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FLUOXETINE HYDROCHLORIDE Drug Profile
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When do Fluoxetine Hydrochloride patents expire, and what generic alternatives are available?
Fluoxetine Hydrochloride is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms Inc, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Celltrion, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Akorn, Aurobindo Pharma Ltd, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Taro, Torrent, and Upsher Smith Labs. and is included in sixty-one NDAs.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluoxetine Hydrochloride
A generic version of FLUOXETINE HYDROCHLORIDE was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2nd, 2001.
Summary for FLUOXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 61 |
| Suppliers / Packagers: | 60 |
| Bulk Api Vendors: | 141 |
| Clinical Trials: | 244 |
| Patent Applications: | 3,937 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Harvard University | N/A |
| Washington State University | N/A |
| Ann & Robert H Lurie Children's Hospital of Chicago | Phase 3 |
Pharmacology for FLUOXETINE HYDROCHLORIDE
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUOXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for FLUOXETINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROZAC | SOLUTION;ORAL | fluoxetine hydrochloride | 020101 | |
| PROZAC | TABLET;ORAL | fluoxetine hydrochloride | 020974 | |
| PROZAC | CAPSULE;ORAL | fluoxetine hydrochloride | 018936 | |
| PROZAC WEEKLY | CAPSULE, DELAYED REL PELLETS;ORAL | fluoxetine hydrochloride | 021235 | |
| SARAFEM | CAPSULE;ORAL | fluoxetine hydrochloride | 018936 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharm Assoc | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 076015-001 | Jan 30, 2002 | AA | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Sciegen Pharms Inc | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 211282-001 | Jan 10, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Marksans Pharma | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 075465-002 | Jan 29, 2002 | AB1 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Heritage Pharms Inc | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 201336-001 | Oct 1, 2012 | DISCN | 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 |
