NDAORALTABLET
Approved
Mar 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
TYBLUME (levonorgestrel and ethinyl estradiol) by Xeltis is clinical pharmacology mode of action combination oral contraceptives act by suppression of gonadotropins. Approved for ovulation suppression. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYBLUME is an oral combination contraceptive containing levonorgestrel and ethinyl estradiol, approved in March 2020. It suppresses ovulation while altering cervical mucus and endometrial conditions to prevent pregnancy, and is also indicated for osteopenia treatment. The drug represents a standard-of-care hormonal contraceptive with dual-indication positioning.
$0.003BPart D
PeakProduct is at peak lifecycle stage with modest Part D utilization (75 claims in 2023), indicating stable but limited scale; teams are focused on market maintenance rather than high-growth expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Mode of Action Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus)…
Indications (1)
Clinical Trials (7)
Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
Started Aug 2014
20 enrolled
Infections, Human Immunodeficiency Virus and Hepatitis
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
Started Jun 2010
14 enrolled
Hepatitis C
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Started Aug 2009
36 enrolled
Healthy
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Started Sep 2005
526 enrolled
Premenstrual SyndromeMenstruation Disturbances
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Started Feb 2003
2,000 enrolled
Contraception
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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.