Wednesday, July 8, 2026

Drug profile · INN

norethindrone acetate

norethindrone acetate (NORETHINDRONE ACETATE) is a progesterone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 5
Pipeline programs 1
News articles 0
Drug details — norethindrone acetate
US status
approved
Class
Route
ORAL
Patents
5
Programs
1
Data quality
0.89

Quick answer

norethindrone acetate (NORETHINDRONE ACETATE) is a progesterone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN norethindrone acetate
Brand NORETHINDRONE ACETATE
Mechanism Progesterone receptor agonist
Target Progesterone receptor
Route ORAL
Formulation TABLET

Mechanism of action

Progesterone receptor agonist

Primary target: Progesterone receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Estradiol/Norethindrone acetate Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. desogestrel Progesterone receptor agonist
  2. medroxyprogesterone acetate Progesterone receptor agonist
  3. megestrol acetate Progesterone receptor agonist
  4. norethindrone Progesterone receptor agonist
  5. progesterone Progesterone receptor agonist
  6. ulipristal acetate Genito-urinary system and sex hormones (G03)
  1. US 11957684

    Treatment of heavy menstrual bleeding associated with uterine fibroids

    Expires Mon Apr 11 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11793812

    Methods of treating endometriosis

    Expires Mon Oct 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11033551

    Methods of treating uterine fibroids

    Expires Mon Jun 10 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 8058280

    Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof

    Expires Mon Nov 10 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 7300935

    Thienopyrimidine compounds and use thereof

    Expires Mon Nov 22 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is norethindrone acetate?

norethindrone acetate (NORETHINDRONE ACETATE) is a progesterone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for norethindrone acetate?

NORETHINDRONE ACETATE is a marketed brand name for norethindrone acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of norethindrone acetate?

norethindrone acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.