US: FDA releases new data to help generic drug competitors


US: FDA releases new data to help generic drug competitors

(Source: RAPS 2019-06-21)

Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday.

Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (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. But potential generic applicants may not have been certain on whether an application previously submitted to FDA might be eligible for 180-day exclusivity.

Now, the Paragraph IV Patent Certifications List will include several new data points, including the status of any 180-day exclusivity decisions for individual drugs, along with other information about the dates of first approval, marketing status and expiration dates of blocking patents.

“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,” FDA said. “In addition, we’re 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 [abbreviated new drug applications] with Paragraph IV patent certifications, beginning today.”

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