NDAORAL-21TABLET
Approved
Mar 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
ALESSE (ethinyl estradiol; levonorgestrel) by Cadence Neuroscience. Approved for pregnancy. First approved in 1997.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALESSE is an oral contraceptive combining ethinyl estradiol and levonorgestrel, indicated for pregnancy prevention. It is a combination hormonal contraceptive that works by suppressing ovulation and altering cervical mucus to prevent fertilization. This 21-day tablet formulation has been a standard-of-care option since 1997.
LOE Approaching
As an aging branded oral contraceptive approaching loss of exclusivity, the brand team is likely consolidating and planning transition to generic support or product line extensions.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (1)
Observational Trial With Leios/Alesse
Started May 2005
Contraceptives, Oral, Combined
Career Relevance
Working on ALESSE offers limited growth opportunity given its approaching loss of exclusivity and mature market position; roles focus on defending market share and managing the transition to a lower-margin generic environment. Career advancement would likely require movement to higher-growth products or assumption of portfolio management responsibilities across multiple contraceptive brands.
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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.