FDA Expanding Patent Information Available to Generic Drug Manufacturers

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The FDA said it is expanding a database used by generic drug manufacturers to understand when their product can be approved and marketed.

The FDA said Tuesday it is expanding a database used by generic drug manufacturers to understand when their product can be approved and marketed. The Paragraph IV Patent Certifications List tells drugmakers about 180-day exclusivity related to generic challenges of patents on branded drug products.

Under the Hatch-Waxman amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded drug. As part of that approval process, a generic applicant must provide in its application a “certification” that a patent submitted to FDA by the brand-name drug’s sponsor and listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) is, in the generic drugmaker’s opinion and to the best of its knowledge, invalid, unenforceable, or will not be infringed by the generic product. This certification is called a “Paragraph IV Certification.”


Until now, the list included the name of the drug product, dosage 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. The FDA said it will add 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.

The update may allow other applicants to understand which of their specific generic drug applications may have a higher likelihood of being approved sooner and may provide more transparency into the process. For instance, if the FDA approves an Abbreviated New Drug Application but the generic product is not available for an extended time, it may signal so-called gaming tactics to block competition.

The FDA said it will also include the number of applicants that are potentially eligible for 180-day exclusivity, which will tell other manufacturers about the possible future generic competition for a product.

In addition, the FDA said it plans to clarify how it handles situations where a final approval must be converted to tentative approval if a specific product is ordered to cease marketing due to a patent infringement ruling. Other additional guidance and policy changes to assist generic drug makers are coming, the FDA said.

Generic drugs represent the bulk of US prescriptions, and significant price decreases do not typically occur until there are at least 3 generic drugs on the market, the FDA has said.