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VARENICLINE TARTRATE

FDA-approved approved Small molecule Quality 14/100

VARENICLINE TARTRATE is a drug. It is currently FDA-approved (first approved 2006) for Smoking cessation.

Varenicline tartrate is a marketed smoking cessation drug with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and efficacy for smoking cessation. The primary risk is the potential increase in competition following the 2028 patent expiry.

At a glance

Generic nameVARENICLINE TARTRATE
ModalitySmall molecule
PhaseFDA-approved
First approval2006

Approved indications

Common side effects

Serious adverse events

Drug interactions

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about VARENICLINE TARTRATE

What is VARENICLINE TARTRATE?

VARENICLINE TARTRATE is a Small molecule drug, indicated for Smoking cessation.

What is VARENICLINE TARTRATE used for?

VARENICLINE TARTRATE is indicated for Smoking cessation.

When was VARENICLINE TARTRATE approved?

VARENICLINE TARTRATE was first approved on 2006.

What development phase is VARENICLINE TARTRATE in?

VARENICLINE TARTRATE is FDA-approved (marketed).

What are the side effects of VARENICLINE TARTRATE?

Common side effects of VARENICLINE TARTRATE include Nausea, Abnormal dreams, Constipation, Flatulence, Vomiting, Insomnia. Serious adverse events: Nicotine withdrawal symptoms, Exacerbation of underlying psychiatric illness.

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