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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 ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and thirteen 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® Litigation and Generic Entry Outlook for Trintellix
A generic version of TRINTELLIX was approved as vortioxetine hydrobromide by ZYDUS PHARMS on September 17th, 2021.
Summary for TRINTELLIX
| International Patents: | 213 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 154 |
| Clinical Trials: | 10 |
| Patent Applications: | 159 |
| 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 |
|---|---|
| H. Lundbeck A/S | Phase 3 |
| Todd Doyle | Phase 4 |
| Noam Soreni | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for TRINTELLIX
Paragraph IV (Patent) Challenges for TRINTELLIX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TRINTELLIX | TABLET;ORAL | vortioxetine hydrobromide | 204447 | 2017-10-02 |
US Patents and Regulatory Information for TRINTELLIX
TRINTELLIX is protected by ten US patents and four FDA Regulatory Exclusivities.
Patents protecting TRINTELLIX
Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
FDA Regulatory Exclusivity protecting TRINTELLIX
ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER
Exclusivity Expiration: ⤷ Try it Free
UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS
Exclusivity Expiration: ⤷ Try it Free
INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
Exclusivity Expiration: ⤷ Try it Free
ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | |
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >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 TRINTELLIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 2014011 | ⤷ Try it Free |
| Portugal | 2431039 | ⤷ Try it Free |
| Israel | 205466 | ⤷ Try it Free |
| Croatia | P20120173 | ⤷ Try it Free |
| Israel | 160655 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRINTELLIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1436271 | 302 50003-2014 | Slovakia | ⤷ Try it Free | OWNER(S): H. LUNDBECK A/S, VALBY, DK |
| 1436271 | 300652 | Netherlands | ⤷ Try it Free | PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
| 1436271 | 2014C/036 | Belgium | ⤷ Try it Free | PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220 |
| 1436271 | C01436271/01 | Switzerland | ⤷ Try it Free | PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016 |
| 1436271 | 2014/022 | Ireland | ⤷ Try it Free | PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
