In 4Q17, Merck’s Zetia reported revenues of $323 million, which was ~44% lower on a year-over-year basis and a 1% rise on a quarter-over-quarter basis.
Mylan has been embroiled in a controversy over whether its EpiPen is classified as a generic or a branded product and whether its 500.0% price hike is justified.
The generic pharmaceutical industry is characterized by low concentration. The top ten global generic companies hold less than 50% of the market share.
A generic company is rewarded for a Para IV filing. The first applicant to submit a substantially completed ANDA is given marketing exclusivity for 180 days.
To overcome the issues of the costly and time consuming marketing authorization process, the Hatch-Waxman Act introduced the ANDA process to make approvals efficient.
The generics pharmaceutical industry is highly regulated. The drug approval process and the regulatory bodies governing them differ from market to market.
The US generics industry is fragmented. The top five companies accounted for 44.4% of the market share of unbranded generics in 2013, according to IMS Health.
The generics industry primarily caters to several large diseases in primary care. Healthcare is organized into three categories—primary, secondary, and tertiary.
The prescription drug market is divided into two categories—branded or generic drugs. Branded drugs are patented drugs. Generics are off-patented drugs.
