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
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 | 204447-004 | 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 | 204447-002 | 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 |
|---|---|---|---|
| Iceland | 7164 | ⤷ Try a Trial | |
| Spain | 2379200 | ⤷ Try a Trial | |
| Denmark | 2044043 | ⤷ Try a Trial | |
| Israel | 205466 | שימוש ב- l- [2-(2,4-דימתילפנילסולפניל)-פניל] פיפראזין ומלחים שלו הקבילים מבחינה רוקחית בייצור תרופה (Use of l-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine and pharmaceutically acceptable salts thereof in the preparation of a medicament) | ⤷ Try a Trial |
| Austria | 386730 | ⤷ Try a Trial | |
| Denmark | 1749818 | ⤷ 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 | PA2014013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| 1436271 | C20140012 00108 | Estonia | ⤷ Try a Trial | PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013 |
| 1436271 | C300652 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
| 1436271 | 1490023-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218 |
| 1436271 | PA2014013,C1436271 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| 1436271 | C01436271/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
