NDAORAL-20TABLET
Approved
Mar 1966
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
OVULEN (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 1966.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OVULEN is an oral combination contraceptive containing ethynodiol diacetate and mestranol, approved in 1966. It prevents pregnancy primarily by suppressing gonadotropins to inhibit ovulation, while also altering cervical mucus and endometrial conditions. The product is a foundational oral contraceptive from the early era of hormonal birth control.
LOE Approaching
As a legacy product approaching loss of exclusivity with minimal Part D spending data, OVULEN likely supports a small, maintenance-focused commercial team focused on retention rather than growth.
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 presents a high-risk career opportunity due to LOE-approaching lifecycle and minimal job openings (0 linked positions). Roles will focus on defending market share against generics, managing inventory rundown, and potentially supporting transition activities rather than growth 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.