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Last Updated: December 5, 2019

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Atropine - Generic Drug Details

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What are the generic sources for atropine and what is the scope of freedom to operate?

Atropine is the generic ingredient in twenty-four branded drugs marketed by Meridian Medcl Techn, Abbvie, Rafa Labs Ltd, 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, Wyeth Ayerst, and Meridian Medcl, and is included in fifty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for atropine

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Recent Clinical Trials for atropine

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

SponsorPhase
University Hospital, AkershusN/A
University Eye Hospital, FreiburgPhase 2/Phase 3
Theodor Bilharz Research InstitutePhase 2/Phase 3

See all atropine clinical trials

Synonyms for atropine
(+-)-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
[(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,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester)
1-alpha-H,5-alpha-H-Tropan-3-alpha-ol (+-)-tropate (ester) (8CI)
13269-35-7
1445960-43-9
1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester)
2-Phenylhydracrylic acid 3-alpha-tropanyl ester
3-tropoyloxytropane
51-55-8
5908-99-6
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 tropate
8-Methyl-8-azabicyclo[3.2.1]octan-3-yl 3-hydroxy-2-phenylpropionate
AB00694549_14
AB00694549-11
AB00694549-12
AC1L5AX3
AC1Q3XL2
ACon1_000046
AI3-60219
AKOS015955538
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
Atropair
Atropen
Atropen (TN)
Atropin
Atropin [German]
Atropin-flexiolen
Atropina
Atropina [Italian]
Atropine (USP)
Atropine [BAN]
Atropine [USP:BAN]
Atropine Care
Atropine for peak identification, European Pharmacopoeia (EP) Reference Standard
Atropine sulfate
Atropine Sulfate Ansyr Plastic Syringe
Atropine Sulfate S.O.P.
Atropine, >=95.0% (NT)
Atropine, >=99% (TLC), powder
Atropine, analytical standard
Atropine, European Pharmacopoeia (EP) Reference Standard
Atropine, meets USP testing specifications
Atropinol
Atropinum
Atropt
Atrosulf
b eta-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester
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)- 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)-, 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, alpha-(hydroxymethyl)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester endo-(+-)-
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
CCRIS 3080
CHEBI:16684
CHEBI:78734
CHEMBL475124
CHEMBL517712
cid_174174
CPD001906768
CS-4834
Cytospaz
D00113
DB00572
dl-Hyoscyamine
DL-Tropanyl 2-hydroxy-1-phenylpropionate
DL-Tropyl tropate
dl-Tropyltropate
Donnagel
DSSTox_CID_113
DSSTox_GSID_20113
DSSTox_RID_75375
DTXSID4020113
EINECS 200-104-8
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
Eyesules
FT-0602865
FT-0627165
GP2470
GTPL320
HMS2089A16
HMS2231G17
HMS3259M13
HSDB 2199
HY-B1205
hyoscyamine
Hyoscyamine sulfate
I-Tropine
Isopto Atropine
Isopto-atropine
L-Hyoscyamine
LS-7203
MEGxp0_001878
MFCD00022622
Minims
Minims Atropine
MLS000069795
MLS001148094
MLS002695888
MolPort-001-742-593
Mydriasine
NC00493
NCGC00017333-02
NCGC00017333-03
NCGC00017333-04
NCGC00017333-05
NCGC00017333-06
NCGC00142514-01
NCGC00142514-03
NCGC00159345-02
NCGC00258041-01
NCGC00385525-01
Neo-Diophen
Ocu-Tropine
Opera_ID_1088
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
SAM002554885
SBB005985
SCHEMBL2812
SMR000058248
ST057178
Tox21_110816
Tox21_111590
Tox21_200487
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)
Troyl tropate
Urised

US Patents and Regulatory Information for atropine

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 087847-001 Nov 26, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Lederle DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086950-001 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
Vangard LO-TROL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 088009-001 Mar 25, 1983 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
Medpointe Pharm Hlc COLONAID atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085737-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE atropine sulfate SOLUTION;INTRAVENOUS 021146-005 Aug 17, 2017 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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