Fluoxetine hydrochloride - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for fluoxetine hydrochloride and what is the scope of freedom to operate?
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 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: | 70 |
Raw Ingredient (Bulk) Api Vendors: | 174 |
Clinical Trials: | 298 |
Patent Applications: | 7,337 |
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 |
---|---|
Idorsia Pharmaceuticals Ltd. | Phase 2 |
Berry Consultants | Phase 2 |
U.S. Army Medical Research and Development Command | Phase 2 |
Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 40MG BASE | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 10MG 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 211653-002 | Apr 15, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Epic Pharma Llc | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 078901-003 | Nov 16, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Heritage | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 201336-001 | Oct 1, 2012 | AB1 | 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 |
---|---|---|---|---|---|---|---|
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-001 | Dec 29, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly And Co | PROZAC | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-003 | Jun 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.