Atomoxetine hydrochloride - Generic Drug Details

What are the generic drug sources for atomoxetine hydrochloride and what is the scope of patent protection?

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

There are fifteen drug master file entries for atomoxetine hydrochloride. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for atomoxetine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	180
Patent Applications:	3,185
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in atomoxetine hydrochloride?	atomoxetine hydrochloride excipients list
DailyMed Link:	atomoxetine hydrochloride at DailyMed

Recent Clinical Trials for atomoxetine hydrochloride

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

Sponsor	Phase
Boehringer Ingelheim	N/A
Elkana Kohn	Phase 2
University of Calgary	Phase 4

See all atomoxetine hydrochloride clinical trials

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.

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

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
Zydus Pharms Usa Inc	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079017-006	Sep 17, 2010	AB	RX	No	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002		DISCN	No	No
Dr Reddys	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	090609-003	Feb 23, 2018	AB	RX	No	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	AB	RX	Yes	No
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983-006	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	021411-004	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005