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Armodafinil | CAS No: 112111-43-0 | GMP-certified suppliers
A medication that supports wakefulness in conditions with excessive sleepiness, including obstructive sleep apnea, narcolepsy, shift work disorder, and explored applications in select neuropsychiatric disorders.
Therapeutic categories
Primary indications
- Investigated for use/treatment in sleep disorders, obstructive sleep apnea, schizophrenia and schizoaffective disorders, depression, and bipolar disorders
Product Snapshot
- Oral small‑molecule product supplied in tablet and coated‑tablet formulations
- Used for sleep‑wake regulation disorders with investigation in psychiatric and mood‑related indications
- Approved in the US with additional investigational programs in other therapeutic areas
Clinical Overview
Armodafinil is categorized as a eugeroic and produces prolonged wake‑promoting effects without acting as a direct or indirect dopamine receptor agonist. Its precise mechanism of action has not been fully established. In vitro data demonstrate binding to the dopamine transporter with inhibition of dopamine reuptake, consistent with modulation of dopaminergic tone. It does not show meaningful binding across multiple receptors commonly involved in sleep–wake regulation.
Absorption is characterized by moderate oral bioavailability with peak plasma concentrations typically occurring within several hours. The R‑enantiomer exhibits a longer elimination half‑life than racemic modafinil, contributing to sustained plasma exposure. Armodafinil undergoes hepatic metabolism involving multiple cytochrome P450 pathways and has been reported to induce CYP1A2, CYP2B6, and CYP3A isoenzymes while inhibiting CYP2C19 and CYP2C9 to varying degrees. These properties require attention to potential drug–drug interactions, particularly with substrates of these enzymes. Elimination occurs mainly via renal excretion of metabolites.
Common adverse effects include headache, nausea, and insomnia. Rare but clinically significant risks include serious rash and hypersensitivity reactions, psychiatric symptoms, and cardiovascular events, particularly in patients with underlying cardiac disease. Use should be guided by clinical monitoring and evaluation of comorbid conditions.
Armodafinil is marketed in several regions under brands such as Nuvigil. For API procurement, sourcing should prioritize manufacturers with demonstrated control of enantiomeric purity, impurity profiles, and compliance with regional regulatory and pharmacopoeial requirements to ensure consistent quality and suitability for finished dosage formulation.
Identification & chemistry
| Generic name | Armodafinil |
|---|---|
| Molecule type | Small molecule |
| CAS | 112111-43-0 |
| UNII | V63XWA605I |
| DrugBank ID | DB06413 |
Pharmacology
| Summary | Armodafinil is a eugeroic agent thought to promote wakefulness primarily through inhibition of the dopamine transporter, which increases extracellular dopamine levels. Although its precise mechanism is not fully defined, it does not act as a direct or indirect dopamine receptor agonist and shows minimal interaction with other receptors involved in sleep–wake regulation. Its pharmacologic profile supports investigation across disorders characterized by impaired alertness or dysregulated wakefulness. |
|---|---|
| Mechanism of action | Nuvigil (armodafinil) is a single-isomer of modafini. The exact mechanism of action is unknown. Armodafinil belongs to a class of drugs known as eugeroics, which are stimulants that provide long-lasting mental arousal. Pharmacologically, armodafinil does not bind to or inhibit several receptors and enzymes potentially relevant for sleep/wake regulation. Armodafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, both armodafinil and modafinil bind to the dopamine transporter and inhibit dopamine reuptake. [Medilexicon] |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent dopamine transporter | Humans | antagonist, inhibitor |
ADME / PK
| Absorption | Tmax is 2 hours when fasted and can be delayed approximately 2-4 hours by food, potentially affecting the onset of action. |
|---|---|
| Half-life | Terminal half-life is approximately 15 hours. |
| Protein binding | Specific data unavailable. Similar to modafinil: approximately 60%, primarily to albumin. |
| Metabolism | In vitro and in vivo data show that armodafinil undergoes hydrolytic deamidation, S-oxidation, and aromatic ring hydroxylation, with subsequent glucuronide conjugation of the hydroxylated products. Amide hydrolysis is the single most prominent metabolic pathway, with sulfone formation by cytochrome P450 (CYP) 3A4/5 being next in importance. The other oxidative products are formed too slowly in vitro to enable identification of the enzyme(s) responsible. Only two metabolites reach appreciable concentrations in plasma (i.e., R-modafinil acid and modafinil sulfone). Data specific to armodafinil disposition are not available. |
| Volume of distribution | Apparent volume of distribution: 42L. |
| Clearance | The oral clearance of armodafinil is approximately 33 mL/min. |
Formulation & handling
- Oral small‑molecule API with moderate lipophilicity and low aqueous solubility, suitable for conventional tablet formulations without specialized delivery systems.
