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 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Progesterone is an oral micronized soft-gelatin capsule formulation of naturally-occurring progesterone used to treat infertility, support assisted reproductive technology, prevent preterm birth, and manage menopausal symptoms. It works by replacing or supplementing endogenous progesterone levels, with enhanced bioavailability achieved through micronization technology. The drug is indicated for women across reproductive, fertility, and menopausal stages of life.
LOE Approaching
As a mature, off-patent product approaching end-of-life, the brand team is likely focused on maintaining market share and managing competitive erosion rather than growth initiatives.
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.