FDA Improves Transparency and Predictability for Generic Drug Applicants

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The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

FDA announced on June 18, 2019 that it was adding data points to its Paragraph IV Patent Certifications List to better inform generic-drug applicants about the potential for their products to be able to be approved and marketed. This change comes as part of the agency’s effort to promote generic-drug options for patients.

The Paragraph IV Patent Certifications List provides information about exclusivity as it relates to generic-drug challenges of patents on brand drugs. Generic-drug applicants can apply for FDA approval of a generic drug before a patent expires on the brand drug if they assert the patent is invalid, unenforceable, or will not be infringed by the generic drug. This assertion comes in the form of a statement called a Paragraph IV certification, as part of an abbreviated new drug application (ANDA).

FDA has added additional data points to the list, including the status of 180-day exclusivity decisions, dates of first approval, marketing status, and expiration dates of blocking patents. The number of applicants that are potentially eligible for 180-day exclusivity will also be shared, allowing generic-drug manufacturers to determine whether or not to develop a generic version of the drug.


“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,” FDA stated in a press release.

Source: FDA