NDAVAGINALGEL
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
CRINONE (progesterone) by AbbVie is clinical pharmacology progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. First approved in 1997.
Drug data last refreshed 4h ago · AI intelligence enriched 7h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRINONE is a vaginal gel formulation of progesterone, a naturally occurring steroid hormone essential for endometrial preparation and pregnancy maintenance. It works by transforming the endometrium into a secretory state and promoting conditions necessary for embryo implantation and pregnancy support. The sustained-release formulation provides prolonged absorption with a 25-50 hour absorption half-life, enabling less frequent dosing compared to intramuscular alternatives.
$0.071BPart D
LOE ApproachingAs a mature product approaching loss of exclusivity with modest Part D volume, the brand team is likely focused on lifecycle extension and defending market share against generic entry rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is essential for the development of…
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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.