Vortioxetine hydrobromide - Generic Drug Details
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What are the generic sources for vortioxetine hydrobromide and what is the scope of patent protection?
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 is one tentative approval 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 |
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
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 | ⤷ 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 | 204447-004 | Sep 30, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | 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 |
---|---|---|---|
Australia | 2002333220 | ⤷ Try a Trial | |
Japan | 3955614 | ⤷ Try a Trial | |
Brazil | PI0713425 | composto, composição farmacêutica, método para tratar uma doença, uso de um composto, e processos para a preparação de um composto, e para a fabricação de um composto | ⤷ Try a Trial |
Israel | 200956 | 1-[2-(2,4-דימתילפנילסולפניל)-פניל]פיפרזין לטיפול בכאב (1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine for use in the treatment of pain) | ⤷ Try a Trial |
Ukraine | 97392 | 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИН КАК СОЕДИНЕНИЕ С КОМБИНИРОВАННОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ОБРАТНОГО ЗАХВАТА СЕРОТОНИНА, 5-НТ3 И 5-НТ1A ДЛЯ ЛЕЧЕНИЯ БОЛИ;1-[2-(2,4-ДИМЕТИЛФЕНІЛСУЛЬФАНІЛ)ФЕНІЛ]ПІПЕРАЗИН ЯК СПОЛУКА З КОМБІНОВАНОЮ АКТИВНІСТЮ СТОСОВНО ЗВОРОТНОГО ЗАХОПЛЕННЯ СЕРОТОНІНУ, 5-HT3 ТА 5-HT1A ДЛЯ ЛІКУВАННЯ БОЛЮ (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) | ⤷ 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 | 122014000049 | Germany | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; 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 |
1436271 | 508 | Finland | ⤷ Try a Trial | |
1436271 | 300652 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |