Vilazodone hydrochloride - Generic Drug Details

What are the generic drug sources for vilazodone hydrochloride and what is the scope of patent protection?

Vilazodone hydrochloride is the generic ingredient in two branded drugs marketed by Allergan, Accord Hlthcare, Alembic Pharms, Invagen Pharms, and Teva Pharms Usa, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vilazodone hydrochloride has sixty patent family members in twenty-nine countries.

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

Summary for vilazodone hydrochloride

International Patents:	60
US Patents:	4
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	27
Patent Applications:	212
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
Montana State University
Patient-Centered Outcomes Research Institute
National Alliance on Mental Illness Montana

See all vilazodone hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for vilazodone hydrochloride

Antidepressive Agents

Serotonin 5-HT1 Receptor Agonists

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vilazodone hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	AB	RX	Yes	No					Y
Teva Pharms Usa	VILAZODONE HYDROCHLORIDE	vilazodone hydrochloride	TABLET;ORAL	208212-003	Sep 30, 2019	AB	RX	No	No
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011	AB	RX	Yes	Yes					Y
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	AB	RX	Yes	No					Y
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
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011

International Patents for vilazodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Slovakia	288162
Poland	208708
Ukraine	76758	ПОЛИМОРФНЫЕ ФОРМЫ ГИДРОХЛОРИДА 1-[4-(5-ЦИАНОИНДОЛ-3-ИЛ)БУТИЛ]-4-(2-КАРБАМОИЛБЕНЗОФУРАН-5-ИЛ)-ПИПЕРАЗИНА;ПОЛІМОРФНІ ФОРМИ ГІДРОХЛОРИДУ 1-'4-(5-ЦІАНОІНДОЛ-3-ІЛ)БУТИЛ-4-(2-КАРБАМОЇЛБЕНЗОФУРАН-5-ІЛ)ПІПЕРАЗИНУ (POLYMORPH FORMS OF HYDROCHLORIDE OF 1-[4-(5-CYANOINDOL-3-YL)BUTYL]-4-(2-CARBAMOYL-BENZOFURAN-5-YL)-PIPERAZINE)
Canada	2683040	FORMES POLYMORPHES DE CHLORHYDRATE DE 1-[4-(5-CYANOINDOL-3-YL)BUTYL-4-(2-CARBAMOYLBENZOFURAN-5-YL)PIPERAZINE (POLYMORPHIC FORMS OF 1-[4-(5-CYANOINDOL-3-YL)BUTYL]-4-(2-CARBAMOYLBENZOFURAN-5-YL)PIPERAZINE HYDROCHLORIDE)
Germany	60233133