Regulatory Open Forum

Hello, 
Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees.

Is this possible? I did not think you could do this, but someone else has suggested this strategy to me.

Thanks

------------------------------
Cynthia Katsempris
Director, Regulatory Affairs
Lebanon NJ
United States
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This message was posted by a user wishing to remain anonymous

Once the 505b2 NDA loses its exclusivity/patent, yes an ANDA is possible.
Original Message:
Sent: 03-May-2022 09:58
From: Cynthia Katsempris
Subject: "Genericizing" your NDA 505b2

Hello,
Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees.

Is this possible? I did not think you could do this, but someone else has suggested this strategy to me.

Thanks

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

An authorized generic is what you are being told about.  Authorized generics is a strategy wherein the company produces the equivalent of its own branded drug under a different private label and at a slightly lower price. It is usually a strategy to retain market share from generic products. You don't need to file an ANDA, but just notify FDA that you are marketing an authorized generic. You can read about them here:  https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 03-May-2022 09:58
From: Cynthia Katsempris
Subject: "Genericizing" your NDA 505b2

Hello,
Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees.

Is this possible? I did not think you could do this, but someone else has suggested this strategy to me.

Thanks

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

This message was posted by a user wishing to remain anonymous

Hello Mr. Park

As marketing of authorized generics (AG) is not dependent on patent term expiration,  I wanted to know when is the right time for a brand name manufacturer to introduce an AG version of its branded drug (at a slightly lower cost)- before or after patent term expiration? 
I was wondering if it is after the patent expires, it would be competing with actual generics which (as I researched) are priced much lower than AGs.
Insights would be helpful!


Original Message:
Sent: 04-May-2022 08:12
From: Glen Park
Subject: "Genericizing" your NDA 505b2

An authorized generic is what you are being told about.  Authorized generics is a strategy wherein the company produces the equivalent of its own branded drug under a different private label and at a slightly lower price. It is usually a strategy to retain market share from generic products. You don't need to file an ANDA, but just notify FDA that you are marketing an authorized generic. You can read about them here:  https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 03-May-2022 09:58
From: Cynthia Katsempris
Subject: "Genericizing" your NDA 505b2

Hello,
Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees.

Is this possible? I did not think you could do this, but someone else has suggested this strategy to me.

Thanks

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

If you submit an ANDA against your own product, it would likely be considered an authorized generic, since you would have to waive any exclusivity granted to your 505B2.  Also, even if this works, there is an annual product fee now for generics so you would not get out of paying something each year to maintain your product.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Nipomo CA
United States
------------------------------

Original Message:
Sent: 03-May-2022 09:58
From: Cynthia Katsempris
Subject: "Genericizing" your NDA 505b2

Hello,
Does anyone know of any precedence for a company submitting an ANDA against your own NDA 505b2. Then, once the ANDA is approved you discontinue the NDA product, in essence then avoiding the PDUFA annual product fees.

Is this possible? I did not think you could do this, but someone else has suggested this strategy to me.

Thanks

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