VILAZODONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for vilazodone hydrochloride and what is the scope of freedom to operate?

Vilazodone hydrochloride is the generic ingredient in two branded drugs marketed by Abbvie, Accord Hlthcare, Alembic, Apotex, Invagen Pharms, and Teva Pharms Usa, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for vilazodone hydrochloride. Thirteen suppliers are listed for this compound.

Summary for VILAZODONE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	27
Patent Applications:	177
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VILAZODONE HYDROCHLORIDE
What excipients (inactive ingredients) are in VILAZODONE HYDROCHLORIDE?	VILAZODONE HYDROCHLORIDE excipients list
DailyMed Link:	VILAZODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for VILAZODONE HYDROCHLORIDE

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

Sponsor	Phase
CGStat LLC
University of New Mexico
National Alliance on Mental Illness Westside Los Angeles

See all VILAZODONE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for VILAZODONE HYDROCHLORIDE

Antidepressive Agents

Serotonin 5-HT1 Receptor Agonists

Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for VILAZODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIIBRYD	Tablets	vilazodone hydrochloride	10 mg, 20 mg, and 40 mg	022567	5	2015-01-21

US Patents and Regulatory Information for VILAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208200-002	Apr 7, 2021	AB	RX	No	No
Teva Pharms Usa	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208212-002	Sep 30, 2019	AB	RX	No	No
Apotex	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208228-002	Jul 7, 2023	AB	RX	No	No
Apotex	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208228-003	Jul 7, 2023	AB	RX	No	No
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	AB	RX	Yes	No
Accord Hlthcare	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208209-001	Apr 27, 2021	AB	RX	No	No

Expired US Patents for VILAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011
Abbvie	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011