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: | 147 |
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 |
⤷ Try a Trial | ⤷ Try a Trial | 20MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 10MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 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.
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 | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | 204447-002 | Sep 30, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-001 | Sep 30, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VORTIOXETINE HYDROBROMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1171951 | 作為用於治療認知損傷的、具有結合的對血清素再吸收、 活性的化合物的 -二甲基苯基硫烷基 -苯基 哌嗪 (1- [2- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT 5-HT3 5-HT1A 1-[2-(24-)-]) | ⤷ Try a Trial |
Serbia | 51560 | 1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZIN KAO JEDINJENJE SA KOMBINOVANOM AKTIVNOŠĆU VEZANOM ZA PONOVNO PREUZIMANJE SEROTONINA I 5-HT3 I 5HT1A AKTIVNOŠĆU, ZA LEČENJE BOLA ILI REZIDUALNIH SIMPTOMA U DEPRESIJI VEZANIH ZA SAN I KOGNICIJU (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) | ⤷ Try a Trial |
South Korea | 20130133078 | 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT | ⤷ Try a Trial |
Chile | 2008000795 | USO DE 1-[2-(2,4-DIMETILFENILSULFANIL)FENIL)PIPERAZINA PARA EL TRATAMIENTO DEL DOLOR O DE LOS SINTOMAS RESIDUALES DE LA DEPRESION; Y DICHO COMPUESTO. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VORTIOXETINE HYDROBROMIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1436271 | 132014902248131 | Italy | ⤷ Try a 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 | 2014C/036 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220 |
1436271 | PA2014013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
1436271 | CR 2014 00030 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |