NDAINJECTIONINJECTABLE
Approved
May 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PROGESTERONE (progesterone) by Teva is clinical pharmacology prometrium capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1978.
Drug data last refreshed 19h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Progesterone is an oral micronized soft-gelatin capsule formulation of progesterone, chemically identical to naturally occurring ovarian progesterone. It is indicated for hormone replacement therapy and other progesterone-dependent conditions in postmenopausal women. The drug works by replacing endogenous progesterone to alleviate menopausal symptoms and support hormonal balance.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), requiring defensive strategies and focus on brand loyalty and lifecycle management.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETRIUM 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.