PROGESTERONE
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
Nov 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROGESTERONE by Eli Lilly and Company is clinical pharmacology progesterone capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1974.
Drug data last refreshed 3h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Progesterone is a micronized oral capsule formulation of progesterone, chemically identical to naturally occurring ovarian progesterone, designed to improve bioavailability through micronization technology. It is indicated for use in hormone replacement therapy (HRT), typically in combination with conjugated estrogens for postmenopausal women with an intact uterus. The drug works by providing exogenous progesterone to replace declining endogenous levels and protect the endometrium against estrogen-induced proliferation.
LOE Approaching
Product approaching loss of exclusivity with limited commercial runway; brand teams should expect resource reallocation and focus on generic transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Progesterone capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration 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.