Q（Question）

When a physician or pharmacist requests a generic drug manufacturer to provide information on indications, dosage, or regimens approved for the originator drug but not for the generic due to re-examination periods, patent constraints, or other reasons, may the generic manufacturer provide such information?

A（MHLW answer）

It is permissible to inform the physician or pharmacist of the fact that the originator drug holds approval for certain indications, dosages, or regimens, while the generic drug does not.

However, providing substantive information on those indications, dosages, or regimens that only the originator drug holds approval for is not permitted.

Items requiring particular attention: (1), (4), (6), (7)

So what (meaning): A generic manufacturer may tell a healthcare professional that a given indication is approved for the originator but not for its own product; it may not go further and explain or promote that unapproved indication.

So why (rationale): Disclosing the approval gap as a fact is a neutral statement that aids prescribing decisions, whereas providing substantive off-label content would effectively promote unapproved use of the generic, violating items (1), (4), (6), and (7).

Commentary — background, application, practical notes

A 'gap indication' refers to a situation where a generic drug has not been approved for certain indications, dosages, or regimens that the originator drug holds, typically because the originator's re-examination period or patents remain in effect. For generic manufacturers, there is a clinical risk that physicians or pharmacists may prescribe the generic without awareness of the approval gap, creating a legitimate need for some form of information provision. This question establishes the boundary for how far that provision can go.

What is permitted is limited to factual notification: stating that the originator drug holds approval for a given indication while the generic does not. For example, using the package insert to explain to a physician which indications are unapproved for the generic product constitutes a factual disclosure of the gap and is permissible.

What is prohibited is going further and providing substantive information about the content of indications that only the originator holds. For instance, explaining 'the originator drug is approved for indication X, and here is the supporting evidence' amounts to providing off-label information for the generic—which the generic manufacturer's own product does not hold. In practice, when a physician asks for more detail about a gap indication, redirecting them to the originator company's medical representative is an acceptable response, but the generic company must not itself explain the unapproved indication. The distinction between disclosing the existence of the gap and explaining the content of the unapproved indication must be maintained at all times.