➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
AstraZeneca
Medtronic
Moodys
Express Scripts

Last Updated: April 11, 2021

DrugPatentWatch Database Preview

Atomoxetine hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Teva Pharms Usa, Zydus Pharms Usa Inc, and Lilly, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for atomoxetine hydrochloride. Eighteen 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
Brown UniversityPhase 2
ApnimedPhase 2
ApnimedPhase 2/Phase 3

See all atomoxetine hydrochloride clinical trials

Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGCAPSULE;ORAL
  Start Trial  Start Trial60MGCAPSULE;ORAL
  Start Trial  Start Trial40MGCAPSULE;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 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
Aurobindo Pharma Ltd ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079016-003 May 30, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079022-002 May 30, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079022-006 May 30, 2017 AB RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-005 Nov 26, 2002   Start Trial   Start Trial
Lilly STRATTERA atomoxetine hydrochloride CAPSULE;ORAL 021411-008 Feb 14, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Merck
Boehringer Ingelheim
AstraZeneca
Dow

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.