- Food can delay absorption but does not impact overall exposure, so formulation generally focuses on standard disintegration and dissolution performance rather than food‑effect mitigation.
- Solid‑state handling is straightforward; the API is stable under typical manufacturing conditions with no peptide/biologic sensitivity considerations.
Regulatory status
| Lifecycle | The API’s U.S. market exclusivity has ended, with its most recent patents expiring in mid‑2024. In the U.S. market it is now in a late‑lifecycle, mature stage with no remaining patent protection. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Armodafinil appears to originate from a single innovator source, with branded products primarily established in the United States and limited evidence of broader global brand presence. Key U.S. patents have already expired, including two that lapsed in 2024, indicating that generic manufacturing either exists or is expected to expand. This positions the molecule in a post‑patent environment with increasing multisource supply potential. |
|---|
Armodafinil is a type of Psychostimulants
Psychostimulants are a specific subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that have gained significant attention in the medical field. These compounds are known for their stimulating effects on the central nervous system, making them valuable for treating various conditions such as attention deficit hyperactivity disorder (ADHD), narcolepsy, and certain cases of depression.
The primary mechanism of action of psychostimulants involves increasing the levels of certain neurotransmitters in the brain, particularly dopamine and norepinephrine. This heightened neurotransmitter activity results in enhanced cognitive functions, improved focus, and increased alertness. The most commonly prescribed psychostimulants include methylphenidate and amphetamines.
Methylphenidate is a well-known psychostimulant that works by blocking the reuptake of dopamine and norepinephrine, thereby increasing their concentrations in the synaptic cleft. This leads to improved concentration and reduced impulsivity in individuals with ADHD. Similarly, amphetamines stimulate the release of these neurotransmitters while also inhibiting their reuptake.
Psychostimulants are typically administered orally in the form of tablets or capsules, allowing for controlled and sustained release of the medication. These APIs undergo rigorous quality control measures to ensure their purity, potency, and safety.
In conclusion, psychostimulants are a specialized class of pharmaceutical APIs that effectively stimulate the central nervous system, leading to improved cognitive functions and reduced symptoms associated with ADHD, narcolepsy, and certain cases of depression. Their mechanisms of action involve enhancing neurotransmitter activity in the brain, particularly dopamine and norepinephrine. By adhering to strict quality control standards, these psychostimulant APIs provide safe and effective treatment options for patients in need.
Armodafinil (Psychostimulants), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Armodafinil API manufacturers & distributors
Compare qualified Armodafinil API suppliers worldwide. We currently have 8 companies offering Armodafinil API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Actavis Group | Producer | Iceland | Unknown | CoA, USDMF | 7 products |
| Acura Labs | Producer | India | India | CoA, GMP, MSDS, WC | 18 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CoA, GMP, WC | 40 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, USDMF, WC | 44 products |
| PLIVA | Producer | Czech Republic | Croatia | CoA, GMP | 31 products |
| Sigma-Aldrich | Producer | United States | Unknown | CoA, USDMF | 13 products |
When sending a request, specify which Armodafinil API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Armodafinil API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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