TRINTELLIX Drug Patent Profile

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

Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifteen patent family members in forty-one countries.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Trintellix

Trintellix was eligible for patent challenges on September 30, 2017.

Annual sales in 2019 were $545mm indicating the motivation for generic entry.

There have been twenty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (vortioxetine hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TRINTELLIX

International Patents:	215
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	11
Patent Applications:	114
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRINTELLIX
Drug Sales Revenues:	Drug sales revenues for TRINTELLIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRINTELLIX
What excipients (inactive ingredients) are in TRINTELLIX?	TRINTELLIX excipients list
DailyMed Link:	TRINTELLIX at DailyMed

See drug prices for TRINTELLIX

See drug sales revenues for TRINTELLIX

Recent Clinical Trials for TRINTELLIX

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

Sponsor	Phase
Seasons Biotechnology (Taizhou) Co., Ltd.	Phase 1
H. Lundbeck A/S	Phase 3
Todd Doyle	Phase 4

See all TRINTELLIX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRINTELLIX

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRINTELLIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRINTELLIX	Tablets	vortioxetine hydrobromide	5 mg, 10 mg, 15 mg and 20 mg	204447	15	2017-10-02

US Patents and Regulatory Information for TRINTELLIX

TRINTELLIX is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting TRINTELLIX

FDA Regulatory Exclusivity protecting TRINTELLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes			Y	Y

Expired US Patents for TRINTELLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013

International Patents for TRINTELLIX

When does loss-of-exclusivity occur for TRINTELLIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRINTELLIX around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	0212733	COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO COMPOSTO INIBIDOR DA RECAPTAÇÃO DE SEROTONINA, E, USO DO MESMO
Argentina	066460	COMPUESTOS DERIVADOS DE FENIL-PIPERAZINA, FENIL-PIPERIDINA Y FENIL-TETRAHIDROPIRIDINA COMO INHIBIDORES DE LA REABSORCION DE LA SEROTONINA, UNA COMPOSICION FARMACEUTICA Y UTILIZACION DE LOS MISMOS PARA LA PREPARACION DE MEDICAMENTOS
World Intellectual Property Organization (WIPO)	2009062517
Brazil	122012023120	composto inibidor da recaptação de serotonina
Cyprus	1112646

Supplementary Protection Certificates for TRINTELLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	CR 2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271	PA2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	C01436271/01	Switzerland		PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271	14C0033	France		PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	C300652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218