Wednesday, July 8, 2026

Drug profile · INN

modafinil

modafinil (APO-MODAFINIL) is a dopamine transporter inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 8
Pipeline programs 31
News articles 0
Drug details — modafinil
US status
approved
Class
Route
ORAL
Patents
8
Programs
31
Data quality
0.89

Quick answer

modafinil (APO-MODAFINIL) is a dopamine transporter inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN modafinil
Brand APO-MODAFINIL
Mechanism Dopamine transporter inhibitor
Target Sodium-dependent dopamine transporter
Route ORAL
Formulation TABLET

Mechanism of action

Dopamine transporter inhibitor

Primary target: Sodium-dependent dopamine transporter

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Armodafinil Phase 3 · Teva Pharma · Traumatic Brain Injury
  2. Armodafinil Phase 3 · Teva Pharma · Excessive Daytime Sleepiness
  3. Armodafinil Phase 3 · Teva Pharma · Depression
  4. Armodafinil Phase 3 · Teva Pharma · Narcolepsy
  5. Armodafinil 100 to 250 mg/day Phase 3 · Teva Pharma · Excessive Daytime Sleepiness
  6. Armodafinil 150 mg/day Phase 3 · Teva Pharma · Excessive Sleepiness
  7. Armodafinil 150 mg/day Phase 3 · Teva Pharma · Obstructive Sleep Apnea
  8. Armodafinil 250 mg/day Phase 3 · Teva Pharma · Obstructive Sleep Apnea

Related & competitor drugs

  1. amphetamine adipate Dopamine transporter releasing agent
  2. amphetamine aspartate Norepinephrine transporter releasing agent
  3. amphetamine sulfate Norepinephrine transporter releasing agent
  4. armodafinil Dopamine transporter inhibitor
  5. bupropion hydrochloride Dopamine transporter inhibitor
  6. dexmethylphenidate hydrochloride Norepinephrine transporter inhibitor
  1. US 9382200

    Process for the preparation of and crystalline forms of optical enantiomers of modafinil

    Expires Mon Jun 30 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8975442

    Process for the preparation of and crystalline forms of optical enantiomers of modafinil

    Expires Mon Mar 05 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 8729305

    Process for the preparation of and crystalline forms of optical enantiomers of modafinil

    Expires Mon May 15 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 8563014

    Modafinil oral lyophilizate

    Expires Mon Oct 17 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8048222

    Highly pure modafinil

    Expires Mon Oct 27 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 7960586

    Purification of armodafinil

    Expires Mon Jun 09 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 7235691

    Crystalline forms of modafinil

    Expires Mon Jun 21 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 6849120

    Oxidation method for preparing highly pure modafinil, crystalline forms of modafinil, and methods of preparing the crystalline forms

    Expires Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is modafinil?

modafinil (APO-MODAFINIL) is a dopamine transporter inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for modafinil?

APO-MODAFINIL is a marketed brand name for modafinil. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of modafinil?

modafinil 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.