Fluoxetine hydrochloride; olanzapine - Generic Drug Details

What are the generic sources for fluoxetine hydrochloride; olanzapine and what is the scope of freedom to operate?

Fluoxetine hydrochloride; olanzapine is the generic ingredient in two branded drugs marketed by Endo Operations, Epic Pharma Llc, Teva Pharms, and Lilly, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for fluoxetine hydrochloride; olanzapine

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	4
Clinical Trials:	16
DailyMed Link:	fluoxetine hydrochloride; olanzapine at DailyMed

Recent Clinical Trials for fluoxetine hydrochloride; olanzapine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
First Affiliated Hospital of Chongqing Medical University	Phase 1/Phase 2
Second Xiangya Hospital of Central South University	Phase 1/Phase 2
First Affiliated Hospital of Zhejiang University	Phase 4

See all fluoxetine hydrochloride; olanzapine clinical trials

Pharmacology for fluoxetine hydrochloride; olanzapine

Drug Class	Atypical Antipsychotic Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for fluoxetine hydrochloride; olanzapine

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBYAX	Capsules	fluoxetine hydrochloride; olanzapine	6 mg/25 mg 12 mg/25 mg 6 mg/50 mg 12 mg/50 mg	021520	1	2005-01-10

US Patents and Regulatory Information for fluoxetine hydrochloride; olanzapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epic Pharma Llc	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	078901-004	Nov 16, 2012	AB	RX	No	No
Epic Pharma Llc	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	078901-002	Nov 16, 2012	AB	RX	No	No
Epic Pharma Llc	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	078901-005	Nov 16, 2012	AB	RX	No	No
Epic Pharma Llc	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	078901-003	Nov 16, 2012	AB	RX	No	No
Endo Operations	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077742-002	Nov 2, 2012	AB	RX	No	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003	AB	RX	Yes	Yes
Endo Operations	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077742-003	Nov 2, 2012	AB	RX	No	No

Expired US Patents for fluoxetine hydrochloride; olanzapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-001	Apr 9, 2007
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003