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Last Updated: November 26, 2022

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, 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
Recent Clinical Trials for atomoxetine hydrochloride

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SponsorPhase
Boehringer IngelheimN/A
Elkana KohnPhase 2
University of CalgaryPhase 4

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Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing80MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing60MGCAPSULE;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
Zydus Pharms Usa Inc ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017-006 Sep 17, 2010 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-001 Nov 26, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 090609-003 Feb 23, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-004 Nov 26, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 078983-006 May 30, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-004 Nov 26, 2002 See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-005 Nov 26, 2002 See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-008 Feb 14, 2005 See Plans and Pricing See Plans and Pricing
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-007 Feb 14, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Boehringer Ingelheim
Colorcon
Moodys
Harvard Business School

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