Trintellix is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 21 US drug patents filed from 2013 to 2023. Out of these, 20 drug patents are active and 1 has expired. Trintellix's patents will be open to challenges from 23 February, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 21, 2032. Details of Trintellix's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8722684 | 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 |
Jun, 2031
(6 years from now) | Active |
| US7144884 | Phenyl-piperazine derivatives as serotonin reuptake inhibitors |
Jun, 2026
(1 year, 6 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9278096 (Pediatric) | Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity |
Sep, 2032
(7 years from now) | Active |
| US9278096 | Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity |
Mar, 2032
(7 years from now) | Active |
|
US8722684 (Pediatric) | 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 |
Dec, 2031
(7 years from now) | Active |
|
US11458134 (Pediatric) | 1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment |
Dec, 2027
(3 years from now) | Active |
|
US8969355 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
|
US9227946 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
|
US9125908 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
|
US9125909 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
|
US9125910 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
|
US9861630 (Pediatric) | 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 |
Dec, 2027
(3 years from now) | Active |
| US9125910 | 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 |
Jun, 2027
(2 years from now) | Active |
| US9227946 | 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 |
Jun, 2027
(2 years from now) | Active |
| US8969355 | 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 |
Jun, 2027
(2 years from now) | Active |
| US9861630 | 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 |
Jun, 2027
(2 years from now) | Active |
| US9125908 | 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 |
Jun, 2027
(2 years from now) | Active |
| US9125909 | 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 |
Jun, 2027
(2 years from now) | Active |
| US11458134 | 1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment |
Jun, 2027
(2 years from now) | Active |
|
US7144884 (Pediatric) | Phenyl-piperazine derivatives as serotonin reuptake inhibitors |
Dec, 2026
(2 years from now) | Active |
| US8476279 | Phenyl-piperazine derivatives as serotonin reuptake inhibitors |
Oct, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Trintellix's patents.
Latest Legal Activities on Trintellix's Patents
Given below is the list of recent legal activities going on the following patents of Trintellix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Aug, 2023 | US9278096 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9227946 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9125908 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9125910 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9125909 |
| Post Issue Communication - Certificate of Correction | 10 Nov, 2022 | US11458134 |
| Recordation of Patent Grant Mailed Critical | 04 Oct, 2022 | US11458134 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Oct, 2022 | US11458134 |
| Email Notification Critical | 15 Sep, 2022 | US11458134 |
| Issue Notification Mailed Critical | 14 Sep, 2022 | US11458134 |
FDA has granted several exclusivities to Trintellix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Trintellix, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Trintellix.
Exclusivity Information
Trintellix holds 7 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Trintellix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 30, 2018 |
| M(M-227) | May 02, 2021 |
| M(M-234) | Oct 19, 2021 |
| M(M-267) | Nov 13, 2023 |
| M(M-187) | Jan 22, 2024 |
| M(M-232) | Aug 23, 2026 |
| Pediatric Exclusivity(PED) | Feb 23, 2027 |
Several oppositions have been filed on Trintellix's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Trintellix's generic, the next section provides detailed information on ongoing and past EP oppositions related to Trintellix patents.
Trintellix's Oppositions Filed in EPO
Trintellix has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 21, 2012, by Sandoz Ag. This opposition was filed on patent number EP08850935A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07764495A | Oct, 2012 | Sandoz AG | Patent maintained as amended |
| EP08850935A | Sep, 2012 | SANDOZ AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Trintellix is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Trintellix's family patents as well as insights into ongoing legal events on those patents.
Trintellix's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Trintellix:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
| Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets | Seasons Biotechnology (Taizhou) Co., Ltd. | COMPLETED (Apr, 2023) | PHASE1 |
Generic Launch
Generic Release Date:
Trintellix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 21, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trintellix Generic API suppliers:
Vortioxetine Hydrobromide is the generic name for the brand Trintellix. 1 company has already filed for the generic of Trintellix. Check out the entire list of companies who have already received approval for Trintellix's generic
How can I launch a generic of Trintellix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trintellix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trintellix's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Trintellix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 15 mg and 20 mg | 02 Oct, 2017 | 15 | 17 Sep, 2021 | 30 Jun, 2031 | Deferred |
About Trintellix
Trintellix is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating major depressive disorder in adults. Trintellix uses Vortioxetine Hydrobromide as an active ingredient. Trintellix was launched by Takeda Pharms Usa in 2013.
Approval Date:
Trintellix was approved by FDA for market use on 30 September, 2013.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Trintellix is 30 September, 2013, its NCE-1 date is estimated to be 23 February, 2026.
Active Ingredient:
Trintellix uses Vortioxetine Hydrobromide as the active ingredient. Check out other Drugs and Companies using Vortioxetine Hydrobromide ingredient
Treatment:
Trintellix is used for treating major depressive disorder in adults.
Dosage:
Trintellix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |