NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
QSYMIA (phentermine and topiramate) by Teva is cytochrome p450 3a4 inducers [moa]. First approved in 2012.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QSYMIA is a fixed-dose combination of phentermine and topiramate extended-release, approved in 2012 for chronic weight management. It acts as a CYP3A4 inducer to suppress appetite and promote weight loss. The drug is indicated for patients with obesity or weight-related comorbidities.
LOE Approaching2.6 years to LOE
Product is 12+ years post-launch and approaching loss of exclusivity in ~2.7 years; brand team focus is likely on maximizing current revenue and planning for generic competition.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Phase IV Study of Qsymia in Obese Patients
Started Sep 2021
232 enrolled
Obesity
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Started Dec 2014
25 enrolled
ObesityMetabolic SurgeryWeight Loss+1 more
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Started Aug 2014
51 enrolled
Obesity
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.