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Looking at the status quo of new drug research and development, it is still "difficult". The long cycle, huge cost and high risk have already become the "features" inherent in the development of new drugs. It is not difficult to see that the 20-year patent protection period for new drugs has been used most of the time in the development and registration of new drugs, not in the sales phase.
Therefore, in order to recover the R&D costs as much as possible, brand drug manufacturers will authorize generic drugs as the original market share of some brand drugs to make up for the R&D investment of brand drugs. The introduction of authorized generic drugs can enable consumers to use drugs with higher cost performance, which also allows brand drug manufacturers to take away some of the generic drug market share that should belong to independent generic drug manufacturers.
Indeed, studies abroad have shown that generic drugs can account for about 25% of the total generics market sales within five years of generic competition. Of course, whether it is authorized generics or stand-alone generics, the first generics listed will give producers the most profit.
Only branded drug manufacturers can take advantage of their own advantages, allowing them to authorize generic drugs to become the first product in the generic drug market, providing a time advantage for brand drug manufacturers to lay out in the generic drug market. In addition, authorized generic drugs can also allow brand drug manufacturers to fully utilize their own production equipment even after the patent expires, further reducing production costs and expanding competitive advantage.
The status quo of new drug research and development is still "difficult"
Zyzhan Guide: The latest research estimates that the development of a new drug takes an average of 10 to 15 years and costs more than $1.3 billion. In the United States, for example, only 5,000 to 10,000 screened compounds can enter preclinical studies, five enter clinical trials, and only one can receive FDA approval for marketing.