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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, 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.

Summary for atropine sulfate

US Patents:	0
Tradenames:	19
Applicants:	40
NDAs:	46
Drug Master File Entries:	23
Suppliers / Packagers:	9
Bulk Api Vendors:	96
Clinical Trials:	22
Patent Applications:	6,227
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

(+-)-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
Bayshore Pharms Llc	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	210819-001	Nov 13, 2018	AA	RX	No	No
Par Pharm	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	040357-001	May 2, 2000	AA	RX	No	No
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
Roxane	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086057-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fosun Pharma	LONOX	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085311-002	Approved Prior to Jan 1, 1982		DISCN	No	No