NDAORALTABLET
Approved
Sep 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
2/8 — Basic
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEASONALE is an oral contraceptive containing levonorgestrel (progestin) and ethinyl estradiol (estrogen) in an extended-cycle formulation designed to reduce menstrual frequency. It prevents ovulation and thickens cervical mucus to provide contraceptive efficacy. The product is indicated for women seeking pregnancy prevention with fewer menstrual periods per year.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting contracting brand team and shift toward lifecycle management and generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Started Oct 2006
567 enrolled
Breakthrough Bleeding
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Started Jul 2005
0Osteopenia
Career Relevance
Working on SEASONALE offers exposure to mature product management and lifecycle strategy in the contraceptive space, with emphasis on competition management and generic transition planning. Career growth is limited by the product's LOE status; opportunities lie in market defense, cost optimization, and transition planning rather than expansion.
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.