB00513828_06
AC1L1YE8
AC1L1ZLB
AC1Q5JTM
AKN
AKOS005383276
AKOS025310105
Amicacin
Amiglyde-V
Amikacillin
amikacin
Amikacin (sulfate)
Amikacin (USP/INN)
Amikacin [USAN:BAN:INN]
Amikacin [USP:INN:BAN]
Amikacin Base
Amikacin bis(sulphate)
Amikacin Dihydrate
Amikacin disulfate
Amikacin disulfate salt
Amikacin disulfate salt, potency: 674-786 mug per mg (as amikacin base)
amikacin disulphate
Amikacin for system suitability, European Pharmacopoeia (EP) Reference Standard
Amikacin Inhalation Solution
Amikacin sulfate (JP17/USP)
Amikacin sulfate [USAN:JAN]
Amikacin sulfate [USAN:USP:JAN]
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Amikacin sulfate salt
Amikacin sulfate salt(1:2)
Amikacin sulfate, European Pharmacopoeia (EP) Reference Standard
Amikacin Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material
Amikacin sulfate, United States Pharmacopeia (USP) Reference Standard
Amikacin, Antibiotic for Culture Media Use Only
Amikacin,(S)
Amikacina
Amikacina [INN-Spanish]
amikacine
Amikacine [INN-French]
Amikacinum
Amikacinum [INN-Latin]
Amikafur
Amikan
Amikavet
Amikin
Amikin (Disulfate)
Amikin (TN)
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Amiklin
Amikozit
Amitrex
Amukin
Antibiotic BB-K 8
ANTIBIOTIC BB-K8
Antibiotic BB-K8 sulfate
API0001444
Arikace
AS-13777
AX8113844
BAY 41-6551
BAY41-6551
BAY416651
BB-K 8
BB-K8
Biklin
Biodacyn
BPBio1_000671
Briclin
BSPBio_000609
C06820
C22H43N5O13
C22H43N5O13.2H2O4S
CAS-37517-28-5
CHEBI:2637
CHEBI:2638
Chemacin
CHEMBL177
CS-2712
CS-3493
D-Streptamine, O-3-amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[6-amino-6-deoxy-.alpha.-D-glucopyranosyl-(1->4)]-N1-[(2S)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1->6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1->4))-N(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-, sulfate (1:2)(salt)
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1,4))-N(sup 1)-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1.fwdarw.6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1.fwdarw.4))-N1-((2S)-4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-
D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1.fwdarw.6)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1.fwdarw.4))-N1-((2S)-4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, sulfate (1:2) (salt)
D00865
D02543
DB00479
DSSTox_CID_2586
DSSTox_GSID_22586
DSSTox_RID_76645
DTXSID3022586
EINECS 253-538-5
EINECS 254-648-6
Fabianol
H978
HSDB 3583
HY-B0509A
HY-B0509B
J10297
Kancin-Gap
KB-276732
Likacin
LKCWBDHBTVXHDL-RMDFUYIESA-N
LS-146896
LS-146898
Lukadin
MAT2501
MCULE-6148260173
MFCD11045969
Mikavir
MolPort-000-761-900
MolPort-003-925-527
N1-[(S)-4-Amino-2-hydroxybutyryl]kanamycin A
N6M33094FD
NCGC00093350-02
NCGC00093350-03
NCGC00093350-05
nktr-061
NN-K 8
NSC 177001
NSC177001
O-3-Amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[6-amino-6-deoxy-.alpha.-D-glucopyranosyl-(1->4)]-1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-D-streptamine
O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1->4)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1->6))-N(3)-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine
O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1->4)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1->6))-N(3)-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2)
O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-6))-N(sup 3)-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine
O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-6))-N(sup 3)-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2)
Pierami
Potentox
Prestwick3_000395
s3065
SCHEMBL1649432
SCHEMBL2985
ST24030081
STK039706
Tox21_111201
Tox21_111201_1
UNII-84319SGC3C
UNII-N6M33094FD
W-106531
ZINC8214483

US Patents and Regulatory Information for amikacin sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063283-001 Oct 31, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063313-001 Apr 11, 1994 AP RX No Yes   Start Trial   Start Trial   Start Trial
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063264-001 Nov 30, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062311-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Express Scripts
Merck

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