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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 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 four tentative approvals for this compound.
Summary for atomoxetine hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 16 |
Suppliers / Packagers: | 18 |
Bulk Api Vendors: | 79 |
Clinical Trials: | 158 |
Patent Applications: | 2,247 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in atomoxetine hydrochloride? | atomoxetine hydrochloride excipients list |
DailyMed Link: | atomoxetine hydrochloride at DailyMed |
Recent Clinical Trials for atomoxetine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brown University | Phase 2 |
Apnimed | Phase 2 |
Raphael Heinzer | Phase 2/Phase 3 |
Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 18MG | CAPSULE;ORAL |
Start Trial | Start Trial | 100MG | CAPSULE;ORAL |
Start Trial | Start Trial | 80MG | CAPSULE;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
Drug Class | Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-006 | Nov 26, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Aurobindo Pharma Ltd | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079016-006 | May 30, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Apotex | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983-006 | May 30, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Dr Reddys Labs Ltd | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 090609-002 | Feb 23, 2018 | 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 | 021411-004 | 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 | 021411-007 | Feb 14, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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