FDA's shift in policy to awarding 180-day exclusivity to the first generic applicant to file, rather than to the first company to successfully challenge a patent, has significantly increased the number of generics qualifying for the exclusivity.

"Prior to the Mova decision...from September 1984 to January 1997, only three applications qualified for 180-day exclusivity and that was during a 12-plus year timeframe," FDA's Office of Generic Drugs Special Assistant-Regulatory Policy Cecelia Parise said March 20.

FDA's change in regulation was precipitated by the 1998 appeals court decision in Mova v. Shalala, which found that generic exclusivity should be awarded to the first generic applicant to file a Paragraph IV certification, rather than the first to successfully challenge a patent. The "successful defense" provision was removed from FDA's guidance via a Nov. 5, 1998 Federal Register notice.

"Since the Mova decision, from January 1997 through 2001, that's about a four-year timeframe, 28 applications have been granted or determined to be eligible for 180-day exclusivity," Parise told the National Association of Pharmaceutical Manufacturers' bulk pharmaceutical chemical workshop in New York City. NAPM's merger with the Generic Pharmaceutical Association is expected to close April 1.

"It's easier for firms to be eligible for 180-day exclusivity because they do not have to prevail in their lawsuit in order to obtain the 180-day exclusivity," Parise explained.

"Just a small portion of the ANDAs contain Paragraph IV certifications," Parise pointed out. "Since Waxman/Hatch was passed" - between Nov. 24, 1984 and Jan. 30, 2001 - FDA "received 8,259 ANDAs. Only 478 contained Paragraph IV certifications. That's approximately 5.8%."

For the three applications granted generic exclusivity pre-Mova, "the 180-day exclusivity was granted by court decisions," Parise said. "After Mova, five exclusivities were granted based on court decisions. Eleven were not sued." Seven other firms were granted exclusivity after the litigation was settled or dismissed, and five firms have litigation ongoing.

Several of the 28 post-Mova applications have qualified for the exclusivity period, but the 180 days has not yet been triggered. "Currently, we have four applications who are approved and eligible for 180-day exclusivity but they're not marketing their drugs," Parise noted.

Since the agency adopted the "first to file" policy, two firms have relinquished their exclusivity while one company waived the exclusivity to a specific firm, Parise said.

FDA's proposed rule on 180-day exclusivity, issued in August 1999, would require first-filers to notify the agency of plans to waive its exclusivity in favor of a subsequent ANDA. The action would be permitted if a "triggering event" has occurred, such as when a competitor receives a tentative ANDA approval for the same drug (¹ [A#00610320000])

Under the proposed "trigger period," companies would be required to either market their approved generic within six months, or forfeit their exclusivity.

Parise reported that the 180-day final rule is in its "final stages" at FDA. The Bush Administration has issued a moratorium on new rules.

Parise acknowledged recent heightened interest in the "intersection of pediatric exclusivity with 180-day generic drug exclusivity."

Since passage of the FDA Modernization Act (which granted pediatric exclusivity incentives to innovator firms), 24 applications have been granted 180-day exclusivity and 27 applications have received pediatric exclusivity, Parise said. To date, there has been "only one potential overlap that has been identified" between pediatric and generic exclusivity, Parise said.

FDA recently concluded that a brand name company's pediatric exclusivity and a generic firm's Waxman/Hatch exclusivity may run concurrently rather than consecutively, under current law. The decision could render at least part of Barr's 180 days for its generic version of Lilly's Prozac (fluoxetine) unusuable (² Also see "Barr Fluoxetine Will Have Two Months Exclusivity Under "Worst Case"" - Pink Sheet, 12 March, 2001.).

"First To File" Policy Increases Generics Qualifying For 180-Day Exclusivity

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