ATOMOXETINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Atomoxetine Hydrochloride, and what generic alternatives are available?
Atomoxetine Hydrochloride is a drug marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, Teva Pharms Usa, and Zydus Pharms Usa Inc. and is included in eight NDAs.
The generic ingredient in ATOMOXETINE HYDROCHLORIDE is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atomoxetine Hydrochloride
A generic version of ATOMOXETINE HYDROCHLORIDE was approved as atomoxetine hydrochloride by ZYDUS PHARMS USA INC on September 16th, 2010.
Summary for ATOMOXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 184 |
| Patent Applications: | 1,834 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ATOMOXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Apnimed | Phase 3 |
| Bronx VA Medical Center | Phase 1 |
| Assiut University | N/A |
Pharmacology for ATOMOXETINE HYDROCHLORIDE
| Drug Class | Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for ATOMOXETINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Strides Pharma | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079021-006 | Feb 18, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hetero Labs Ltd V | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 202682-004 | Mar 11, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079022-007 | May 30, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079022-003 | May 30, 2017 | 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 |
