Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

This message was posted by a user wishing to remain anonymous

No!
Original Message:
Sent: 10-Aug-2022 12:37
From: Anonymous Member
Subject: 505(b)(2) Drug Approval and Exclusivity

This message was posted by a user wishing to remain anonymous

Hello, 

If company A gets drug #1 approved under a 505(b)(2) and is granted exclusivity, can company B submit a 505(b)(2) for drug #2 based on drug #1's approval, even if drug #1 is still under FDA exclusivity?

Thank you kindly

A 505(b)(2) application is based on the reference to studies performed by the owner of the reference drug. Since Company A does not own the data from the reference drug you cannot use their approval as the basis of your application. Depending on the situation, e.g., violation of Company A exclusivity, you might be able to submit an application referencing the originator's approval.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 10-Aug-2022 12:37
From: Anonymous Member
Subject: 505(b)(2) Drug Approval and Exclusivity

This message was posted by a user wishing to remain anonymous

Hello, 

If company A gets drug #1 approved under a 505(b)(2) and is granted exclusivity, can company B submit a 505(b)(2) for drug #2 based on drug #1's approval, even if drug #1 is still under FDA exclusivity?

Thank you kindly

This message was posted by a user wishing to remain anonymous

Company A is given exclusivity which means that company A has done original clinical study (s) so from RA perspective Company B can reference to the Company A's approval for which the clinical study was used as basis of NDA. However, the situation as described above by the OP is, company A drug is still under exclusivity and therefore Company B cannot file 505b2 NDA referencing Company A's NDA.
Original Message:
Sent: 11-Aug-2022 10:42
From: Glen Park
Subject: 505(b)(2) Drug Approval and Exclusivity

A 505(b)(2) application is based on the reference to studies performed by the owner of the reference drug. Since Company A does not own the data from the reference drug you cannot use their approval as the basis of your application. Depending on the situation, e.g., violation of Company A exclusivity, you might be able to submit an application referencing the originator's approval.

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

Original Message:
Sent: 10-Aug-2022 12:37
From: Anonymous Member
Subject: 505(b)(2) Drug Approval and Exclusivity

This message was posted by a user wishing to remain anonymous

Hello, 

If company A gets drug #1 approved under a 505(b)(2) and is granted exclusivity, can company B submit a 505(b)(2) for drug #2 based on drug #1's approval, even if drug #1 is still under FDA exclusivity?

Thank you kindly

Per FDA - No 505(b)(2) application or ANDA may be submitted during the 5-year exclusivity (NCE) period except that such applications may be submitted after 4 years if they contain a certification of patent invalidity or noninfringement.

------------------------------
Len Smith
Counsel (Patents/IP/Contract/Regulatory)
Scottsdale AZ
United States
------------------------------

Original Message:
Sent: 10-Aug-2022 12:37
From: Anonymous Member
Subject: 505(b)(2) Drug Approval and Exclusivity

This message was posted by a user wishing to remain anonymous

Hello, 

If company A gets drug #1 approved under a 505(b)(2) and is granted exclusivity, can company B submit a 505(b)(2) for drug #2 based on drug #1's approval, even if drug #1 is still under FDA exclusivity?

Thank you kindly