ATOMOXETINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, 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
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 185 |
Patent Applications: | 2,969 |
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 |
---|---|
Apnimed | Phase 3 |
Bronx VA Medical Center | Phase 1 |
Assiut University | N/A |
Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 100MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 80MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079016-004 | May 30, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079022-004 | May 30, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079021-003 | Feb 18, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 079022-005 | May 30, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-004 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-005 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | STRATTERA | atomoxetine hydrochloride | CAPSULE;ORAL | 021411-008 | Feb 14, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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