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Last Updated: March 29, 2024

ATOMOXETINE HYDROCHLORIDE - Generic Drug Details


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

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.

Summary for ATOMOXETINE HYDROCHLORIDE
Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE

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

SponsorPhase
ApnimedPhase 3
Bronx VA Medical CenterPhase 1
Assiut UniversityN/A

See all ATOMOXETINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial80MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial60MGCAPSULE;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
Medical Subject Heading (MeSH) Categories for ATOMOXETINE HYDROCHLORIDE
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
Aurobindo Pharma ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079016-007 May 30, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 202682-005 Mar 11, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 090609-005 Feb 23, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079019-006 May 30, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079016-004 May 30, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa Inc ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017-007 Apr 5, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try a Trial ⤷  Try a Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-006 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-008 Feb 14, 2005 ⤷  Try a Trial ⤷  Try a Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-002 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-005 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-004 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.