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TRINTELLIX Drug Profile
» See Plans and Pricing
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 ten 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.
US ANDA Litigation and Generic Entry Outlook for Trintellix
Trintellix was eligible for patent challenges on September 30, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 30, 2031. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $526mm 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.
Indicators of Generic Entry
Summary for TRINTELLIX
| International Patents: | 210 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 137 |
| Clinical Trials: | 8 |
| Patent Applications: | 76 |
| 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 |
| DailyMed Link: | TRINTELLIX at DailyMed |
See drug prices for TRINTELLIX
Generic Entry Opportunity Date for TRINTELLIX
Generic Entry Date for TRINTELLIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TRINTELLIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Noam Soreni | Phase 3 |
| University of Catania | Phase 4 |
| Azienda Ospedaliera Universitaria Integrata Verona | Phase 4 |
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
| 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 | 204447-004 | 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 | ||||
| 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 TRINTELLIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 2431039 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2008113359 | Start Trial |
| Eurasian Patent Organization | 027783 | Start Trial |
| Hong Kong | 1072600 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRINTELLIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1436271 | 1490023-7 | Sweden | Start Trial | PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218 |
| 1436271 | 2014/022 | Ireland | Start Trial | PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220 |
| 1436271 | C20140012 00108 | Estonia | Start Trial | PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013 |
| 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 |
