NDAORALTABLET
Approved
Jan 2018
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
7
Data completeness
6/8 — Strong
BALCOLTRA (levonorgestrel and ethinyl estradiol) by Xeltis is ovulation. First approved in 2018.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BALCOLTRA is an oral combined hormonal contraceptive tablet containing levonorgestrel and ethinyl estradiol, approved in 2018 for contraception and osteopenia prevention. It works primarily by suppressing ovulation, with secondary mechanisms including cervical mucus thickening and endometrial changes that reduce pregnancy likelihood. The product represents a dual-indication oral contraceptive addressing both family planning and bone health in women.
$0.039MPart D
LOE Approaching1.1 years to LOEWith loss of exclusivity imminent (June 2027), the brand team faces a critical transition period requiring defensive strategies and a lean organizational structure focused on managed decline.
Mechanism of Action
ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.