Generic product launch announcement: can we mention the original brand name?

  • Can a generic company make mention of the original brand name in their launch announcement communication to HCPs? We would like to explore two scenarios: one in which the original brand is no longer manufactured and our communication announces the launch of a generic so that docs can keep their patients on the same pill as the original molecule and a scenario in which the original brand is still available for purchase?

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  • @akar Great question.

    Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space.

    If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”.

    In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues.

    Any messages relating to switching will require support from the TMA or standard setting organizations.