Generic Drugs Have Major Market Share By Volume, but not by Total Sales

U.S. patent policy typically grants drug manufacturers the normal 20 years’ protection from the date of the original patent (which is most likely filed very early in the research process), plus a period of 14 years after FDA approval. Once the patent on an existing drug expires, competing drug companies may be allowed to market cheaper generic versions which are nearly identical chemical compounds. (However, the FDA must approve the generic version, which may require several years of effort and a substantial financial investment on the part of the generic manufacturer. Also, the original owner of a drug patent may attempt to extend protection of the drug for many years by continually filing additional patents based on newer formats, delivery methods or uses for a drug. Drug owners that sell in large quantities are willing to go to extensive efforts to try to maintain at least some level of patent protection.)

Generic prescriptions as a percentage of all U.S. pharmaceutical sales rose from 49% by volume in 2000 to 90% by 2020 (but accounted for a significantly lower percentage of total drug expenditures). Some drugs sell in such low volume that they aren’t taken up by generic manufacturers even though they have gone off-patent.

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Generic Drugs Have Major Market Share By Volume, but not by Total Sales, Business and Industry Trends Analysis

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