You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 18, 2024

Fluoxetine hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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 Pharms, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Natco Pharma Usa, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Eli Lilly And Co, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Apil, Epic Pharma Llc, Par Pharm, and Teva Pharms, and is included in seventy-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for fluoxetine hydrochloride. Sixty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluoxetine hydrochloride

US Patents:	0
Tradenames:	8
Applicants:	59
NDAs:	78
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	294
Patent Applications:	6,921
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
First Affiliated Hospital Xi'an Jiaotong University	N/A
Chen Qian	Early Phase 1
Second Xiangya Hospital of Central South University	Phase 1/Phase 2

See all fluoxetine hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 10MG BASE	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 40MG BASE	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Serotonin Uptake Inhibitors

US Patents and Regulatory Information for fluoxetine hydrochloride

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	202729-001	Aug 27, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	201336-003	Oct 1, 2012	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

Expired US Patents for fluoxetine hydrochloride

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Try a Trial	⤷ Try a Trial
>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.