SYMBYAX Drug Patent Profile

Which patents cover Symbyax, and when can generic versions of Symbyax launch?

Symbyax is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for SYMBYAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	5
Drug Prices:	Drug price information for SYMBYAX
What excipients (inactive ingredients) are in SYMBYAX?	SYMBYAX excipients list
DailyMed Link:	SYMBYAX at DailyMed

See drug prices for SYMBYAX

Recent Clinical Trials for SYMBYAX

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

Sponsor	Phase
Eli Lilly and Company	Phase 3
Eli Lilly and Company	Phase 4
M.D. Anderson Cancer Center	Phase 1

See all SYMBYAX clinical trials

Pharmacology for SYMBYAX

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

Paragraph IV (Patent) Challenges for SYMBYAX

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 SYMBYAX

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	021520-001	Apr 9, 2007	AB	RX	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003	AB	RX	Yes	Yes
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003	AB	RX	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003	AB	RX	Yes	No

Expired US Patents for SYMBYAX

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

International Patents for SYMBYAX

See the table below for patents covering SYMBYAX around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	296263	Farmaceutická kompozice pro lécení bolesti a jejípouzití (Pharmaceutical composition for treating pain and use thereof)
Portugal	97446	PROCESSO PARA A PREPARACAO DE UM DERIVADO DE TIENOBENZODIAZEPINA, UTIL COMO PRODUTO FARMACEUTICO
Japan	2002516282
European Patent Office	0454436	Composés pharmaceutiques. (Pharmaceutical compounds.)

Supplementary Protection Certificates for SYMBYAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	C970015	Netherlands		PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436	SPC/GB96/058	United Kingdom		PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
0454436	CA 2001 00042	Denmark
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927