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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 atropine freedom to operate?

Atropine is the generic ingredient in twenty-three branded drugs marketed by Meridian Medcl Techn, Abbvie, 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, 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, Usl Pharma, Valeant Pharm Intl, Watson Labs, Vangard, Superpharm, Halsey, Mylan Institutional, Wyeth Ayerst, and Meridian Medcl, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine. One supplier is listed for this compound.

Summary for atropine

US Patents:	0
Tradenames:	23
Applicants:	40
NDAs:	48
Drug Master File Entries:	23
Suppliers / Packagers:	1
Bulk Api Vendors:	41
Clinical Trials:	176
Patent Applications:	6,005
Formulation / Manufacturing:	see details
DailyMed Link:	atropine at DailyMed

Pharmacology for atropine

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for atropine

Adjuvants, Anesthesia

Anti-Arrhythmia Agents

Bronchodilator Agents

Muscarinic Antagonists

Mydriatics

Parasympatholytics

Synonyms for atropine

(-)-Tropic Acid Ester with Tropine

(+-)-atropine

(+-)-hyoscyamine

(+,-)-Tropyl tropate

(+)-Atropine

(+)-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-syn)-3-[(3-hydroxy-2-phenylpropanoyl)oxy]-8-methyl-8-azoniabicyclo[3.2.1]octane

(3-endo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (2S)-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

(S)-(-)-Hyoscyamine

(S)-Atropine

[(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)

1-Hyoscyamine

13269-35-7

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

Anaspaz (TN)

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, 3(S)-endo-Isomer

Atropine, analytical standard

Atropine, European Pharmacopoeia (EP) Reference Standard

Atropine, meets USP testing specifications

atropinium cation

atropinium(1+)

Atropinol

Atropinum

atropinum sulphuricum

Atropt

Atrosulf

b eta-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester

BDBM200229

BDBM50403547

Belladenal

Bellergal-S

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

Buwecon

Buwecon (TN)

C01479

C1504

C17H23NO3

CAS-51-55-8

CCRIS 3080

CHEBI:16684

CHEBI:78734

CHEMBL475124

CHEMBL517712

cid_174174

CPD001906768

CS-4834

Cystospaz (TN)

Cytospaz

D00113

D0RD5W

D0RG3O

d1-hyoscyamine

Daturine

DB00572

dl-Hyoscyamine

DL-Tropanyl 2-hydroxy-1-phenylpropionate

DL-Tropyl tropate

dl-Tropyltropate

Donnagel

Donnamar

Donnamar (TN)

DSSTox_CID_113

DSSTox_GSID_20113

DSSTox_RID_75375

DTXSID4020113

Egacene

Egazil

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

Gastrosed

GP2470

GTPL320

H 9002

HMS2089A16

HMS2231G17

HMS3259M13

HSDB 2199

HY-B1205

Hyocyamine

HyoMax (TN)

hyoscyamine

Hyoscyamine (USP)

Hyoscyamine [BAN]

HYOSCYAMINE HCl

Hyoscyamine sulfate

Hyospasmol (TN)

Hyospaz

Hyosyne

I-Tropine

Isopto Atropine

Isopto-atropine

l-Atropine

l-Hyopscyamine

L-Hyoscamine

L-Hyoscyamine

Levbid

Levbid (TN)

Levsin (TN)

Levsin SL

Levsinex

Levsinex SR

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

Neo-Diophen

Neoquess

Neoquess (TN)

NP-010662

Nulev

NuLev (TN)

Ocu-Tropine

OIN

Opera_ID_1088

Peptard

Protamine & Atropine

R-(+)-Hyoscyamine

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

Scopolia extract

SMR000058248

ST057178

Symax

Symax (TN)

Symax Duotab

Symax SL

Symax SR

Tox21_110816

Tox21_111590

Tox21_200487

TR-000361

tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate

Tropic acid, (-)-, ester with tropine

Tropic acid, 3-alpha-tropanyl ester

Tropic acid, ester with tropine

Tropine (+/-)-tropate

Tropine tropate

Tropine, (-)-tropate

Tropine, (-)-tropate (ester)

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
Inwood Labs	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085509-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fosun Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086173-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbvie	ATROPINE AND DEMEROL	atropine sulfate; meperidine hydrochloride	INJECTABLE;INJECTION	087848-001	Nov 26, 1982		DISCN	No	No
Meridian Medcl Techn	ATROPEN	atropine	INJECTABLE;INJECTION	017106-002	Jun 19, 2003		RX	Yes	Yes

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