Generic Trintellix Availability

Last updated on Sep 11, 2024.

Trintellix is a brand name of vortioxetine, approved by the FDA in the following formulation(s):

TRINTELLIX (vortioxetine hydrobromide - tablet;oral)

Manufacturer: TAKEDA PHARMS USA
Approval date: September 30, 2013
Strength(s): EQ 5MG BASE ^[RLD], EQ 10MG BASE ^[RLD], EQ 15MG BASE (discontinued) ^[RLD], EQ 20MG BASE ^[RLD]

Has a generic version of Trintellix been approved?

No. There is currently no therapeutically equivalent version of Trintellix available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trintellix. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

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
Patent 11,458,134
Issued: October 4, 2022
Inventor(s): Faldt André & Lopez de Diego Heidi & Holm Rene & Mealy Michael J.
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent use: USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
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  Drug product
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
Patent 11458134*PE
Issued: October 4, 2022
Inventor(s): Faldt André & Lopez de Diego Heidi & Holm Rene & Mealy Michael J.
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- December 15, 2027
Patent 7,144,884
Patent expiration dates:
- June 17, 2026
  ✓
  Patent use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
  ✓
  Drug substance
  ✓
  Drug product
Patent 7144884*PED
Patent expiration dates:
- December 17, 2026
  ✓
  Pediatric exclusivity
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 8,722,684
Issued: May 13, 2014
Inventor(s): Bang-Andersen Benny & Faldt Andre & Mork Arne & Lopez de Diego Heidi & Holm Rene & Stensbol Tine Bryan & Moore Nicholas
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- June 30, 2031
  ✓
  Drug substance
  ✓
  Drug product
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 8722684*PED
Issued: May 13, 2014
Inventor(s): Bang-Andersen Benny & Faldt Andre & Mork Arne & Lopez de Diego Heidi & Holm Rene & Stensbol Tine Bryan & Moore Nicholas
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- December 30, 2031
  ✓
  Pediatric exclusivity
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 8,969,355
Issued: March 3, 2015
Inventor(s): Bang-Andersen Benny & Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
This disclosure relates to a method of treating a disease selected from the group consisting of affective disorders, depression, major depressive disorder, anxiety, general anxiety disorder, social anxiety disorder, obsessive compulsive disorder, panic disorder, and panic attacks. The method includes administering a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof to a patient in need thereof, in which Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
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 8969355*PED
Issued: March 3, 2015
Inventor(s): Bang-Andersen Benny & Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
This disclosure relates to a method of treating a disease selected from the group consisting of affective disorders, depression, major depressive disorder, anxiety, general anxiety disorder, social anxiety disorder, obsessive compulsive disorder, panic disorder, and panic attacks. The method includes administering a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof to a patient in need thereof, in which Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9,125,908
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Mork Arne & Stensbol Tine Bryan & Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent 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-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9125908*PED
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Mork Arne & Stensbol Tine Bryan & Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9,125,909
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Faldt Andre & Mork Arne & de Diego Heidi Lopez & Holm Rene & Stensbol Tine Bryan
Assignee(s): H. Lundbeck A/S
This disclosure relates to 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or a pharmaceutically acceptable salt thereof in a crystalline form.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent 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-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9125909*PED
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Faldt Andre & Mork Arne & de Diego Heidi Lopez & Holm Rene & Stensbol Tine Bryan
Assignee(s): H. Lundbeck A/S
This disclosure relates to 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or a pharmaceutically acceptable salt thereof in a crystalline form.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity
1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9,125,910
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Mork Arne & Stensbol Tine Bryan & Faldt Andre
Assignee(s): H. Lundbeck A/S
This disclosure relates to a method of treating a disease selected from the group consisting of Alzheimer's disease, cognitive impairment, and attention deficit hyperactivity disorder (ADHD). The method includes administering a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof to patient in need thereof, in which Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent 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-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9125910*PED
Issued: September 8, 2015
Inventor(s): Bang-Andersen Benny & Mork Arne & Stensbol Tine Bryan & Faldt Andre
Assignee(s): H. Lundbeck A/S
This disclosure relates to a method of treating a disease selected from the group consisting of Alzheimer's disease, cognitive impairment, and attention deficit hyperactivity disorder (ADHD). The method includes administering a therapeutically effective amount of Compound I or a pharmaceutically acceptable salt thereof to patient in need thereof, in which Compound I is 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity
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 9,227,946
Issued: January 5, 2016
Inventor(s): Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
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 9227946*PED
Issued: January 5, 2016
Inventor(s): Faldt Andre & Holm Rene & de Diego Heidi Lopez
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity
Therapeutic uses of compounds having combined SERT, 5-HTand 5-HTactivity
Patent 9,278,096
Issued: March 8, 2016
Inventor(s): Dragheim Marianne
New pharmaceutical uses of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine and pharmaceutically acceptable salts thereof are provided.
Patent expiration dates:
- March 21, 2032
  ✓
  Patent use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT
Therapeutic uses of compounds having combined SERT, 5-HTand 5-HTactivity
Patent 9278096*PED
Issued: March 8, 2016
Inventor(s): Dragheim Marianne
New pharmaceutical uses of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine and pharmaceutically acceptable salts thereof are provided.
Patent expiration dates:
- September 21, 2032
  ✓
  Pediatric exclusivity
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9,861,630
Issued: January 9, 2018
Inventor(s): Faldt André & Lopez de Diego Heidi & Holm Rene
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl)]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- June 15, 2027
  ✓
  Patent use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HTand 5-HTactivity for the treatment of cognitive impairment
Patent 9861630*PED
Issued: January 9, 2018
Inventor(s): Faldt André & Lopez de Diego Heidi & Holm Rene
Assignee(s): H. Lundbeck A/S
1-[2-(2,4-dimethylphenylsulphanyl)phenyl)]piperazine exhibits potent activity on SERT, 5-HTand 5-HTand may as such be useful for the treatment of cognitive impairment, especially in depressed patients.
Patent expiration dates:
- December 15, 2027
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- January 22, 2024 - ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
- August 23, 2026 - INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
- February 23, 2027 - PEDIATRIC EXCLUSIVITY

More about Trintellix (vortioxetine)

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Major Depressive Disorder

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

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