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Last Updated: August 2, 2021

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ATOMOXETINE HYDROCHLORIDE Drug Patent Profile


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

Atomoxetine Hydrochloride is a drug marketed by Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd V, Mylan, 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 17th, 2010.

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Drug patent expirations by year for ATOMOXETINE HYDROCHLORIDE
Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE

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SponsorPhase
Vanderbilt University Medical CenterN/A
Brown UniversityPhase 2
ApnimedPhase 2

See all ATOMOXETINE HYDROCHLORIDE clinical trials

Pharmacology for ATOMOXETINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for ATOMOXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ATOMOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
STRATTERA CAPSULE;ORAL atomoxetine hydrochloride 021411 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
Mylan ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079021-006 Feb 18, 2021 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hetero Labs Ltd V ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 202682-004 Mar 11, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Pharms Usa ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079022-007 May 30, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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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Serving leading biopharmaceutical companies globally:

Dow
Merck
Boehringer Ingelheim
Mallinckrodt
Express Scripts
McKesson

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