Hi Chang,
Thank you for your prompt reply.
Indeed, the correct answer was not among the choices (which reminds me of some exams I sat during my academic years... =D).
Back to the topic, by now you understood the main issue behind my question relates to the "first applicant(s)".
First, FDA considers the date an ANDA containing a paragraph IV certification is submitted to be the date the ANDA is "received" pursuant to 21 CFR 314.101(b), i.e.
accepted for review.
When an ANDA containing a paragraph IV certification is determined, upon review, to have been substantially complete as of the day it was submitted to FDA, it will be deemed to have been received as of the date it was submitted (i.e.,
date-stamped by the appropriate FDA mail-room).
When OGD sends the applicant a refusal to receive letter describing the additional information that must be submitted to render an ANDA substantially complete, the ANDA is deemed received
on the day the information necessary to find the application substantially complete was submitted.
Let's take our example back:
Drug Product X is approved on April 23, 2013 and is granted a 5-year exclusivity ending on April 23, 2018.
Generic Company A submits its ANDA with Paragraph IV certification on April 23, 2017 (date FDA acknowledged receipt of the ANDA). After review, FDA deems the ANDA complete and accepts it for filing on June 20, 2017. The date of submission for Generic Company A is still April 23, 2017.
Generic Company B submits its ANDA with Paragraph IV certification on April 23, 2017 (date FDA acknowledged receipt of the ANDA). After review, FDA finds deficiencies in the ANDA and deems it not acceptable for filing on June 20, 2017. Generic Company B then submits a complete response on June 30, 2017 (date FDA acknowledged receipt of the complete response). After review, FDA deems the ANDA complete and accepts it for filing on July 10, 2017. The date of submission for Generic Company B is June 30, 2017.
Generic Company C submits its ANDA with Paragraph IV certification on February 14, 2017 (date FDA acknowledged receipt of the ANDA). After review, FDA deems the ANDA complete, but cannot accept it for filing as of April 14, 2017. FDA will accept the ANDA for filing on April 23, 2017. The date of submission for Generic Company C is April 23, 2017.
As you can see, both Generic Company A and C have the same filing date and are considered first applicants. However, Generic Company C had an advantage, as in if the FDA were to find deficiencies in the ANDA, Generic Company C would still be able to submit a complete response before or on April 23, 2017 and thus retains its first applicant status.
However, from what you said, the situation of Generic Company C is not possible since '"submission" refers to the process (application) that you are submitting data to FDA for the review and ultimate approval of a generic drug product.' Thus, FDA will not "acknowledge" Generic Company C submission of February 14, 2017.
Regards,
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Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
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Original Message:
Sent: 04-23-2013 13:14
From: Chang Lim
Subject: NCE exclusivity
Tom:
As for an NCE exclusivity, there are patent-related (4 or 5 years) or non-patent related (3 years).
The term "submission" refers to the process (application) that you are submitting data to FDA for the review and ultimate approval of a generic drug product.
If an NCE exclusivity (5 years) ends on April 23, 2018, your ANDA (1st ANDA); with Class IV Certification; 4 years) can be filed on April 23, 2017.
A case example:
Lunesta:
NDA (1st): 12/15/04
NCE exclusivity ended: 12/15/09
ANDA (1st) filed: 12/15/08
You didn't give us any chance to choose the right answer as the right answer wasn't provided among the options.
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Original Message:
Sent: 04-23-2013 12:17
From: Tom Namsavanh
Subject: NCE exclusivity
Hello,
A 5-year exclusivity prevents the submission of an application referring to the exclusivity holder data (or 4 years if a paragraph IV certification is included). In this context, what does "submission" mean?
Example: Drug Product X is approved on April 23, 2013 and is granted a 5-year exclusivity ending on April 23, 2018.
Generic Company A would like to file an ANDA with a Paragraph IV certification. What is the date Generic Company A can submit its application?
1) The ANDA can only be filed on April 24, 2017. The FDA will then review the application for completeness and either accept or refuse the application for filing;
or
2) The ANDA can be filed before April 23, 2017. The FDA can review the application for completeness, but cannot accept the application for filing until April 24, 2017.
Thanks a lot,
-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
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