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Last Updated: December 9, 2019

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Atropine sulfate - Generic Drug Details

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

Atropine sulfate is the generic ingredient in nineteen branded drugs marketed by Us Army, Akorn, Alcon Labs Inc, Hospira, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, West-ward Pharms Int, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms Inc, Ascot, Bayshore Pharms Llc, Fosun Pharma, Heather, Hikma Pharms, Inwood Labs, Kv Pharm, Lannett, Lederle, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Vangard, Superpharm, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine sulfate. Nine suppliers are listed for this compound.

Recent Clinical Trials for atropine sulfate

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

SponsorPhase
University of Sao Paulo General HospitalN/A
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePhase 4
Shanghai Eye Disease Prevention and Treatment CenterPhase 4

See all atropine sulfate clinical trials

Synonyms for atropine sulfate
(-)-Tropic Acid Ester with Tropine
(+-)-atropine
(+-)-hyoscyamine
(+,-)-Tropyl tropate
(+)-HYOSCYAMINE
(+/-)-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
(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
(8-methyl-8-azabicyclo[3.2.1]octan-3-yl) 3-hydroxy-2-phenyl-propanoate; sulfuric acid
(8-methyl-8-azabicyclo[3.2.1]octan-3-yl) 3-hydroxy-2-phenylpropanoate; sulfuric acid
[(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)
13269-35-7
1445960-43-9
17108-73-5
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
2C17H23NO3.H2O4S
2C17H23NO3.H2SO4
3-tropoyloxytropane
5093AF
51-55-8
55-48-1
5908-99-6
620-61-1
78597-12-3
8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate
8-methyl-8-azabicyclo[3.2.1]oct-3-yl 3-hydroxy-2-phenylpropanoate sulfate(2:1)
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
AC1L1LFL
AC1L29HW
AC1L5AX3
AC1Q3XL2
AC1Q6XFK
ACon1_000046
AI3-14072
AI3-60219
AKOS015955538
AKOS025397239
AKOS026749880
AKOS027326511
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
AN-41671
AN-46690
Anaspaz
AS-35261
Atropair
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 Care
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 Ansyr Plastic Syringe
Atropine sulfate monohydrate
Atropine Sulfate S.O.P.
Atropine Sulfate, Atropa belladonna L.
Atropine sulphate
Atropine sulphate (VAN)
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]
Atropinum
Atropiny siarczan
Atropiny siarczan [Polish]
Atropisal
Atropisol
Atropt
Atrosulf
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
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
DTXSID4020113
EINECS 200-104-8
EINECS 200-235-0
endo-( inverted exclamation markA)-|A-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester
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
I-Tropine
Ichtho-bellol
Isopto Atropine
Isopto-atropine
L-Hyoscyamine
L-HYOSCYAMINE SULFATE
Lio-atropin
LP00042
LS-22223
LS-22224
LS-7203
MEGxp0_001878
MFCD00022622
Minims
Minims Atropine
MLS000069795
MLS001148094
MLS002695888
MolPort-001-742-593
MolPort-006-069-165
Mydriasine
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
Ocu-Tropine
Opera_ID_1088
Pharmakon1600-01500131
Protamine & Atropine
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
RL00080
ropine tropate
RTR-031981
Ryuato
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
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 (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
Abbvie ATROPINE AND DEMEROL atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 087853-001 Nov 26, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Parke Davis DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087131-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085506-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085876-001 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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