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# FDA Enhances Paragraph 4 Patent List
- URL: https://www.fdaweb.com/fda-enhances-paragraph-4-patent-list/
- Published: 2019-06-18T12:00:00.000Z
- Updated: 2026-09-15T01:33:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144361

FDA says it is enhancing the Paragraph 4 patent certification list by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products and information about the dates of first approval, marketing status, and expiration dates of blocking patents. FDA acting commissioner **Ned Sharpless** [says](https://www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increase?ref=fdaweb.com) adding the information “may help subsequent generic drug applicants determine when their products can be approved and marketed.”

According to Sharpless, the update 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. And he says including the new data “may also provide more public transparency into instances in which FDA approved 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 generics market.

Sharpless says the actions are part of an overall broader effort to bolster the competitiveness of the generics market.