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 eleven 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 fifteen patent family members in forty-one countries.
There are fifteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for vortioxetine hydrobromide
International Patents: | 215 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Patent Applications: | 196 |
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 |
See Plans and Pricing | See Plans and Pricing | 20MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 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.
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 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-002 | Sep 30, 2013 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vortioxetine hydrobromide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | C1436271 | See Plans and Pricing | |
Cyprus | 1111183 | See Plans and Pricing | |
Japan | 2014193891 | THERAPEUTIC USE OF COMPOUND HAVING ACTIVITY IN COMBINATION OF SERT, 5-HT3, AND 5-HT1A | See Plans and Pricing |
Eurasian Patent Organization | 007537 | АЗОТСОДЕРЖАЩИЕ ГЕТЕРОЦИКЛИЧЕСКИЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩАЯ ИХ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ЛЕЧЕНИЯ (NITROGEN-CONTAINING HETEROCYCLIC DERIVATIVES, PHARMACEUTICAL COMPOSITION CONTAINING THEM, USE THEREOF AND METHOD FOR THE TREATMENT) | See Plans and Pricing |
Israel | 238068 | See Plans and Pricing | |
Japan | 7179035 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vortioxetine hydrobromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1436271 | 508 | Finland | See Plans and Pricing | |
1436271 | 14C0033 | France | See Plans and Pricing | PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
1436271 | C300652 | Netherlands | See Plans and Pricing | PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
1436271 | 302 50003-2014 | Slovakia | See Plans and Pricing | OWNER(S): H. LUNDBECK A/S, VALBY, DK |
1436271 | 92397 | Luxembourg | See Plans and Pricing | PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE |
1436271 | C01436271/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |