ATOMOXETINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Atomoxetine Hydrochloride, and what generic alternatives are available?

Atomoxetine Hydrochloride is a drug marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, Teva Pharms Usa, and Zydus Pharms Usa Inc. and is included in eight NDAs.

The generic ingredient in ATOMOXETINE HYDROCHLORIDE is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atomoxetine Hydrochloride

A generic version of ATOMOXETINE HYDROCHLORIDE was approved as atomoxetine hydrochloride by ZYDUS PHARMS USA INC on September 16^th, 2010.

Summary for ATOMOXETINE HYDROCHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	185
Patent Applications:	1,749
DailyMed Link:	ATOMOXETINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE

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

Sponsor	Phase
Apnimed	Phase 3
Bronx VA Medical Center	Phase 1
Assiut University	N/A

See all ATOMOXETINE HYDROCHLORIDE clinical trials

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

Anatomical Therapeutic Chemical (ATC) Classes for ATOMOXETINE HYDROCHLORIDE

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ATOMOXETINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRATTERA	Capsules	atomoxetine hydrochloride	10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg	021411	10	2007-05-29

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
Strides Pharma	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079021-006	Feb 18, 2021	AB	RX	No	No
Hetero Labs Ltd V	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	202682-004	Mar 11, 2021	AB	RX	No	No
Teva Pharms Usa	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079022-007	May 30, 2017	AB	RX	No	No
Teva Pharms Usa	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079022-003	May 30, 2017	AB	RX	No	No
Zydus Pharms Usa Inc	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079017-007	Apr 5, 2023	AB	RX	No	No
Zydus Pharms Usa Inc	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079017-005	Sep 16, 2010	AB	RX	No	No