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
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 | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-001 | Sep 30, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | RX | Yes | No | ⤷ 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 |
|---|---|---|---|
| Eurasian Patent Organization | 015287 | 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИН В КАЧЕСТВЕ СОЕДИНЕНИЯ С СОЧЕТАНИЕМ АКТИВНОСТИ В ОТНОШЕНИИ ПОВТОРНОГО ЗАХВАТА СЕРОТОНИНА, 5-НТИ 5-НТДЛЯ ЛЕЧЕНИЯ КОГНИТИВНОГО НАРУШЕНИЯ (1- [2- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HTAND 5-HTACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT) | ⤷ Sign Up |
| Serbia | 55147 | TERAPEUTSKE UPOTREBE JEDINJENJA KOJA IMAJU KOMBINOVANU SERT, 5-HT3 I 5-HT1A AKTIVNOST (THERAPEUTIC USES OF COMPOUNDS HAVING COMBINED SERT, 5-HT3 AND 5-HT1A ACTIVITY) | ⤷ Sign Up |
| Eurasian Patent Organization | 011096 | ЛЕКАРСТВЕННОЕ СРЕДСТВО, СОДЕРЖАЩЕЕ ПРОИЗВОДНЫЕ ФЕНИЛПИПЕРАЗИНА (MEDICAL PREPARATION COMPRISING PHENYLPIPERAZINE DERIVATIVES) | ⤷ Sign Up |
| Japan | 2011503125 | ⤷ 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 | C300652 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
| 1436271 | 508 | Finland | ⤷ Sign Up | |
| 1436271 | 1490023-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 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 |
