FDA enhances Paragraph IV Patent Certifications List

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FDA enhances Paragraph IV Patent Certifications List

By Sandra Levy - 08/09/2019
The Food and Drug Administration announced that it is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on brand drug products, or 180-day exclusivity.

A generic applicant can seek FDA approval to market a generic drug product before the expiration of a patent for the corresponding brand drug product by providing in its application a statement asserting that the patent is invalid, unenforceable or will not be infringed by that specific generic drug product. This statement, provided by the generic applicant as part of their abbreviated new drug application, or ANDA, is called a “Paragraph IV certification.”

“Today, we are enhancing the Paragraph IV Patent Certifications List by adding several additional data points, including the status of 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. Providing this information may help subsequent generic drug applicants determine when their products can be approved and marketed,” the FDA said in a statement.

The statement continued, “Before today, the list included the name of the drug product (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that contained a Paragraph IV certification was submitted to the agency. Potential generic applicants may be able to infer from this information whether a generic drug application has been submitted to the FDA that might be eligible for 180-day exclusivity. With the update today, this new data may allow generic applicants to make more informed business decisions about which of their specific generic drug applications have a higher likelihood of being approved sooner. This data may also provide more public transparency into instances in which the FDA approves an ANDA with exclusivity, but the generic product is not marketed for an extended time which among other reasons may signal “gaming” tactics in the generic market.”

The FDA said it is sharing the number of applicants that are potentially eligible for 180-day exclusivity. This information may inform other generic manufacturers’ decisions on whether to develop a generic drug for that product. These new data fields will be included for any drug products that are the subject of ANDAs with Paragraph IV patent certifications.

“Where the possibility of 180-day exclusivity for a product exists, once the exclusivity period has expired or eligibility for exclusivity has been relinquished or has been forfeited by the first generic drug applicants, other generic drugs that meet the approval requirements may then come to market. Our data shows that there are significant price decreases once there are at least three generic drugs on the market,” the FDA said.

Related, though uncommon, sometimes a generic drug manufacturer previously granted final approval for a specific product may be court ordered to cease marketing due to patent infringement.

"To help ensure there’s a transparent process for how we handle post-approval patent infringement court orders and convert a final approval to a tentative approval, we intend to provide clarity to industry on how we handle this process in the near future. Under our Drug Competition Action Plan, we will continue to look to provide greater clarity and transparency to generic drug applicants looking to bring their products to market. We intend to publish additional guidances and take other important policy steps to assist generic drug applicants," the agency said.