<P> Another element of complexity is that all estimates are based on confidential information controlled by drug companies, released by them voluntarily, leading to inability to verify costs . The numbers are controversial, as drug companies use them to justify the prices of their drugs and various advocates for lower drug prices have challenged them . The controversy is not only between "high" and "low", but also the high numbers may vary considerably for the manifold factors in drug development . </P> <P> One study assessed both capitalized and out - of - pocket costs as about US $1.8 billion and $870 million, respectively . </P> <P> In an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single - drug company was $350 million . But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion, due mainly to geographic expansion for marketing and ongoing costs for Phase IV trials and continuous monitoring for safety . </P> <P> Alternatives to conventional drug development have the objective for universities, governments and pharmaceutical industry to collaborate and optimize resources . </P>

How much does it cost to develop a new drug in the us
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