NDAORAL-21TABLETPriority Review
Approved
Mar 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LO/OVRAL is an oral contraceptive tablet combining ethinyl estradiol and norgestrel, approved in 1975. It prevents pregnancy through hormonal suppression of ovulation and modification of the cervical mucus and endometrium. This product represents a foundational oral contraceptive formulation in the low-dose estrogen class.
LOE Approaching
As a nearly 50-year-old product approaching loss of exclusivity with moderate competitive pressure (30% index), commercial teams are likely small and focused on lifecycle extension rather than growth.
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.
Career Relevance
Working on LO/OVRAL at this stage means involvement in defensive commercial strategy, regulatory maintenance, and generic transition planning rather than growth initiatives. Career progression may be limited by the product's mature lifecycle, but expertise in mature asset management and generic competition strategies is valuable.
Brand ManagerField Sales Representative
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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.