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Vortioxetine manufacturer?

See the DrugPatentWatch profile for Vortioxetine

Vortioxetine is manufactured by Lundbeck and Takeda Pharmaceutical Company [1]. It is marketed under the brand name Trintellix in the United States [2].

What is Vortioxetine used for?


Vortioxetine is used to treat major depressive disorder (MDD) in adults [3]. It works by affecting serotonin levels in the brain [4].

When did Vortioxetine get approved?


Vortioxetine received its initial approval in Denmark in 2013. It was later approved by the U.S. Food and Drug Administration (FDA) in October 2013 and by the European Medicines Agency (EMA) in 2014 [5].

What are the side effects of Vortioxetine?


Common side effects of vortioxetine can include nausea, vomiting, diarrhea, constipation, and abnormal dreams. Less common side effects may involve sexual dysfunction [3].

How does Vortioxetine work?


Vortioxetine is classified as a serotonin modulator and stimulator. It influences several serotonin receptors and inhibits the serotonin transporter, which is thought to contribute to its antidepressant effects [4][6].

What is the difference between Trintellix and Brintellix?


Trintellix is the brand name for vortioxetine used in the United States, while Brintellix was the original brand name used in other markets. The name was changed in the U.S. to Trintellix in 2016 to prevent confusion with the blood thinner Brilinta [2].

When does the patent for Vortioxetine expire?


Patent information for vortioxetine is complex and involves multiple patents covering the compound, its synthesis, and its uses. For detailed and up-to-date patent expiry timelines, DrugPatentWatch.com is a valuable resource [7].

Who are Vortioxetine's competitors?


Vortioxetine competes with other antidepressants used to treat major depressive disorder. These include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and other atypical antidepressants [8].

What clinical data supports Vortioxetine's efficacy?


Clinical trials have demonstrated vortioxetine's efficacy in reducing depressive symptoms. Studies have shown improvements in scores on the Hamilton Depression Rating Scale (HAM-D) and other measures of depression [9].

What are patient concerns regarding Vortioxetine?


Patients often inquire about the effectiveness of vortioxetine for their specific symptoms, potential side effects, and how it compares to other antidepressants they may have tried. Managing nausea and sexual side effects are also common concerns [3].

Sources:
[1] https://www.drugpatentwatch.com/drug/vortioxetine
[2] https://www.drugpatentwatch.com/brand/trintellix
[3] https://www.drugpatentwatch.com/drug/vortioxetine/uses
[4] https://www.drugpatentwatch.com/drug/vortioxetine/mechanism-of-action
[5] https://www.drugpatentwatch.com/drug/vortioxetine/approvals
[6] https://www.drugpatentwatch.com/drug/vortioxetine/pharmacology
[7] https://www.drugpatentwatch.com/drug/vortioxetine/patents
[8] https://www.drugpatentwatch.com/drug/vortioxetine/competitors
[9] https://www.drugpatentwatch.com/drug/vortioxetine/clinical-trials



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AI-Drug Label Prescribing Information Alignment Report

100
100%
Grade A

Excellent

Mostly Aligned

Patient Risk: Low

Summary

The evaluated claim that TRINTELLIX increases the risk of suicidal thoughts/behaviors in patients aged 24 years and younger (including pediatric patients) and that clinicians should monitor closely—especially early in treatment and during dosage changes—is directly supported by the FDA label sections provided (5.1 and 8.4).


Category Scores

Warnings
100
Excellent
Warnings
100
Excellent

Accurate Statements

TRINTELLIX (vortioxetine) increases the risk of suicidal thoughts and behaviors in adolescents and young adults (and pediatric patients), and clinicians should monitor for emergence/worsening, especially early in treatment or during dosage changes.
Supported by Boxed Warning/Section 5.1: increased incidence in antidepressant-treated patients age 24 years and younger; instructions to monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts/behaviors, especially during the initial few months and at times of dosage changes; and guidance to consider changing the regimen (including possibly discontinuing) for persistent worsening or emergent suicidal thoughts/behaviors. Pediatric applicability supported by Section 8.4 reiteration that pediatric safety/effectiveness are not established and that antidepressants such as TRINTELLIX increase risk of suicidal thoughts/behaviors in pediatric patients.

Unsupported Statements


Contradictions


Important Omissions


Safety Assessment

Potential Patient Risk: Low
The claim accurately reflects a boxed warning and associated monitoring language from the provided FDA label; it does not add unsupported risk or omit required safety emphasis relevant to the claim.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue

Suggested Improvement

Drug Brand Mention Assessment

Branding Score
55
Visibility
60
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For


Core Claims
  • “Vortioxetine is manufactured by Lundbeck and Takeda Pharmaceutical Company.”
  • “It is marketed under the brand name Trintellix in the United States.”
  • “Vortioxetine is used to treat major depressive disorder (MDD) in adults.”
  • “Vortioxetine received its initial approval in Denmark in 2013.”
  • “Vortioxetine is classified as a serotonin modulator and stimulator.”
Differentiators

Pricing Perception: Not Mentioned