Tag: generic drugs
Bioequivalence Studies: What the FDA Requires Generic Drug Manufacturers to Prove
Bioequivalence studies prove generic drugs work the same as brand-name versions. The FDA requires strict testing to ensure identical absorption and effectiveness, using the 80-125% rule for most drugs. This process keeps generics safe, affordable, and reliable.
When Do Drug Patents Expire? Understanding the 20-Year Term and Real-World Timeline
Drug patents last 20 years from filing, but most drugs face generic competition in 7-12 years due to FDA approval delays. Patent extensions, regulatory exclusivity, and layered patents shape when prices drop.
Long-Term Safety of Generic vs. Brand Drugs: What the Data Really Shows
Long-term safety studies show generics are often just as safe as brand drugs - and sometimes safer due to better adherence. But for critical medications like thyroid or seizure drugs, small differences can matter. Here’s what the data really says.
Generics vs Brand-Name Drugs: What Insurance Covers and Why It Matters
Discover how insurance plans treat generic and brand-name drugs differently, why generics cost less, and what you can do when a generic doesn't work for you. Learn about formulary tiers, substitution rules, Medicare policies, and how to appeal coverage denials.