NDAORALTABLET
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
UNISOM (doxylamine succinate) by Sanofi. Approved for nausea and vomiting of pregnancy. First approved in 1978.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNISOM (doxylamine succinate) is an oral tablet approved in 1978 for the treatment of nausea and vomiting of pregnancy (NVP). It is a first-generation antihistamine that crosses the placental barrier with a safety profile established over decades of use in pregnant populations.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential downsizing or transition planning for the brand team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Career Relevance
Working on UNISOM offers exposure to a mature, legacy brand with entrenched market position but minimal growth potential. Career progression is likely limited to optimization and cost-containment activities rather than launch or expansion leadership.
Brand Manager
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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.