Provigil (Modafinil)

Provigil is the original reference listed drug (RLD) brand for modafinil, developed to manage severe daytime sleepiness. Initially brought to market by Cephalon and later acquired by Teva Pharmaceutical Industries, this page provides an educational background on Provigil’s manufacturing history, regulatory credentials, and its standing within global pharmaceutical networks.

First FDA Approval Year (Originally Developed by Cephalon)

Global Pharmaceutical Entity (Under Teva Leadership)

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International Regulatory Authorizations

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Manufacturer

Teva Pharmaceuticals / Cephalon

Strength

100mg & 200mg (Modafinil API)

Quantity

30 Tablets Per Box

Regulatory Status

Prescription-Only Medicine (POM)

What is the Pharmacological Profile & Specifications of Provigil?

Provigil (Modafinil 200mg) is the original innovator drug formulation. Below are the specific pharmaceutical properties, excipient profiles, and systemic characteristics that define authentic Provigil.

1. Inactive Ingredients & Excipients

Each authentic Provigil 200mg tablet is formulated with specific inactive pharmaceutical binding agents: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, croscarmellose sodium, povidone K29/32, and magnesium stearate. Patients with severe lactose intolerance should take note of this specific excipient profile when comparing Provigil to generic alternatives.

2. Pharmacokinetics & Peak Absorption (Tmax)

Following oral administration, Provigil is rapidly absorbed, reaching peak plasma concentration (Tmax) within 2 to 4 hours. Because Provigil is the Reference Listed Drug (RLD) approved under US FDA NDA #020717 and UK MHRA frameworks, its area under the curve (AUC) and rate of absorption serve as the official bioequivalence benchmark for all generic modafinil products worldwide.

3. Metabolic Clearance & Half-Life

Provigil exhibits an elimination half-life of approximately 12 to 15 hours in healthy adults. Metabolism occurs primarily in the liver via hydrolytic ester cleavage and hepatic CYP3A4 pathways, yielding two main inactive circulating metabolites (modafinil acid and modafinil sulfone) which are subsequently excreted by the kidneys.

4. Packaging, Serialization & Storage

Genuine Provigil is supplied in tamper-evident PVC/PVDC aluminum blister packaging (typically 30 tablets per box) engineered to protect the active ingredient from ambient humidity. Every authentic box of modafinil features a unique manufacturer batch code, expiration date, and National Drug Code (NDC) or regional Marketing Authorization identifier for complete supply chain traceability.

More About Provigil

Brand History

Global Foundation and Growth

Provigil was initially introduced by Cephalon, Inc., a pioneer in eugeroic compounds that was founded in 1987. Cephalon then revolutionized wakefulness-promoting therapy. By focusing on selective central nervous system targeting rather than broad systemic stimulation, Cephalon established Provigil as the gold-standard reference drug across North America and Europe.

The Teva Corporate Integration

In a major pharmaceutical acquisition, Cephalon was integrated into Teva Pharmaceutical Industries, forming one of the largest drug supply chains globally. Today, Provigil batch production adheres to stringent international Good Manufacturing Practice (GMP) standards, ensuring strict bioequivalence and chemical consistency across authorized supply networks.

Trusted UK Presence

Throughout the UK and global medical sectors, Provigil remains a fundamental reference brand documented in major national formularies (such as the BNF). Because its chemical profile and manufacturing protocols are rigorously documented by global health authorities, it serves as the benchmark against which generic modafinil formulations are evaluated. Stay tuned with Modafinil UK to get regular updates about the latest brands like Provigil associated with modafinil.

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Frequently Asked Questions

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How Can I Get Provigil Online?

In the UK, Provigil® (modafinil) is a Prescription Only Medicine (POM). To obtain it online legally, you must first complete a consultation with a registered prescriber or upload a valid prescription to a licensed UK pharmacy. Once approved, the pharmacy dispenses the medicine through the regulated medicines supply chain. Buying Provigil from unverified websites increases the risk of receiving counterfeit or poor-quality products.

What Is the Cost of Provigil Without Insurance?

The price of Provigil without insurance varies depending on the pharmacy, tablet strength, pack size, and whether the medicine is the original brand or a generic equivalent. In the UK, private prescriptions usually cost considerably more than NHS prescriptions because patients pay the full medicine price. Generic modafinil is often less expensive than branded Provigil while meeting the same quality standards required by UK regulators.

Is Provigil Used for ADHD?

Provigil is not licensed in the UK for treating ADHD. Although some specialists have studied modafinil as an off-label option for people who cannot tolerate conventional ADHD medicines, methylphenidate and lisdexamfetamine remain the recommended first-line stimulant treatments under NICE guidance. Any off-label use should be considered only by an experienced specialist after a full clinical assessment.

Can Provigil Be Used for Multiple Sclerosis (MS) Fatigue?

Yes, Provigil may sometimes be prescribed off-label for fatigue associated with multiple sclerosis (MS), although this is not a licensed indication in the UK. Some patients report improved daytime alertness and mental stamina, while clinical studies have shown mixed results. Specialists weigh the potential benefits against possible side effects before recommending modafinil for MS-related fatigue.

What Are Some Prescription Drugs like Provigil?

Several medicines have effects similar to Provigil, although they belong to different drug classes and are prescribed for different conditions. Modafinil is available as a generic alternative to branded Provigil. Other wakefulness-promoting medicines include pitolisant and solriamfetol, both used for selected patients with narcolepsy. Traditional CNS stimulants such as methylphenidate, lisdexamfetamine, and dexamfetamine also improve alertness and attention, but they work through different mechanisms and are mainly prescribed for ADHD rather than excessive daytime sleepiness.

Written By:

Matthew Young

Medical Writer at Modafinil UK

Hi, I’m Matthew Young, a medical writer and editor based in the United Kingdom. I’m currently researching modafinil medicines, including Provigil, Milpharm Modafinil, Teva Modafinil, Accord Healthcare Modafinil, Brown & Burk UK Modafinil, Generic Modafinil and other brands, with a focus on medicine identification, regulatory guidance, product quality, safe usage, patient safety, and so on. My work combines medical literature, manufacturer information, and UK healthcare guidance to produce accurate, evidence-based articles that are easy to understand.