FDA expand Paragraph IV Patent Certifications List for generic drugmakers

pharmafile | June 19, 2019 | News story | Research and Development |  FDA, Hatch-Waxman act, generic drugs, generics, pharma 

The FDA has said that it is expanding a database used by generic drugmakers to get information on when their products can be marketed and approved.

The FDA is expanding the Paragraph IV Patent Certifications List to include information on the status of any 180-day exclusivity decisions for individual drug products as well as other information regarding the dates of first approval, marketing status, and expiration dates of blocking patents.

According to the rules put forward by the Hatch-Waxman Act, companies can seek FDA marketing approval for a generic drug before the expiration of patents relating to the branded drug.

As part of the approval process generic drugmakers must put forward a certification saying that the patent on the drug is invalid, unenforceable, or will not be infringed by the generic product.

Currently lists provided by the FDA include information as to the name of the drug, the dosage and strength of the drug and the date on which the first substantially complete generic drug application that contained a Paragraph IV Certification was submitted to the FDA.

The FDA will now add information on any 180-day exclusivity decisions for individual drug products along with other information about the dates of first approval, marketing status, and expiration dates of blocking patents.

It is hoped that the added information will increase transparency and allow drugmakers to get a better idea as to which of their generic drug applications may be approved.

Louis Goss