TRINTELLIX Drug Patent Profile
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Which patents cover Trintellix, and when can generic versions of Trintellix launch?
Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifteen patent family members in forty-one countries.
The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.
DrugPatentWatch® Generic Entry Outlook for Trintellix
Trintellix was eligible for patent challenges on September 30, 2017.
Annual sales in 2019 were $545mm indicating the motivation for generic entry.
There have been twenty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (vortioxetine hydrobromide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TRINTELLIX
International Patents: | 215 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 11 |
Patent Applications: | 114 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TRINTELLIX |
Drug Sales Revenues: | Drug sales revenues for TRINTELLIX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRINTELLIX |
What excipients (inactive ingredients) are in TRINTELLIX? | TRINTELLIX excipients list |
DailyMed Link: | TRINTELLIX at DailyMed |


See drug prices for TRINTELLIX

Recent Clinical Trials for TRINTELLIX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seasons Biotechnology (Taizhou) Co., Ltd. | Phase 1 |
H. Lundbeck A/S | Phase 3 |
Todd Doyle | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for TRINTELLIX
Paragraph IV (Patent) Challenges for TRINTELLIX
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 TRINTELLIX
TRINTELLIX is protected by ten US patents and two FDA Regulatory Exclusivities.
Patents protecting TRINTELLIX
Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
FDA Regulatory Exclusivity protecting TRINTELLIX
INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
Exclusivity Expiration: See Plans and Pricing
ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: See Plans and Pricing
Expired US Patents for TRINTELLIX
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 TRINTELLIX
When does loss-of-exclusivity occur for TRINTELLIX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1481
Estimated Expiration: See Plans and Pricing
Patent: 5797
Estimated Expiration: See Plans and Pricing
Australia
Patent: 07260355
Estimated Expiration: See Plans and Pricing
Patent: 08228638
Estimated Expiration: See Plans and Pricing
Austria
Patent: 5745
Estimated Expiration: See Plans and Pricing
Patent: 0941
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0713425
Estimated Expiration: See Plans and Pricing
Patent: 0808941
Estimated Expiration: See Plans and Pricing
Patent: 2020011899
Estimated Expiration: See Plans and Pricing
Canada
Patent: 55212
Estimated Expiration: See Plans and Pricing
Patent: 84571
Estimated Expiration: See Plans and Pricing
Chile
Patent: 08000795
Estimated Expiration: See Plans and Pricing
Patent: 11001610
Estimated Expiration: See Plans and Pricing
China
Patent: 1472906
Estimated Expiration: See Plans and Pricing
Patent: 1636161
Estimated Expiration: See Plans and Pricing
Patent: 2614179
Estimated Expiration: See Plans and Pricing
Patent: 2617513
Estimated Expiration: See Plans and Pricing
Patent: 3948597
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 20962
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0110058
Estimated Expiration: See Plans and Pricing
Patent: 0120173
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 11183
Estimated Expiration: See Plans and Pricing
Patent: 12635
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 44043
Estimated Expiration: See Plans and Pricing
Patent: 42193
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 5287
Estimated Expiration: See Plans and Pricing
Patent: 7058
Estimated Expiration: See Plans and Pricing
Patent: 0970018
Estimated Expiration: See Plans and Pricing
Patent: 0970870
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 44043
Estimated Expiration: See Plans and Pricing
Patent: 42193
Estimated Expiration: See Plans and Pricing
Patent: 39201
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2008004643
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 34483
Estimated Expiration: See Plans and Pricing
Patent: 71951
Estimated Expiration: See Plans and Pricing
Patent: 72014
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5511
Estimated Expiration: See Plans and Pricing
Patent: 0956
Estimated Expiration: See Plans and Pricing
Patent: 8068
Estimated Expiration: See Plans and Pricing
Japan
Patent: 90013
Estimated Expiration: See Plans and Pricing
Patent: 71790
Estimated Expiration: See Plans and Pricing
Patent: 02929
Estimated Expiration: See Plans and Pricing
Patent: 63609
Estimated Expiration: See Plans and Pricing
Patent: 01742
Estimated Expiration: See Plans and Pricing
Patent: 24082
Estimated Expiration: See Plans and Pricing
Patent: 09541216
Estimated Expiration: See Plans and Pricing
Patent: 10090165
Estimated Expiration: See Plans and Pricing
Patent: 10521501
Estimated Expiration: See Plans and Pricing
Patent: 13056933
Estimated Expiration: See Plans and Pricing
Patent: 15157872
Estimated Expiration: See Plans and Pricing
Patent: 17008086
Estimated Expiration: See Plans and Pricing
Patent: 18199689
Estimated Expiration: See Plans and Pricing
Patent: 20152732
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 0448
Estimated Expiration: See Plans and Pricing
Patent: 0647
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 08016141
Estimated Expiration: See Plans and Pricing
Patent: 09009672
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 575
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 2986
Estimated Expiration: See Plans and Pricing
Patent: 9721
Estimated Expiration: See Plans and Pricing
Norway
Patent: 3929
Estimated Expiration: See Plans and Pricing
Patent: 090229
Estimated Expiration: See Plans and Pricing
Poland
Patent: 44043
Estimated Expiration: See Plans and Pricing
Patent: 42193
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 44043
Estimated Expiration: See Plans and Pricing
Patent: 42193
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 560
Estimated Expiration: See Plans and Pricing
Patent: 205
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 44043
Estimated Expiration: See Plans and Pricing
Patent: 42193
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0810017
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1445514
Estimated Expiration: See Plans and Pricing
Patent: 1459168
Estimated Expiration: See Plans and Pricing
Patent: 1627901
Estimated Expiration: See Plans and Pricing
Patent: 090028712
Estimated Expiration: See Plans and Pricing
Patent: 090125251
Estimated Expiration: See Plans and Pricing
Patent: 130079619
Estimated Expiration: See Plans and Pricing
Patent: 130133078
Estimated Expiration: See Plans and Pricing
Spain
Patent: 55434
Estimated Expiration: See Plans and Pricing
Patent: 79200
Estimated Expiration: See Plans and Pricing
Patent: 32102
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 43091
Estimated Expiration: See Plans and Pricing
Patent: 0817340
Estimated Expiration: See Plans and Pricing
Patent: 0848411
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 08460
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 250
Estimated Expiration: See Plans and Pricing
Patent: 392
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TRINTELLIX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 0212733 | COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO COMPOSTO INIBIDOR DA RECAPTAÇÃO DE SEROTONINA, E, USO DO MESMO | See Plans and Pricing |
Argentina | 066460 | COMPUESTOS DERIVADOS DE FENIL-PIPERAZINA, FENIL-PIPERIDINA Y FENIL-TETRAHIDROPIRIDINA COMO INHIBIDORES DE LA REABSORCION DE LA SEROTONINA, UNA COMPOSICION FARMACEUTICA Y UTILIZACION DE LOS MISMOS PARA LA PREPARACION DE MEDICAMENTOS | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2009062517 | See Plans and Pricing | |
Brazil | 122012023120 | composto inibidor da recaptação de serotonina | See Plans and Pricing |
Cyprus | 1112646 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRINTELLIX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1436271 | CR 2014 00030 | Denmark | See Plans and Pricing | PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218 |
1436271 | PA2014013 | Lithuania | See Plans and Pricing | PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
1436271 | C01436271/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |