Modified-release formulations require specialized bioequivalence testing to ensure generics work as well as brand-name drugs. Learn how regulators assess release profiles, dissolution, and partial AUCs-and why some generics still fail patients.
Modified-release formulations require specialized bioequivalence testing to ensure generics work as well as brand-name drugs. Learn how regulators assess release profiles, dissolution, and partial AUCs-and why some generics still fail patients.
Generic drugs cost 80-85% less than brand-name drugs because they don't need to repeat expensive clinical trials. They contain the same active ingredients, meet the same safety standards, and work just as well-saving patients billions each year.
The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug maker to challenge a patent a temporary monopoly. This law shapes drug prices, delays competition, and impacts patient access to affordable medications.