NDAORAL-28TABLET
Approved
Oct 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
OVULEN-28 (ethynodiol diacetate; mestranol) by Pfizer is clinical pharmacology combination oral contraceptives act primarily by suppression of gonadotropins. Approved for pregnancy in women. First approved in 1967.
Drug data last refreshed 1h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OVULEN-28 is a combination oral contraceptive containing ethynodiol diacetate and mestranol, approved by Pfizer in 1967. It prevents pregnancy primarily by suppressing gonadotropins and ovulation, with secondary mechanisms including cervical mucus thickening and endometrial changes. The 28-day formulation includes seven inert tablets for menstrual cycle regulation.
LOE Approaching
Product approaching loss of exclusivity with minimal active commercial investment; teams are likely downsizing or transitioning to generic support.
Mechanism of Action
CLINICAL PHARMACOLOGY Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm…
Indications (1)
Career Relevance
OVULEN-28 offers minimal career growth opportunities given its LOE-approaching status and zero linked job openings. Professionals assigned to this product are typically managing wind-down operations, generic transition planning, or regulatory compliance rather than growth-oriented initiatives.
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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.