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Generic Trintellix Availability

Last updated on Jan 11, 2023.

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.

See also: Generic Drug FAQ.

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.

  • Patent 11,458,134

    Patent expiration dates:

    • June 15, 2027
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      Patent use: USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
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      Drug product
  • Phenyl-piperazine derivatives as serotonin reuptake inhibitors
    Patent 7,144,884
    Issued: December 5, 2006
    Inventor(s): Ruhland; Thomas & Smith; Garrick Paul & Bang-Andersen; Benny & Puschl; Ask & Moltzen; Ejner Knud & Andersen; Kim
    Assignee(s): H. Lundbeck A/S

    The invention provides compounds represented by the general formula I wherein the substituents are defined in the application. The compounds are useful in the treatment of an affective disorder, including depression, anxiety disorders including general anxiety disorder and panic disorder and obsessive compulsive disorder

    Patent expiration dates:

    • June 17, 2026
      ✓ 
      Patent use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Phenyl-piperazine derivatives as serotonin reuptake inhibitors
    Patent 8,476,279
    Issued: July 2, 2013
    Assignee(s): H. Lundbeck A/S

    The invention provides compounds represented by the general formula I wherein the substituents are defined in the application. The compounds are useful in the treatment of an affective disorder, including depression, anxiety disorders including general anxiety disorder and panic disorder and obsessive compulsive disorder.

    Patent expiration dates:

    • October 2, 2022
      ✓ 
      Patent use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
      ✓ 
      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 8,722,684
    Issued: May 13, 2014
    Assignee(s): H. Lundbeck A/S

    1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HT3 and 5-HT1A and 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 8,969,355
    Issued: March 3, 2015
    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 9,125,908
    Issued: September 8, 2015
    Assignee(s): H. Lundbeck A/S

    1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HT3 and 5-HT1A and 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-HT3 and 5-HT1A activity for the treatment of cognitive impairment
    Patent 9,125,909
    Issued: September 8, 2015
    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-HT3 and 5-HT1A activity for the treatment of cognitive impairment
    Patent 9,125,910
    Issued: September 8, 2015
    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-HT3 and 5-HT1a activity for the treatment of cognitive impairment
    Patent 9,227,946
    Issued: January 5, 2016
    Assignee(s): H. Lundbeck A/S

    1-[2-(2,4-dimethylphenylsulphanyl)phenyl]piperazine exhibits potent activity on SERT, 5-HT3 and 5-HT1A and 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
  • Therapeutic uses of compounds having combined SERT, 5-HT3 and 5-HT1A activity
    Patent 9,278,096
    Issued: March 8, 2016
    Assignee(s): H. Lundbeck A/S Takeda Pharmaceuticals North America, Inc.

    New pharmaceutical uses of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine and pharmaceutically acceptable salts thereof are provided.

    Patent expiration dates:

    • March 21, 2032
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      Patent 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-HT3 and 5-HT1A activity for the treatment of cognitive impairment
    Patent 9,861,630
    Issued: January 9, 2018
    Assignee(s): H. Lundbeck A/S

    1-[2-(2,4-dimethylphenylsulphanyl)phenyl)]piperazine exhibits potent activity on SERT, 5-HT3 and 5-HT1A and 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

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:

    • November 13, 2023 - INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
    • January 22, 2024 - ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING

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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