FDA to provide new data regarding eligibility for 180-day exclusivity.

The FDA enhanced their Paragraph IV Patent Certifications list in efforts to improve approval times for generic drug applications, this past week. The Paragraph IV Patent Certifications list contains relevant information to eligibility for 180-day exclusivity for generic drug products for those who have submitted a substantially complete abbreviated new drug application (ANDA) containing a “paragraph IV (PIV) patent certification” to the FDA.

In the past, this list has included the name of the drug product, dosage form, strength(s), reference listed drug (RLD) new drug application (NDA) number, and the date on which the first substantially complete application containing a paragraph IV certification was submitted to the Agency.

Under the Agency’s Drug Competition Action Plan (DCAP), the ultimate goal of FDA is more approvals, thereby helping to increase access to high quality, lower cost generic drugs. On June 18, 2019, several points were added onto the Paragraph IV Patent Certifications list including the number of potential first applicants, status of the 180-day exclusivity, information pertaining to the first approval date, marketing status, and expiration date of the last qualifying patent. This information allows those applying for generic drug approval to determine when their drugs can be approved and marketed. More updated information can be found on the Paragraph IV Patent Certifications web page

We will continue to monitor any future changes moving forward. If you have any questions about the Paragraph IV Patent Certifications list and the FDA, how this will affect your company, or for any questions or comments or your regulatory requirement please email to info@mdiconsultants.com or use our contact form.