Generic Drugs Market: Wide Application Area to
Propel Demand By 2026
Generic drugs refers to medication that have the same active ingredient as that of a branded
drugs. These drugs also yield the same therapeutic effect and are prescribed in the same dosing,
with the same quality, and same the way of consumption and usage. However, the inactive
ingredients of generic drugs can differ as compared to their branded counter parts. These drugs
are mainly marketed after a patent expiry of a branded drug and are significantly lower in
costs as compared to the patented branded drugs. Generic drugs are of equivalent quality as
compared to the branded drugs and are manufactured under the same safety and manufacturing
procedures. Various manufacturers submit an abbreviated new drug application (ANDA) to the
FDA after the completion of period of patent exclusivity.
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Patent expiry of branded drugs is a factor expected to boost growth of the global generic drugs
market:
Manufacturers of generic drugs are focusing on development and introduction of various
innovative medication and formulation such as biosimilars. According to IMS Health data,
generic drugs accounted for over 80% of the prescriptions dispensed in the U.S. in 2013. The
number of patents expiring in the near future serves to be a major driver for growth of generic
drugs market. For instance, Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor
that is indicated in the treatment of metastatic colorectal cancer and head and neck cancer. It
is manufactured under the patent by Bristol-Myers Squibb and Eli Lily Company in Europe. The
drug’s patent expires in 2018 and thus, is expected to provide opportunity for a large number
of market players to manufacture its generic version. Furthermore, supportive initiative by FDA
to promote development of biosimilars is encouraging manufacturers to focus towards its
development. For instance, the Biologics Price Competition and Innovation Act in the U.S. gr
ants 12 months patent exclusivity with higher profit margins to the first manufacturer than the
conventional generic manufacturers bringing the drugs in market later. Various other factors
contributing to growth of generic drugs market include rampant growth in incidence of chronic