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When a new patented drug is applied to the FDA for marketing, it is necessary to submit relevant patent information, which will be registered in the Orange Book by the FDA.
The orange book patent submission standard stipulates that the patents that can be included in the orange book include active compounds, formulas, compositions, and pharmaceutical uses; however, manufacturing methods, outer packaging patents, metabolites, intermediates, etc.
These types of patents are also commonly used patent types in the layout of pharmaceutical patents.
Therefore, this article compares the Orange Book patents with medicines (in the statistics of medicines, the medicines of the same active ingredient and different dosage forms are separately counted) one-to-one correspondence, and select one or several patents whose patents have expired last, and count their expiry years .
This is also in line with a feature of drug patents: the safety and effectiveness test of the original drug before the market and the FDA approval process require a long time, making the application time for drug patents, especially core patents, much earlier than the drug market time.
It is precisely because of this situation that the United States introduced the Hatch-Waxman Act in 1984, which compensates for lost patent terms in the pre-market research and approval procedures of patented drugs.
In addition, the statistical results of the type of protection subject of expired patents show that the last expired patents of medicines are dominated by patents for preparations and medical purposes.
Through statistics on the expiration time of drug patents, combined with sales data and analysis of treatment fields, technologies, etc.
As many as 52 drug patents will expire in 2022, of which Alimta and Gleevec are over one billion varieties.
Therefore, the patent information of the Orange Book has irreplaceable reference and early warning significance for drug research and development projects, market forecasts, etc.
Note: The original text has been deleted
