What happens when a patent expires on a branded drug?

A generic drug is a pharmaceutical that contains the same chemical substance as a drug that was originally branded and protected by patents, but once they expire, duplicates are often allowed for sale as so-called generics.

Some characteristics such as the manufacturing process, formulation, color, taste, and packaging may slightly differ, but given that the active pharmaceutical ingredient (API) is the same, the medical profile of generics is believed to be equivalent in performance to the original and therefore its route to market it much quicker.

In order to market them, manufacturers must still conduct studies to determine whether their version is bioequivalent to the original drug; specifically, that its active ingredient releases into the bloodstream at virtually the same speed and amount, but as the original was already proven safe, the testing is much quicker and requires a much smaller clinical study.

QUINTA-ANALYTICA’s bioanalytical department has vast experience in drug testing, and has developed and validated over 300 bioanalytical methods for APIs under GLP, GMP, and ICH/FDA and EMEA directives.

Get in touch with us today to discuss your testing needs.

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