NDAORAL-28TABLET
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CYCLESSA (desogestrel; ethinyl estradiol) by Aspen Surgical is clinical pharmacology pharmacodynamics combined oral contraceptives act by suppression of gonadotropins. Approved for pregnancy in women. First approved in 2000.
Drug data last refreshed 19h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYCLESSA is an oral contraceptive tablet combining desogestrel (0.15 mg) and ethinyl estradiol (0.03 mg) in a 28-day cycle. It prevents pregnancy through suppression of gonadotropins and ovulation, with additional effects on cervical mucus and endometrial changes. The active metabolite 3-keto-desogestrel provides high progestational activity with minimal androgenicity.
LOE Approaching
CYCLESSA is approaching loss of exclusivity in a mature, genericized oral contraceptive market; brand teams will likely focus on niche positioning or may downsize significantly.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus,…
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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.