Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
With the enactment of the Pharmaceutical Drug Price Reduction Act in October 2019, the strategy of a brand company introducing an Authorized Generic (AG) has become much less economically feasible.  The number of AGs launched has dropped significantly from around 100/year to just a handful in 2021.  As such, some brands are thinking of submitting ANDAs for a generic version of their brand drug. 

Has anyone followed this strategy?  Would a full new ANDA be required (3 new exhibit batches, stability, etc) or would referencing the NDA and providing new labeling be sufficient?  I feel like the solution would be somewhere in-between.  Getting concurrence from FDA/OGD is critical, and I'm struggling with asking the right questions for the meeting package.

Thoughts?  

Thank you!

This message was posted by a user wishing to remain anonymous

If the branded product loses exclusivity and if the branded company wish to submit an ANDA? Its the same as AG. You just refer everything to the approved NDA because the owner/sponsor of the NDA is same as the ANDA sponsor.
Original Message:
Sent: 29-Apr-2022 11:39
From: Anonymous Member
Subject: Submitting an ANDA for an AG

This message was posted by a user wishing to remain anonymous

Hello,
With the enactment of the Pharmaceutical Drug Price Reduction Act in October 2019, the strategy of a brand company introducing an Authorized Generic (AG) has become much less economically feasible.  The number of AGs launched has dropped significantly from around 100/year to just a handful in 2021.  As such, some brands are thinking of submitting ANDAs for a generic version of their brand drug.

Has anyone followed this strategy?  Would a full new ANDA be required (3 new exhibit batches, stability, etc) or would referencing the NDA and providing new labeling be sufficient?  I feel like the solution would be somewhere in-between.  Getting concurrence from FDA/OGD is critical, and I'm struggling with asking the right questions for the meeting package.

Thoughts?

Thank you!

Interesting question. 

Can a company submit an ANDA referencing its own NDA RLD? I did not think that was possible. If it was possible, wouldn't all brand companies do this to avoid the PDUFA annual product fees of ~$370K/product?

------------------------------
Cynthia Katsempris
Director, Regulatory Affairs
Lebanon NJ
United States
------------------------------

Original Message:
Sent: 29-Apr-2022 18:04
From: Anonymous Member
Subject: Submitting an ANDA for an AG

This message was posted by a user wishing to remain anonymous

If the branded product loses exclusivity and if the branded company wish to submit an ANDA? Its the same as AG. You just refer everything to the approved NDA because the owner/sponsor of the NDA is same as the ANDA sponsor.
Original Message:
Sent: 29-Apr-2022 11:39
From: Anonymous Member
Subject: Submitting an ANDA for an AG

This message was posted by a user wishing to remain anonymous

Hello,
With the enactment of the Pharmaceutical Drug Price Reduction Act in October 2019, the strategy of a brand company introducing an Authorized Generic (AG) has become much less economically feasible.  The number of AGs launched has dropped significantly from around 100/year to just a handful in 2021.  As such, some brands are thinking of submitting ANDAs for a generic version of their brand drug.

Has anyone followed this strategy?  Would a full new ANDA be required (3 new exhibit batches, stability, etc) or would referencing the NDA and providing new labeling be sufficient?  I feel like the solution would be somewhere in-between.  Getting concurrence from FDA/OGD is critical, and I'm struggling with asking the right questions for the meeting package.

Thoughts?

Thank you!

This message was posted by a user wishing to remain anonymous

They still need to pay the fees!  If the branded NDA company authorizes a generic company to refer to the branded NDA for approval, the generic company pays the generic ANDA fees. I think that the OP is asking what if the branded NDA company and the generic company are the same. The generic ANDA fees needs to be paid!
Original Message:
Sent: 03-May-2022 10:13
From: Cynthia Katsempris
Subject: Submitting an ANDA for an AG

Interesting question.

Can a company submit an ANDA referencing its own NDA RLD? I did not think that was possible. If it was possible, wouldn't all brand companies do this to avoid the PDUFA annual product fees of ~$370K/product?

------------------------------
Cynthia Katsempris
Director, Regulatory Affairs
Lebanon NJ
United States

Original Message:
Sent: 29-Apr-2022 18:04
From: Anonymous Member
Subject: Submitting an ANDA for an AG

This message was posted by a user wishing to remain anonymous

If the branded product loses exclusivity and if the branded company wish to submit an ANDA? Its the same as AG. You just refer everything to the approved NDA because the owner/sponsor of the NDA is same as the ANDA sponsor.
Original Message:
Sent: 29-Apr-2022 11:39
From: Anonymous Member
Subject: Submitting an ANDA for an AG

This message was posted by a user wishing to remain anonymous

Hello,
With the enactment of the Pharmaceutical Drug Price Reduction Act in October 2019, the strategy of a brand company introducing an Authorized Generic (AG) has become much less economically feasible.  The number of AGs launched has dropped significantly from around 100/year to just a handful in 2021.  As such, some brands are thinking of submitting ANDAs for a generic version of their brand drug.

Has anyone followed this strategy?  Would a full new ANDA be required (3 new exhibit batches, stability, etc) or would referencing the NDA and providing new labeling be sufficient?  I feel like the solution would be somewhere in-between.  Getting concurrence from FDA/OGD is critical, and I'm struggling with asking the right questions for the meeting package.

Thoughts?

Thank you!