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Atropine sulfate - Generic Drug Details

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

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, 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, Abbvie, and Wyeth Ayerst, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for atropine sulfate

US Patents:	0
Tradenames:	19
Applicants:	38
NDAs:	44
Drug Master File Entries:	23
Suppliers / Packagers:	7
Bulk Api Vendors:	74
Clinical Trials:	830
Patent Applications:	6,128
Formulation / Manufacturing:	see details
DailyMed Link:	atropine sulfate at DailyMed

Pharmacology for atropine sulfate

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

Synonyms for atropine sulfate

(-)-Tropic Acid Ester with Tropine

()-HYOSCYAMINE; SULFURIC ACID

(+-)-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

(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

(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, 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-Hyoscyamine

1.alpha.H, sulfate (2:1) (salt)

13269-35-7

1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester)

1alphaH,5alphaH-Tropan-3alpha-ol (+-)-tropate (ester), sulfate (2:1) (salt)

2-Phenylhydracrylic acid 3-alpha-tropanyl ester

2C17H23NO3.H2O4S

3-tropoyloxytropane

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

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

Ambotz55-48-1

AN-41671

AN-46690

Anaspaz

Anaspaz (TN)

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 Ansyr Plastic Syringe

Atropine Sulfate S.O.P.

Atropine Sulfate, Atropa belladonna L.

Atropine sulphate

Atropine sulphate (VAN)

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

Atropine, sulfate (2:1)

ATROPINESULFATE

atropinium cation

Atropinium sulfate

atropinium(1+)

Atropinol

Atropinsal

Atropinsulfat [German]

Atropinum

atropinum sulphuricum

Atropiny siarczan [Polish]

Atropisal

Atropisol

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)-, (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]

BIS(()-HYOSCYAMINE); SULFURIC ACID

bmse000649

BRD-A27290375-001-01-8

Buwecon

Buwecon (TN)

C01479

C1504

C17H23NO3

CAS-51-55-8

CCG-221346

CCG-38370

CCRIS 3080

CHEBI:16684

CHEBI:78734

CHEMBL1396281

CHEMBL1607275

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

Cystospaz (TN)

Cytospaz

D00113

D0RD5W

D0RG3O

d1-hyoscyamine

Daturine

Davurtrop

DB00572

dl-Hyoscyamine

DL-Tropanyl 2-hydroxy-1-phenylpropionate

DL-Tropanyl 2-hydroxy-1-phenylpropionate sulfate

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

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

Gastrosed

GP2470

GTPL320

H 9002

HE066116

HE352268

HMS1920E15

HMS2089A16

HMS2091K15

HMS2231G17

HMS3259M13

HMS3260I05

HMS501L20

HSDB 2199

HY-B1205

Hyocyamine

HyoMax (TN)

hyoscyamine

Hyoscyamine (USP)

Hyoscyamine [BAN]

HYOSCYAMINE HCl

Hyoscyamine sulfate

Hyospasmol (TN)

Hyospaz

Hyosyne

I-Tropine

Ichtho-bellol

Isopto Atropine

Isopto-atropine

l-Atropine

l-Hyopscyamine

L-Hyoscamine

L-Hyoscyamine

L-HYOSCYAMINE SULFATE

Levbid

Levbid (TN)

Levsin (TN)

Levsin SL

Levsinex

Levsinex SR

Lio-atropin

LP00042

LS-22223

LS-22224

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

NCGC00093557-01

NCGC00094592-01

NCGC00094592-02

NCGC00094592-03

NCGC00142514-01

NCGC00142514-03

NCGC00159345-02

NCGC00258041-01

NCGC00260727-01

Neo-Diophen

Neoquess

Neoquess (TN)

NP-010662

NSC 26671

NSC-26671

NSC-755889

NSC26671

NSC755889

Nulev

NuLev (TN)

Ocu-Tropine

OIN

Opera_ID_1088

OR021450

Peptard

Pharmakon1600-01500131

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

RTR-031981

Ryuato

SAM002554885

SBB005985

SC-19284

SCHEMBL14973972

SCHEMBL2812

SCHEMBL31133

Scopolia extract

SMR000058248

SPECTRUM1500131

ST057178

Sulfate d'atropine

Sulfate d'atropine [French]

Sulfatropinol

Symax

Symax (TN)

Symax Duotab

Symax SL

Symax SR

Tox21_110816

Tox21_111590

Tox21_200487

Tox21_500042

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)

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
Par Pharm	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	040357-001	May 2, 2000	AA	RX	No	No
Lannett	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085372-001	Approved Prior to Jan 1, 1982	AA	RX	No	No
Alcon Labs Inc	ISOPTO ATROPINE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	208151-001	Dec 1, 2016		DISCN	No	No
Gd Searle Llc	LOMOTIL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	012462-001	Approved Prior to Jan 1, 1982	AA	RX	Yes	Yes

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