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 two branded drugs marketed by Takeda Pharms Usa and Zydus Pharms, and is included in two NDAs. 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 sixteen patent family members in forty-two countries.
There are fifteen drug master file entries for vortioxetine hydrobromide. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for VORTIOXETINE HYDROBROMIDE
International Patents: | 216 |
US Patents: | 10 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Patent Applications: | 137 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VORTIOXETINE HYDROBROMIDE |
DailyMed Link: | VORTIOXETINE HYDROBROMIDE at DailyMed |
Generic filers with tentative approvals for VORTIOXETINE HYDROBROMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 20MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for VORTIOXETINE HYDROBROMIDE
Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
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 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VORTIOXETINE HYDROBROMIDE
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 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VORTIOXETINE HYDROBROMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2009009672 | COMPUESTO 1-[2-(2,4-DIMETILFENILSULFANIL)-FENIL]PIPERAZINA EN COMBINACION CON SEROTONINA PARA LA ACTIVIDAD DE RECAPTACION, 5-HT3 Y 5-HT1 PARA EL TRATAIENTO DEL DOLOR O LOS SINTOMAS RESIDUALES EN LA DEPRESION RELACIONADOS CON EL SUEÑO Y LA COGNICION. (1- [2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF PAIN OR RESIDUAL SYMPTOMS IN DEPRESSION RELATING TO SLEEP AND COGNITION.) | ⤷ Sign Up |
Norway | 343929 | ⤷ Sign Up | |
South Korea | 101627901 | ⤷ Sign Up | |
Taiwan | 200848411 | Novel therapeutic uses of 1-[2-(2, 4-dimethylphenylsulfanyl)phenyl]-piperazine | ⤷ Sign Up |
Denmark | 2431039 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VORTIOXETINE HYDROBROMIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1436271 | 122014000049 | Germany | ⤷ Sign Up | PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
1436271 | 132014902248131 | Italy | ⤷ Sign Up | 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 | 92397 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE |
1436271 | C 2014 023 | Romania | ⤷ Sign Up | PRODUCT NAME: VORTIOXETINA SAU O SARE DE ADITIE ACIDA A ACESTEIAACCEPTABILA FARMACEUTIC1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/891; DATE OF NATIONAL AUTHORISATION: 20131218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/891; DATE OF FIRST AUTHORISATION IN EEA: 20131218 |
1436271 | C01436271/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |