NDAORAL-28TABLET
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
PREMPRO (conjugated estrogens and medroxyprogesterone acetate) by Pfizer is estrogen receptor agonists [moa]. First approved in 1995.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREMPRO is an oral combination hormone replacement therapy (HRT) containing conjugated estrogens and medroxyprogesterone acetate. It works by binding to estrogen receptors to relieve vasomotor symptoms (hot flashes, night sweats) and other menopausal symptoms in postmenopausal women. The fixed-dose combination balances estrogen with progestin to reduce endometrial hyperplasia risk associated with estrogen monotherapy.
$0.040BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest current market presence; commercial teams face declining revenue and shrinking headcount.
Mechanism of Action
Estrogen Receptor Agonists
Pharmacologic Class:
Estrogen
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Started Oct 2007
30 enrolled
Postmenopause
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Started May 2007
Postmenopause
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Started Jan 2007
92 enrolled
PostmenopauseHypertensionPre-Hypertension
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
Started Nov 2006
Estrogen Replacement Therapy
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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.