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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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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.
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