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Last Updated: May 28, 2020

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ATROPINE SULFATE Drug Profile


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When do Atropine Sulfate patents expire, and when can generic versions of Atropine Sulfate launch?

Atropine Sulfate is a drug marketed by Us Army, Akorn, Fresenius Kabi Usa, and Hospira. and is included in four NDAs.

The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Atropine Sulfate

A generic version of ATROPINE SULFATE was approved as atropine sulfate by AKORN on July 18th, 2014.

  Start Trial

Drug patent expirations by year for ATROPINE SULFATE
Recent Clinical Trials for ATROPINE SULFATE

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

SponsorPhase
Biomedical Advanced Research and Development AuthorityPhase 1
Rho, Inc.Phase 1
University of Sao Paulo General HospitalN/A

See all ATROPINE SULFATE clinical trials

Synonyms for ATROPINE SULFATE
(+-)-atropine
(+-)-hyoscyamine
(+,-)-Tropyl tropate
(+/-)-Atropine
(+/-)-Hyoscyamine
(1beta,3alpha,5beta)-3-[(3-Hydroxy-1-oxo-2-phenylpropyl)oxy]-8-methyl-8-azabicyclo[3.2.1]octane
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropanoate
(1R,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
(1S,5R)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
[(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenyl-propanoate
[(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate
[(1S,5R)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl] 3-hydroxy-2-phenyl-propanoate
[(1S,5R)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenyl-propanoate
1-.alpha.-H, sulfate (2:1) salt
1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester)
1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester) (8CI)
1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester), sulfate (2:1) salt
1.alpha.H, sulfate (2:1) (salt)
1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester)
1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester), sulfate (2:1) (salt)
1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester), sulfate (2:1) (salt) (8CI)
2-Phenylhydracrylic acid 3-alpha-tropanyl ester
2472-17-5
2C17H23NO3.H2O4S
2C17H23NO3.H2SO4
3-tropoyloxytropane
5093AF
51-55-8
55-48-1
620-61-1
8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
8-Methyl-8-azabicyclo[3.2.1]oct-3-yl tropate
8-Methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropionate
A 0257
A0550
AB00694549_14
AB00694549-11
AB00694549-12
ACon1_000046
AI3-14072
AI3-60219
AKOS015955538
AKOS025397239
AKOS026749880
alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester
alpha-Hydroxymethylphenylacetic acid (1R,5S)-8-methyl-8-azabicyclo[3.2.1]octane-3-yl ester
Anaspaz
AS-35261
AS-56020
Atropen
Atropen (TN)
Atropette
Atropin
Atropin [German]
Atropin siran
Atropin siran [Czech]
Atropin-flexiolen
Atropina
Atropina [Italian]
ATROPINE
Atropine (sulfate)
Atropine (USP)
Atropine [BAN]
Atropine [USP:BAN]
Atropine for peak identification, European Pharmacopoeia (EP) Reference Standard
Atropine Sulfate (anhydrous)
Atropine sulfate (VAN)
Atropine sulfate anhydrous
Atropine sulfate anhydrous (2:1) salt
Atropine Sulfate, Atropa belladonna L.
Atropine sulphate
Atropine sulphate (VAN)
atropine-sulfate
Atropine, >=95.0% (NT)
Atropine, >=99% (TLC), powder
Atropine, analytical standard
Atropine, European Pharmacopoeia (EP) Reference Standard
Atropine, meets USP testing specifications
Atropine, sulfate (2:1)
Atropinium sulfate
Atropinol
Atropinsal
Atropinsulfat
Atropinsulfat [German]
Atropiny siarczan
Atropiny siarczan [Polish]
Atropisal
Atropisol
Atropt
b eta-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester
BCP13907
BCP15060
BDBM200229
BDBM50403547
Belladenal
Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester
Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1)
Benzeneacetic acid, alpha-(hydroxymethyl)- (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1) (salt)
Benzeneacetic acid, alpha-(hydroxymethyl)- 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester endo-(+-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester
