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Re:How MDMA Went from Club Drug to ‘Breakthrough Therapy’ by refurb on Thursday October 19, 2017 @03:13PM (#15510734)
The first chemical entity approved by the FDA gets data exclusivity - that is, no other company is allowed to use the originator's data to get their generic approved. I think the standard is 5 years, with rare disease drugs getting 7 year.

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