NDAORALTABLET
Approved
Apr 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
AYGESTIN (norethindrone acetate) by Aurobindo Pharma is clinical pharmacology combination oral contraceptives act by suppression of gonadotropins. Approved for heavy menstrual bleeding, uterine fibroids, endometriosis and 1 more indications. First approved in 1982.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AYGESTIN (norethindrone acetate) is an oral progestin-only tablet approved in 1982 for contraception and treatment of heavy menstrual bleeding, endometriosis, uterine fibroids, and inflammatory conditions including rheumatoid arthritis and lupus. It works by suppressing gonadotropins to inhibit ovulation while altering cervical mucus and endometrium to reduce implantation likelihood. The drug undergoes rapid deacetylation to norethindrone with approximately 64% bioavailability and extensive hepatic metabolism via CYP3A4.
$0.007BPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Part D spending ($7K in 2023), signaling a mature, generic-competitive asset with limited commercial infrastructure expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY 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) and the…
Worked on AYGESTIN at Aurobindo Pharma? Share your interview experience or compensation data (+7 days Pro)
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.