NDAINJECTIONINJECTABLE
Approved
Dec 1956
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PREMARIN (conjugated estrogens) by Pfizer is estrogen receptor agonists [moa]. First approved in 1956.
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREMARIN is a conjugated estrogen injectable approved in 1956 that works as an estrogen receptor agonist. It is used for hormone replacement therapy and other estrogen-deficiency conditions in women. The drug is administered via injection and represents a foundational estrogen therapy in the market.
LOE Approaching
As PREMARIN approaches loss of exclusivity with moderate competitive pressure, commercial teams should anticipate resource reallocation and increased focus on market defense strategies.
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 (20)
Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women
Started Apr 2014
24 enrolled
Healthy
A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
Started Aug 2012
2 enrolled
Healthy
Premarin Versus Toviaz for Treatment of Overactive Bladder
Started Apr 2012
90 enrolled
Overactive Bladder
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
Started Oct 2011
72 enrolled
Primary Ovarian InsufficiencyVaginitisMetrorrhagia+1 more
Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
Started May 2009
185 enrolled
Postmenopause
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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.