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Last Updated: October 20, 2020

DrugPatentWatch Database Preview

Vortioxetine hydrobromide - Generic Drug Details

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What are the generic sources for vortioxetine hydrobromide and what is the scope of freedom to operate?

Vortioxetine hydrobromide is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has two hundred and nine patent family members in forty-one countries.

There are sixteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
TRINTELLIX TABLET;ORAL vortioxetine hydrobromide 204447 2017-10-02

US Patents and Regulatory Information for vortioxetine hydrobromide

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 204447-001 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 PA2014013 Lithuania   Start Trial PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 C300652 Netherlands   Start Trial PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271 132014902248131 Italy   Start Trial PRODUCT NAME: VORTIOXETINA O UN SUO SALE DI ADDIZIONE CON UN ACIDO FARMACEUTICAMENTE ACCETTABILE(BRINTELLIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/891/001-2-3-4-5-6-7, 20131218
1436271 14C0033 France   Start Trial PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 302 50003-2014 Slovakia   Start Trial OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271 C20140012 00108 Estonia   Start Trial PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271 300652 Netherlands   Start Trial PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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