Benzeneacetic acid, alpha-(hydroxymethyl)-, (3-endo)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, sulfate (2:1) (salt)
Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)-, sulfate (2:1) (salt)
Benzeneacetic acid, alpha-(hydroxymethyl)-, 8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+/-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo [3.2.1]oct-3-yl ester, endo-(+/-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo(3,2,1)oct-3-yl ester, endo-(+-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo(3.2.1)oct-3-yl ester, endo-(+-)-
Benzeneacetic acid, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester endo-(+-)-
Benzeneacetic acid, sulfate (2:1) (salt)
beta-Phenyl-gamma-oxypropionsaeure-tropyl-ester
beta-Phenyl-gamma-oxypropionsaeure-tropyl-ester [German]
beta-Phenyl-gamma-oxypropionsaure-tropyl-ester
beta-Phenyl-gamma-oxypropionsaure-tropyl-ester [German]
bmse000649
BRD-A27290375-001-01-8
BRD-A27290375-330-01-1
C01479
C1504
C17H23NO3
CAS-51-55-8
CAS-55-48-1
CCG-221346
CCG-38370
CCRIS 3080
CHEBI:16684
CHEBI:78734
CHEMBL1396281
CHEMBL1607275
CHEMBL3185794
CHEMBL475124
CHEMBL517712
cid_174174
component of Bar-Tropin
component of Enuretrol
component of Isopto Atropine
component of Lomotil
component of Motofen
Corbella
CPD001906768
CS-4834
CTK5A3690
CTK5A9422
Cytospaz
D00113
Davurtrop
DB-054049
DB00572
dl-Hyoscyamine
DL-Tropanyl 2-hydroxy-1-phenylpropionate
DL-Tropanyl 2-hydroxy-1-phenylpropionate sulfate
DL-Tropyl tropate
dl-Tropyltropate
Donnagel
DSSTox_CID_113
DSSTox_CID_29379
DSSTox_GSID_20113
DSSTox_GSID_49419
DSSTox_RID_75375
DSSTox_RID_83494
DTXSID3049419
DTXSID30947656
DTXSID4020113
EINECS 200-104-8
EINECS 200-235-0
endo-(+/-)-alpha-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester
ENDO-ATROPINE SULFATE
EU-0100042
Eyesule
Eyesules
FT-0602865
FT-0627165
FT-0696350
GP2470
GTPL320
HMS1920E15
HMS2089A16
HMS2091K15
HMS2231G17
HMS3259M13
HMS3260I05
HMS501L20
HSDB 2199
HY-B1205
hyoscyamine
Hyoscyamine sulfate
Hyoscyamine sulfate hydrate
Ichtho-bellol
Isopto-atropine
Lio-atropin
LP00042
LS-22223
LS-22224
LS-7203
MEGxp0_001878
MFCD00022622
MLS000069795
MLS001148094
MLS002695888
NC00493
NCGC00017333-02
NCGC00017333-03
NCGC00017333-04
NCGC00017333-05
NCGC00017333-06
NCGC00093557-01
NCGC00094592-01
NCGC00094592-02
NCGC00094592-03
NCGC00142514-01
NCGC00142514-03
NCGC00159345-02
NCGC00258041-01
NCGC00260392-01
NCGC00260727-01
NCGC00385525-01
Neo-Diophen
NSC 26671
NSC-26671
NSC-755889
NSC26671
NSC755889
Opera_ID_1088
Pharmakon1600-01500131
Protamine & Atropine
Q26272
Q27282144
rac-(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
rac-tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate
RKUNBYITZUJHSG-SPUOUPEWSA-N
ropine tropate
RTR-031981
Ryuato
s5493
SAM002554885
SBB005985
SC-19284
SCHEMBL1411666
SCHEMBL14973972
SCHEMBL2812
SCHEMBL31133
SMR000058248
SPECTRUM1500131
SR-01000075162-11
SR-01000075162-5
ST057178
Sulfate d'atropine
Sulfate d'atropine [French]
Sulfatropinol
Sulfuric acid--(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropanoate (1/2)
Sulfuric acid--8-methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropanoate (1/1)
Tox21_110816
Tox21_111590
Tox21_200487
Tox21_202846
Tox21_500042
TR-000361
tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate
Tropic acid, 3-alpha-tropanyl ester
Tropic acid, ester with tropine
Tropine (+/-)-tropate
Tropine tropate
Tropine tropate;DL-Hyoscyamine
Tropine, tropate (ester)
Tropintran
Troyl tropate
Urised
W-105053
WLN: T56 A ANTJ A GOVYR&1Q & 2 &.H2.S-O4.QH

US Patents and Regulatory Information for ATROPINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Army ATROPINE SULFATE atropine sulfate AEROSOL, METERED;INHALATION 020056-001 Sep 19, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE atropine sulfate SOLUTION;INTRAVENOUS 021146-004 Aug 17, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira ATROPINE SULFATE ANSYR PLASTIC SYRINGE atropine sulfate SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL 021146-002 Jul 9, 2001 RX Yes Yes   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:

Mallinckrodt
Harvard Business School
Merck
Boehringer Ingelheim
Colorcon
McKesson

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