Bioequivalence and Bioavailability Forum

Dear all,

Request the team members to suggest a list of molecules (other than the OTC molecules) accepted for bibliographic application in the EU.

Most generics are out in the market after completion of 8-10 years of marketing of the innovator product. Would not the timeline of 10 years qualify for a generic version (especially of the prototypes) to be classed as 'well-established use'. Which molecules are specifically granted MAA without any clinical study as 'well-established use'?

Thank the team in advance for the kind help.