A generic product is the bioequivalent of a pharmaceutical originator product that has already been on the market for several years.
In most countries, new pharmaceuticals enjoy patent protection
for a period of 20 years. When the patent expires, other companies
holding the appropriate licenses are entitled to manufacture and
market the pharmaceutical, provided they comply with the applicable
laws and regulations.
A generic pharmaceutical contains the same active substances as
the originator product. Once therapeutic bioequivalence has been
established, the generic product is substitutable for the
Generic medicines offer the same quality and safety profiles as
the originator products. Throughout their development and
production processes, generics must adhere to the same rigorous
standards of quality, safety and efficacy as the originator
products. These standards are closely monitored and enforced by the
relevant regulatory authorities both prior to and after product
approval. Manufacturing plants are regularly inspected to ensure
that they remain cGMP-compliant (current Good Manufacturing
Practice), while products on the market are regularly monitored to
ensure they continue to meet the quality standards.