FLUOXETINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for fluoxetine hydrochloride and what is the scope of patent protection?
Fluoxetine hydrochloride
is the generic ingredient in eight branded drugs marketed by Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Eli Lilly And Co, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, Apil, Epic Pharma Llc, and Teva Pharms, and is included in eighty NDAs. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for fluoxetine hydrochloride. Seventy-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FLUOXETINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 8 |
Applicants: | 55 |
NDAs: | 80 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 71 |
Raw Ingredient (Bulk) Api Vendors: | 174 |
Clinical Trials: | 298 |
Patent Applications: | 6,874 |
What excipients (inactive ingredients) are in FLUOXETINE HYDROCHLORIDE? | FLUOXETINE HYDROCHLORIDE excipients list |
DailyMed Link: | FLUOXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Berry Consultants | Phase 2 |
U.S. Army Medical Research and Development Command | Phase 2 |
Citeline | Phase 2 |
Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 10MG BASE | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 40MG BASE | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE | 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 FLUOXETINE HYDROCHLORIDE
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUOXETINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for FLUOXETINE HYDROCHLORIDE
US Patents and Regulatory Information for FLUOXETINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Operations | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 209419-001 | Nov 16, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 212683-001 | Sep 13, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Slate Run Pharma | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 211444-001 | Sep 13, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lupin Ltd | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 211632-001 | Feb 8, 2019 | 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 FLUOXETINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | PROZAC | fluoxetine hydrochloride | TABLET;ORAL | 020974-002 | Mar 9, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | PROZAC | fluoxetine hydrochloride | TABLET;ORAL | 020974-001 | Mar 9, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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