NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
5/8 — Partial
Priority Review
DEPO-PROVERA (medroxyprogesterone acetate) by Pfizer is suspension, usp inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. First approved in 1992.
Drug data last refreshed 14h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPO-PROVERA (medroxyprogesterone acetate) is an injectable progestin suspension used as a long-acting reversible contraceptive. It works by inhibiting gonadotropin secretion to prevent ovulation and thickens cervical mucus, providing contraceptive efficacy for approximately 12 weeks per injection. The product is a well-established small-molecule hormonal contraceptive with decades of clinical use.
$0.010BPart D
LOE ApproachingModest Part D spending signals a mature, stable product with limited growth potential; commercial teams likely focus on defending market share against newer long-acting reversible contraceptives.
Mechanism of Action
Suspension, USP inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
Started Dec 2020
60 enrolled
Contraception
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
Started Mar 2017
24 enrolled
Contraception
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
Started Oct 2016
12 enrolled
PregnancyContraception
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Started Jul 2010
200 enrolled
HIV
Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
Started May 2010
50 enrolled
Fertility
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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.