Atomoxetine hydrochloride - Generic Drug Details

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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, Strides Pharma, 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.

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

Sponsor

Phase

Apnimed

Phase 3

Bronx VA Medical Center

Phase 1

Assiut University

N/A

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

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

2007-05-29

US Patents and Regulatory Information for atomoxetine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	090609-005	Feb 23, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079017-003	Sep 16, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079021-007	Feb 18, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079022-005	May 30, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079022-003	May 30, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079019-007	May 30, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002	⤷ Sign Up	⤷ Sign Up
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-007

Feb 14, 2005

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-001

Nov 26, 2002

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-008

Feb 14, 2005

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-006

Nov 26, 2002

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-004

Nov 26, 2002

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-005

Nov 26, 2002

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Lilly

STRATTERA

atomoxetine hydrochloride

CAPSULE;ORAL

021411-003

Nov 26, 2002

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>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

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US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	185
Patent Applications:	3,062
What excipients (inactive ingredients) are in atomoxetine hydrochloride?	atomoxetine hydrochloride excipients list
DailyMed Link:	atomoxetine hydrochloride at DailyMed

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors

Atomoxetine hydrochloride - Generic Drug Details

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

Summary for atomoxetine hydrochloride

Recent Clinical Trials for atomoxetine hydrochloride

Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE

Pharmacology for atomoxetine hydrochloride

Medical Subject Heading (MeSH) Categories for atomoxetine hydrochloride

Anatomical Therapeutic Chemical (ATC) Classes for atomoxetine hydrochloride

Paragraph IV (Patent) Challenges for ATOMOXETINE HYDROCHLORIDE

US Patents and Regulatory Information for atomoxetine hydrochloride

Expired US Patents for atomoxetine hydrochloride

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