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Atomoxetine hydrochloride - Generic Drug Details

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

Atomoxetine hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Teva Pharms Usa, Zydus Pharms Usa Inc, and Lilly, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atomoxetine hydrochloride. Twenty suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for atomoxetine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	16
Suppliers / Packagers:	20
Bulk Api Vendors:	75
Clinical Trials:	150
Patent Applications:	2,177
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atomoxetine hydrochloride
DailyMed Link:	atomoxetine hydrochloride at DailyMed

Pharmacology for atomoxetine hydrochloride

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for atomoxetine hydrochloride

Adrenergic Uptake Inhibitors

Synonyms for atomoxetine hydrochloride

(-)-N-methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride

(-)-N-Methyl-3-phenyl-3-(o-tolyloxy)propylamine hydrochloride

(3R)-N-methyl-3-(2-methylphenoxy)-3-phenyl-propan-1-amine hydrochloride

(3R)-N-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine hydrochloride

(3R)-N-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine;hydrochloride

(R)-(-)-N-methyl-3-(2-methylphenoxy)-3-phenylpropylamine hydrochloride

(R)-(-)-Tomoxetine hydrochloride

(R)-ATOMOXETINE HYDROCHLORIDE

(R)-N-Methyl-?-(2-methylphenoxy)-benzenepropanamine hydrochloride

(R)-N-Methyl-3-(2-methylphenoxy)-3-phenylpropylamine Hydrochloride

(R)-N-METHYL-3-PHENYL-3-(O-TOLYLOXY)PROPAN-1-AMINE HCL

(R)-N-Methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine hydrochloride

(R)-N-Methyl-gamma-(2-methyl-phenoxy)benzenepropanamine hydrochloride

(r)-n-methyl-gamma-(2-methylphenoxy)-benzenepropanamine hydrochloride

(R)-Tomoxetine hydrochloride

(R)-Tomoxetine hydrochloride, solid

248T597

57WVB6I2W0

82248-59-7

83015-26-3 (Parent)

AB0014234

AB25136

AC1L1HTF

AK-72912

AKOS015920150

AM20060733

AN-11139

API0001557

AT-20429

Atomoxetine (hydrochloride)

Atomoxetine for impurity A identification, European Pharmacopoeia (EP) Reference Standard

Atomoxetine HCL

Atomoxetine hydrochloride (JAN/USP)

Atomoxetine hydrochloride [USAN]

Atomoxetine Hydrochloride 1.0 mg/ml in Methanol (as free base)

Atomoxetine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material

Atomoxetine hydrochloride, European Pharmacopoeia (EP) Reference Standard

Atomoxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Atomoxetine hydrochloride, United States Pharmacopeia (USP) Reference Standard

Atomoxetine, HCl

Benzenepropanamine, N-methyl-gamma-(2-methylphenoxy)-, hydrochloride, (-)-

BR-72912

C17H21NO.HCl

CAS-82248-59-7

CCG-100874

CHEBI:331697

CHEMBL1702

CPD000469177

CS-1085

D02574

DSSTox_CID_24266

DSSTox_GSID_44266

DSSTox_RID_80136

DTXSID2044266

F0001-2408

FT-0655350

HY-17385

K464

KS-1223

LS-177676

LUCXVPAZUDVVBT-UNTBIKODSA-N

LY 139603

LY-135252

LY-139602 [(+)-isomer]

LY-139603

LY139603

M-1314

MFCD06410992

MLS001401377

MLS002153176

MolPort-003-983-468

NC00124

NCGC00016056-02

NCGC00025345-02

s3175

SAM001246626

SB17442

SC-17967

SCHEMBL122111

SMR000469177

SR-01000597779

SR-01000597779-1

SR-01000763397

SR-01000763397-3

ST24020766

Strattera

Strattera (TN)

SW197504-3

Tomoxetine HCl

TOMOXETINE HYDROCHLORIDE

tomoxetine hydrochloride, (-)-isomer

Tox21_110292

Tox21_110292_1

UNII-57WVB6I2W0

Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE; ORAL
		80MG	CAPSULE; ORAL
		60MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for atomoxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079019-005	May 30, 2017	AB	RX	No	No
Apotex Inc	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983-006	May 30, 2017	AB	RX	No	No
Teva Pharms Usa	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079022-004	May 30, 2017	AB	RX	No	No

Expired US Patents for atomoxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002