Dr John Kruse
Dr John Kruse
@drjohnkruse·16.8K subscribers·467 videos

Generic Medications - Problem or Solution?

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February 5, 2026

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Prior to 1984, generic drugs in the US had to undergo the same application process as brand name drugs, demonstrating safety and efficacy. Consequently they made up less than 20% of the medication market. The Hatch-Waxman Act changed the rules, so that generic drugs now only need to show that they bioequivalent to brand name drugs. Now 90% of medications consumed in the US are generic.

Generics must contain the active ingredient of the drug, but are actually (by trademark law) required to look different. They may also have different colorants or other “inactive” ingredients. Bioequivalence is measured by the peak concentration and the total amount of drug delivered, and the generic levels can be as low as 80% and as high as 125% of the brand name product.

Generic drugs can provide huge cost savings, since the company generally needs to cover just manufacturing costs, not research, development and marketing. But generic versions of medications whose action is very sensitive to peak concentrations, or the rate of absorption, may result in different experiences for patients. In psychiatry the generic drugs for which patients most frequently report problems include the stimulants (versions of Adderall and Ritalin) and the anti-anxiety benzodiazepines (Valium, Xanax, Ativan, and others.)

For many drugs, multiple pharmaceutical companies produce generic versions. An individual who has problems with one manufacturer’s product (which is required to be identified on the pill bottle label) can request that the company’s product be avoided on subsequent fillings.

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References:

FDA Bioequivalence Guide

Generic Drugs in the United States: Policies to Address Pricing and Competition (2019)

‘Inactive’ ingredients in oral medications (2019)

Bupropion Hydrochloride Extended-Release 300 mg Bioequivalence Studies (2014)

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Psychiatrist, neuroscientist, and author John Kruse, MD, PhD presents practical, actionable, well-researched information about treatment options that scientists and clinicians recommend for adult ADHD and other mental health conditions.

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Guests & Subjects Covered

Problem or Solution?Main Chapters IntroGeneric Medications TakeGenerics ContextBrand NameHatch-Waxman Act ProblemsGeneric Medications Conclusion PriorThe Hatch-Waxman Act

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Generic Medications - Problem or Solution? · Dr John Kruse · Sentinel