In 1993, the company will lose market exclusivity for its top-selling drug, Lopid, used in the prevention of heart disease.
Orphan drug status provides market exclusivity for a product in the United States for seven years.
Such market exclusivity can produce hundreds of millions of dollars in revenue for the manufacturer.
During this period of market exclusivity, the patent owner can recover the costs of its original investment.
Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition.
But under American pressure, Thailand had created a program that conferred the same market exclusivity.
Orphan drug status entitles a company to tax credits and seven years of "market exclusivity," or freedom from generic competition.
In this same context, the term genericization refers to the process of a brand drug losing market exclusivity to generics.
One of these incentives is market exclusivity for a period of 10 years.
The total combined duration of market exclusivity of a general patent and SPC cannot normally exceed 15 years.