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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 one branded drug marketed by Takeda Pharms Usa and is included in one NDA. 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 four patent family members in forty-one countries.
There are sixteen drug master file entries for vortioxetine hydrobromide. Two suppliers are listed for this compound.
Summary for vortioxetine hydrobromide
| International Patents: | 204 |
| US Patents: | 10 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 51 |
| Patent Applications: | 55 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vortioxetine hydrobromide |
| DailyMed Link: | vortioxetine hydrobromide at DailyMed |
Recent Litigation for vortioxetine hydrobromide
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| H. Lundbeck A/S v. Apicore US LLC | 2018-07-12 |
| H. Lundbeck A/S v. MSN Laboratories Private Limited | 2018-06-07 |
| H. Lundbeck A/S v. Lupin Limited | 2018-05-21 |
Synonyms for vortioxetine hydrobromide
| 1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl)piperazine monohydrobromide |
| 1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine hydrobromide |
| 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine-hbr |
| 1-[2-[(2,4-dimethylphenyl)thio]phenyl]piperazine hydrobromide |
| 1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine hydrobromide |
| 2796AH |
| 4-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine hydrobromide |
| 4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium bromide |
| 960203-27-4 |
| AB0165485 |
| AC-28325 |
| AKOS016340374 |
| BCP09588 |
| Brintellix |
| Brintellix (TN) |
| C18H22N2S.BrH |
| CHEBI:76015 |
| CHEMBL2107387 |
| CS-1472 |
| D10185 |
| EBD3080710 |
| EX-A2348 |
| FT-0696676 |
| HG-0011 |
| HY-15414A |
| KB-81459 |
| Lu AA 21004 hydrobromide |
| Lu AA 21004 hydrobromide;Lu AA21004 hydrobromide |
| Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine hydrobromide |
| Lu AA21004 (HBr) |
| Lu-AA-21004 |
| Lu-AA21004-(HBr) |
| MolPort-023-298-793 |
| Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-, hydrobromide (1:1) |
| s8021 |
| SB16507 |
| SC-95551 |
| SCHEMBL237653 |
| SW219360-1 |
| TKS641KOAY |
| Trintellix |
| UNII-TKS641KOAY |
| VNGRUFUIHGGOOM-UHFFFAOYSA-N |
| Vortioxetine (hydrobromide) |
| Vortioxetine (Lu AA21004) HBr |
| Vortioxetine (Lu AA21004) hydrobromide |
| Vortioxetine HBr |
| Vortioxetine hydrobromide (JAN/USAN) |
| Vortioxetine hydrobromide [USAN] |
| vortioxetine monohydrobromide |
| W-5911 |
Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TRINTELLIX | TABLET;ORAL | vortioxetine hydrobromide | 204447 | 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 | 204447-002 | Sep 30, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-001 | Sep 30, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for vortioxetine hydrobromide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2008228638 | Start Trial |
| Cyprus | 1112635 | Start Trial |
| Iceland | 8806 | Start Trial |
| Slovenia | 2219647 | Start Trial |
| China | 1561336 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for vortioxetine hydrobromide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1436271 | 302 50003-2014 | Slovakia | Start Trial | OWNER(S): H. LUNDBECK A/S, VALBY, DK |
| 1436271 | 1490023-7 | Sweden | Start Trial | PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218 |
| 1436271 | C20140012 00108 | Estonia | Start Trial | PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013 |
| 1436271 | 92397 | Luxembourg | Start Trial | PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE |
| 1436271 | PA2014013 | Lithuania | Start Trial | PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
